Trial Outcomes & Findings for A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above (NCT NCT05921903)
NCT ID: NCT05921903
Last Updated: 2026-06-11
Results Overview
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
386 participants
Primary outcome timeframe
At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)
Results posted on
2026-06-11
Participant Flow
386 participants were enrolled in the study, received at least 1 dose of the study intervention and were included in the Exposed set.
Participant milestones
| Measure |
RSV_IC_1 Group
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_IC_2 Group
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
|
RSV_HA Group
Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
|---|---|---|---|
|
Overall Study
STARTED
|
131
|
130
|
125
|
|
Overall Study
COMPLETED
|
129
|
125
|
123
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
RSV_IC_1 Group
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_IC_2 Group
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
|
RSV_HA Group
Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
|---|---|---|---|
|
Overall Study
Unsolicited non-SAE
|
0
|
1
|
0
|
|
Overall Study
SAEs/pIMDs/AESIs specific to SOT
|
1
|
3
|
1
|
|
Overall Study
Withdrawal by participant: burden of procedure
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by participant: participant relocated
|
1
|
0
|
1
|
Baseline Characteristics
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
Baseline characteristics by cohort
| Measure |
RSV_IC_1 Group
n=131 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_IC_2 Group
n=130 Participants
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
|
RSV_HA Group
n=125 Participants
Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.1 YEARS
STANDARD_DEVIATION 9.3 • n=20 Participants
|
61.4 YEARS
STANDARD_DEVIATION 8.4 • n=20 Participants
|
63.8 YEARS
STANDARD_DEVIATION 8.2 • n=40 Participants
|
62.4 YEARS
STANDARD_DEVIATION 8.7 • n=6 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=20 Participants
|
50 Participants
n=20 Participants
|
66 Participants
n=40 Participants
|
170 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=20 Participants
|
80 Participants
n=20 Participants
|
59 Participants
n=40 Participants
|
216 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
89 Participants
n=20 Participants
|
79 Participants
n=20 Participants
|
95 Participants
n=40 Participants
|
263 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
92 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
11 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
23 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)Population: Analysis was performed on Per protocol Set (PPS) for humoral immunogenicity, which included all participants who received the study intervention administration as per protocol, had immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available for the RSV-A MGI at the specified timepoint were included in the analysis.
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
Outcome measures
| Measure |
RSV_IC_1 Group
n=111 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group
|
1.34 Ratio
Interval 1.2 to 1.48
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B MGI at the specified timepoint were included in this analysis.
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
Outcome measures
| Measure |
RSV_IC_1 Group
n=111 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group
|
1.26 Ratio
Interval 1.14 to 1.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1+ 7-14 days), Visit 3 (Visit 1+ 30-60 days), Visit 4 (Visit 3+ 30-42 days), Visit 5 (last dose+ 180-210 days) and Visit 6 (last dose+ 350-380 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A and RSV-B GMTs at the specified timepoints were included in this analysis.
Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 \[ED60\]).
Outcome measures
| Measure |
RSV_IC_1 Group
n=123 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=123 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=125 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-A , Visit 4
|
4184.7 Titers (ED60)
Interval 3360.1 to 5211.7
|
5377.9 Titers (ED60)
Interval 4265.4 to 6780.6
|
5707.0 Titers (ED60)
Interval 4853.6 to 6710.3
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-A , Visit 5
|
3220.8 Titers (ED60)
Interval 2637.4 to 3933.3
|
3954.5 Titers (ED60)
Interval 3205.4 to 4878.6
|
3958.4 Titers (ED60)
Interval 3372.2 to 4646.6
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-A , Visit 6
|
1773.4 Titers (ED60)
Interval 1486.2 to 2116.2
|
2517.4 Titers (ED60)
Interval 2039.3 to 3107.5
|
2243.6 Titers (ED60)
Interval 1925.0 to 2614.9
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-B, Visit 1
|
864.2 Titers (ED60)
Interval 727.8 to 1026.2
|
892.9 Titers (ED60)
Interval 754.1 to 1057.3
|
1027.3 Titers (ED60)
Interval 889.6 to 1186.3
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-B, Visit 2
|
2325.3 Titers (ED60)
Interval 1592.9 to 3394.5
|
2603.1 Titers (ED60)
Interval 1714.9 to 3951.3
|
8113.6 Titers (ED60)
Interval 5699.9 to 11549.5
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-B, Visit 3
|
5002.9 Titers (ED60)
Interval 3901.7 to 6414.8
|
4834.7 Titers (ED60)
Interval 3736.6 to 6255.6
|
9125.2 Titers (ED60)
Interval 7781.9 to 10700.5
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-B, Visit 4
|
4461.7 Titers (ED60)
Interval 3519.0 to 5657.0
|
5820.8 Titers (ED60)
Interval 4658.2 to 7273.5
|
6281.6 Titers (ED60)
Interval 5377.6 to 7337.7
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-B, Visit 5
|
2926.9 Titers (ED60)
Interval 2364.0 to 3623.8
|
3620.7 Titers (ED60)
Interval 2974.9 to 4406.7
|
3584.5 Titers (ED60)
Interval 3093.6 to 4153.3
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-B, Visit 6
|
2206.7 Titers (ED60)
Interval 1811.3 to 2688.5
|
2886.5 Titers (ED60)
Interval 2368.0 to 3518.4
|
2665.1 Titers (ED60)
Interval 2310.9 to 3073.5
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-A , Visit 3
|
3990.8 Titers (ED60)
Interval 3219.4 to 4947.0
|
4174.0 Titers (ED60)
Interval 3230.7 to 5392.6
|
6881.3 Titers (ED60)
Interval 5976.2 to 7923.6
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-A , Visit 1
|
807.0 Titers (ED60)
Interval 700.9 to 929.2
|
814.1 Titers (ED60)
Interval 701.3 to 945.1
|
889.0 Titers (ED60)
Interval 781.9 to 1010.6
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups
RSV-A , Visit 2
|
1775.8 Titers (ED60)
Interval 1201.0 to 2625.6
|
2031.1 Titers (ED60)
Interval 1283.6 to 3213.9
|
6716.8 Titers (ED60)
Interval 4907.6 to 9193.0
|
—
|
SECONDARY outcome
Timeframe: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=117 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=235 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups
Visit 3
|
6714.9 Titers (ED60)
Interval 5549.8 to 8124.7
|
4111.4 Titers (ED60)
Interval 3594.3 to 4703.1
|
—
|
—
|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups
Visit 2
|
6689.9 Titers (ED60)
Interval 4639.3 to 9646.7
|
1902.8 Titers (ED60)
Interval 1479.6 to 2446.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=118 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=110 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Visit 5
|
3198.7 Titers (ED60)
Interval 2642.2 to 3872.5
|
3726.3 Titers (ED60)
Interval 3035.9 to 4573.8
|
—
|
—
|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Visit 4
|
4041.9 Titers (ED60)
Interval 3254.8 to 5019.3
|
5098.4 Titers (ED60)
Interval 4088.8 to 6357.3
|
—
|
—
|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Visit 6
|
1737.0 Titers (ED60)
Interval 1459.2 to 2067.8
|
2360.0 Titers (ED60)
Interval 1966.4 to 2832.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=118 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=115 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Visit 4
|
4244.8 Titers (ED60)
Interval 3551.8 to 5073.0
|
5541.6 Titers (ED60)
Interval 4622.0 to 6644.2
|
—
|
—
|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Visit 5
|
3359.9 Titers (ED60)
Interval 2856.5 to 3952.1
|
3804.2 Titers (ED60)
Interval 3227.3 to 4484.1
|
—
|
—
|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Visit 6
|
1830.8 Titers (ED60)
Interval 1578.6 to 2123.4
|
2192.9 Titers (ED60)
Interval 1889.6 to 2545.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=110 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=115 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Visit 4
|
5505.3 Titers (ED60)
Interval 4627.0 to 6550.3
|
5615.7 Titers (ED60)
Interval 4719.8 to 6681.6
|
—
|
—
|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Visit 5
|
4032.4 Titers (ED60)
Interval 3426.2 to 4746.0
|
3895.6 Titers (ED60)
Interval 3336.5 to 4548.5
|
—
|
—
|
|
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Visit 6
|
2555.4 Titers (ED60)
Interval 2196.4 to 2973.1
|
2214.8 Titers (ED60)
Interval 1914.0 to 2562.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=117 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=235 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups
Visit 3
|
8590.8 Titers (ED60)
Interval 7063.8 to 10448.0
|
5087.8 Titers (ED60)
Interval 4432.0 to 5840.5
|
—
|
—
|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups
Visit 2
|
8238.7 Titers (ED60)
Interval 5972.9 to 11364.1
|
2442.6 Titers (ED60)
Interval 1958.3 to 3046.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT ratio of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=119 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=110 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Visit 4
|
4333.3 Titers (ED60)
Interval 3510.0 to 5349.8
|
5550.5 Titers (ED60)
Interval 4478.3 to 6879.4
|
—
|
—
|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Visit 5
|
2906.8 Titers (ED60)
Interval 2453.2 to 3444.2
|
3346.4 Titers (ED60)
Interval 2788.7 to 4015.7
|
—
|
—
|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups
Visit 6
|
2158.5 Titers (ED60)
Interval 1851.8 to 2516.0
|
2689.2 Titers (ED60)
Interval 2290.5 to 3157.2
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=119 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=115 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Visit 4
|
4632.9 Titers (ED60)
Interval 3890.8 to 5516.6
|
5973.5 Titers (ED60)
Interval 5000.9 to 7135.4
|
—
|
—
|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Visit 5
|
3128.7 Titers (ED60)
Interval 2686.0 to 3644.2
|
3390.7 Titers (ED60)
Interval 2903.4 to 3960.0
|
—
|
—
|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups
Visit 6
|
2331.2 Titers (ED60)
Interval 2035.7 to 2669.6
|
2552.1 Titers (ED60)
Interval 2227.3 to 2924.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-B group GMT for the specified groups at the specified timepoints were included in this analysis.
Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4, Visit 5 and Visit 6. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Outcome measures
| Measure |
RSV_IC_1 Group
n=110 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=115 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Visit 6
|
3003.2 Titers (ED60)
Interval 2631.4 to 3427.4
|
2608.9 Titers (ED60)
Interval 2296.8 to 2963.5
|
—
|
—
|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Visit 4
|
6090.6 Titers (ED60)
Interval 5184.6 to 7155.0
|
6123.0 Titers (ED60)
Interval 5212.1 to 7193.0
|
—
|
—
|
|
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups
Visit 5
|
3770.5 Titers (ED60)
Interval 3294.6 to 4315.1
|
3509.7 Titers (ED60)
Interval 3087.0 to 3990.1
|
—
|
—
|
SECONDARY outcome
Timeframe: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days), each compared to Visit 1 (Day 1)Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for RSV-A and RSV-B MGI for the specified groups at the specified timepoints were included in this analysis.
MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV\_HA and pooled RSV\_IC (combined RSV\_IC\_1 and RSV\_IC\_2 groups), and at Visit 4, Visit 5 and Visit 6 over Visit 1 in RSV\_IC\_1, RSV\_IC\_2, RSV\_HA groups.
Outcome measures
| Measure |
RSV_IC_1 Group
n=122 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=113 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=117 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
n=235 Participants
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-A, Visit 2
|
2.38 Ratio
Interval 1.61 to 3.53
|
2.36 Ratio
Interval 1.56 to 3.58
|
8.48 Ratio
Interval 6.01 to 11.96
|
2.37 Ratio
Interval 1.8 to 3.14
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-B, Visit 6
|
2.58 Ratio
Interval 2.2 to 3.04
|
3.17 Ratio
Interval 2.73 to 3.68
|
2.69 Ratio
Interval 2.35 to 3.08
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-A, Visit 5
|
4.46 Ratio
Interval 3.65 to 5.44
|
4.77 Ratio
Interval 3.93 to 5.79
|
4.54 Ratio
Interval 3.91 to 5.27
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-A, Visit 3
|
5.55 Ratio
Interval 4.44 to 6.95
|
5.90 Ratio
Interval 4.69 to 7.41
|
8.77 Ratio
Interval 7.56 to 10.17
|
5.72 Ratio
Interval 4.88 to 6.7
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-A, Visit 4
|
6.88 Ratio
Interval 5.49 to 8.61
|
8.58 Ratio
Interval 6.92 to 10.62
|
7.78 Ratio
Interval 6.66 to 9.09
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-A, Visit 6
|
2.70 Ratio
Interval 2.26 to 3.22
|
3.50 Ratio
Interval 2.96 to 4.14
|
2.98 Ratio
Interval 2.56 to 3.47
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-B, Visit 2
|
2.51 Ratio
Interval 1.78 to 3.55
|
2.54 Ratio
Interval 1.75 to 3.67
|
8.59 Ratio
Interval 6.59 to 11.2
|
2.53 Ratio
Interval 1.98 to 3.23
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-B, Visit 3
|
5.72 Ratio
Interval 4.53 to 7.21
|
5.34 Ratio
Interval 4.25 to 6.72
|
8.95 Ratio
Interval 7.81 to 10.25
|
5.53 Ratio
Interval 4.71 to 6.51
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-B, Visit 4
|
5.22 Ratio
Interval 4.2 to 6.49
|
6.52 Ratio
Interval 5.34 to 7.97
|
6.35 Ratio
Interval 5.5 to 7.33
|
—
|
|
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI
RSV-B, Visit 5
|
3.52 Ratio
Interval 2.92 to 4.25
|
3.95 Ratio
Interval 3.38 to 4.61
|
3.59 Ratio
Interval 3.13 to 4.1
|
—
|
SECONDARY outcome
Timeframe: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on the PPS for cell mediated immunity (CMI) \[CMI subset\], which included all participants who received the study intervention administration, had cell mediated immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available for CD4+ T cells at the specified timepoints were included in analysis.
CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group).
Outcome measures
| Measure |
RSV_IC_1 Group
n=24 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=28 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=31 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells
Visit 1
|
86.8 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 1.0
|
110.3 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.9
|
107.8 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.9
|
—
|
|
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells
Visit 2
|
2932.2 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.6
|
3704.3 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.5
|
2959.8 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.3
|
—
|
|
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells
Visit 3
|
1049.0 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.8
|
1626.7 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.3
|
1042.4 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.3
|
—
|
|
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells
Visit 4
|
910.8 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.8
|
2709.0 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.3
|
734.4 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.3
|
—
|
|
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells
Visit 5
|
845.4 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.5
|
1452.7 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.4
|
503.7 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.6
|
—
|
|
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells
Visit 6
|
794.4 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.5
|
1131.9 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.5
|
506.4 Specific CD4+ Tcells/million CD4+ Tcells
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days), Visit 4 (Visit 3 + 30-42 days), Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)Population: Analysis was performed on PPS for CMI \[CMI subset\]. Only participants with data available for CD8+ T cells for the specified groups at the specified timepoints were included in this analysis.
CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group).
Outcome measures
| Measure |
RSV_IC_1 Group
n=22 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=26 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=27 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells
Visit 4
|
12.0 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
16.9 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 0.9
|
13.2 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
—
|
|
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells
Visit 5
|
12.6 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.0
|
14.4 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
8.2 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
—
|
|
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells
Visit 1
|
33.9 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.0
|
8.2 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
27.7 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.0
|
—
|
|
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells
Visit 2
|
16.0 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.2
|
8.7 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.0
|
13.0 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.2
|
—
|
|
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells
Visit 3
|
21.7 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 0.8
|
22.3 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
21.0 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
—
|
|
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells
Visit 6
|
14.2 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.0
|
20.5 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
10.6 Specific CD8+ Tcells/million CD8+ Tcells
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)Population: Analysis was performed on the Exposed set (ES) which included all participants who received the study intervention administration. Only participants with solicited administration site events at the specified time periods were included in this analysis.
Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
RSV_IC_1 Group
n=131 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=128 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=125 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
Number Of Participants Reporting Any Solicited Administration Site Events
Erythema, Within 7 days from Dosing at Visit 1
|
8 Participants
|
14 Participants
|
11 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Administration Site Events
Pain, Within 7 days from Dosing at Visit 1
|
95 Participants
|
92 Participants
|
95 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Administration Site Events
Pain, Within 7 days from Dosing at Visit 3
|
—
|
82 Participants
|
—
|
—
|
|
Number Of Participants Reporting Any Solicited Administration Site Events
Erythema, Within 7 days from Dosing at Visit 3
|
—
|
10 Participants
|
—
|
—
|
|
Number Of Participants Reporting Any Solicited Administration Site Events
Swelling, Within 7 days from Dosing at Visit 1
|
8 Participants
|
11 Participants
|
3 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Administration Site Events
Swelling, Within 7 days from Dosing at Visit 3
|
—
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)Population: Analysis was performed on the ES. Only participants with solicited systemic events at the specified time periods were included in this analysis.
Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
RSV_IC_1 Group
n=131 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=128 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=125 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
Number Of Participants Reporting Any Solicited Systemic Events
Myalgia, Within 7 days from Dosing at Visit 1
|
37 Participants
|
38 Participants
|
49 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Myalgia, Within 7 days from Dosing at Visit 3
|
—
|
38 Participants
|
—
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Arthralgia, Within 7 days from Dosing at Visit 1
|
19 Participants
|
15 Participants
|
15 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Fever, Within 7 days from Dosing at Visit 1
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Fever, Within 7 days from Dosing at Visit 3
|
—
|
2 Participants
|
—
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Arthralgia, Within 7 days from Dosing at Visit 3
|
—
|
19 Participants
|
—
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Headache, Within 7 days from Dosing at Visit 1
|
31 Participants
|
33 Participants
|
44 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Headache, Within 7 days from Dosing at Visit 3
|
—
|
30 Participants
|
—
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Fatigue, Within 7 days from Dosing at Visit 1
|
41 Participants
|
45 Participants
|
48 Participants
|
—
|
|
Number Of Participants Reporting Any Solicited Systemic Events
Fatigue, Within 7 days from Dosing at Visit 3
|
—
|
47 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)Population: Analysis was performed on the ES. Only participants with unsolicited AEs at the specified timepoints were included in the analysis.
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Outcome measures
| Measure |
RSV_IC_1 Group
n=131 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=130 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=125 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration
Within 7 days from Dosing at Visit 1
|
23 Participants
|
33 Participants
|
27 Participants
|
—
|
|
Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration
Within 7 days from Dosing at Visit 3
|
—
|
39 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)Population: Analysis was performed on the ES.
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of intensity grade or relation to study intervention. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of intensity grade or relation to study intervention.
Outcome measures
| Measure |
RSV_IC_1 Group
n=131 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=130 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=125 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs
Any SAEs
|
29 Participants
|
37 Participants
|
4 Participants
|
—
|
|
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs
Related SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs
Fatal SAEs
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)Population: Analysis was performed on the ES.
pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of intensity grade or relation to study intervention. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
RSV_IC_1 Group
n=131 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=130 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=125 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention
Any pIMD
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention
Related pIMD
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Visit 1 (Day 1) up to Visit 6 (last dose + 350-380 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)Population: Analysis was performed on the ES. Only SOT participants that had data available at the specified timepoints were included in the analysis.
AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\_IC\_1 and RSV\_IC\_2 groups.
Outcome measures
| Measure |
RSV_IC_1 Group
n=131 Participants
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
n=130 Participants
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_HA Group
Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
Pooled RSV_IC Group
IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
|
|---|---|---|---|---|
|
Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung Solid Organ Transplant (SOT) Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
RSV_IC_1 Group
Serious events: 29 serious events
Other events: 106 other events
Deaths: 3 deaths
RSV_IC_2 Group
Serious events: 37 serious events
Other events: 120 other events
Deaths: 3 deaths
RSV_HA Group
Serious events: 4 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RSV_IC_1 Group
n=131 participants at risk
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_IC_2 Group
n=130 participants at risk
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
|
RSV_HA Group
n=125 participants at risk
Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
2.3%
3/131 • Number of events 5 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
3.8%
5/130 • Number of events 6 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Sepsis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
3.1%
4/130 • Number of events 6 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
COVID-19
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
3.1%
4/130 • Number of events 4 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
2/131 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/131 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Urosepsis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Gangrene
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Bursitis infective
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Influenza
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome with excess blasts
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.3%
3/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Chest pain
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Pyrexia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.3%
3/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Septic shock
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Aspergillus infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
HCoV-NL63 infection
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Actinomycosis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Cellulitis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Diverticulitis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Hepatic cyst infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Histoplasmosis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Nocardiosis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Norovirus infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pantoea agglomerans infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Sinusitis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Pancreatitis (
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell endometrial carcinoma
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Ischaemic stroke
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Myelopathy
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Spinal cord compression
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Asthenia
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
2/131 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Vascular disorders
Deep vein thrombosis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
Other adverse events
| Measure |
RSV_IC_1 Group
n=131 participants at risk
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
RSV_IC_2 Group
n=130 participants at risk
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
|
RSV_HA Group
n=125 participants at risk
Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
3.1%
4/130 • Number of events 4 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.6%
2/125 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
COVID-19
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Gastroenteritis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Sinusitis
|
1.5%
2/131 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Bronchitis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Cystitis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Stenotrophomonas maltophilia pneumonia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Gingivitis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Oral herpes
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
3.2%
4/125 • Number of events 4 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.4%
3/125 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.6%
2/125 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.6%
2/125 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Chest pain
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Administration site pruritus
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
3.8%
5/130 • Number of events 5 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Oedema peripheral
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.3%
3/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Chills
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Administration site pain
|
72.5%
95/131 • Number of events 95 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
83.1%
108/130 • Number of events 174 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
76.0%
95/125 • Number of events 96 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Axillary pain
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Fatigue
|
31.3%
41/131 • Number of events 41 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
46.9%
61/130 • Number of events 92 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
39.2%
49/125 • Number of events 49 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Injection site warmth
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Asthenia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Feeling hot
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Malaise
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Swelling
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Vaccination site bruising
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Feeling abnormal
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Injection site pruritus
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Pyrexia
|
2.3%
3/131 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.3%
3/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Headache
|
24.4%
32/131 • Number of events 32 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
35.4%
46/130 • Number of events 67 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
35.2%
44/125 • Number of events 47 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Dizziness
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.3%
3/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.6%
2/125 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Migraine
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Syncope
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Nervous system disorders
Taste disorder
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.0%
38/131 • Number of events 38 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
43.1%
56/130 • Number of events 77 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
39.2%
49/125 • Number of events 50 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.3%
3/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.5%
19/131 • Number of events 19 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
20.8%
27/130 • Number of events 36 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
12.0%
15/125 • Number of events 15 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
3.8%
5/130 • Number of events 6 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.3%
3/130 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Intestinal mucosal hypertrophy
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
1.5%
2/130 • Number of events 2 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Vascular disorders
Hypertension
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Eye disorders
Asthenopia
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Eye disorders
Eye pruritus
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Pseudallescheria infection
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Administration site erythema
|
6.1%
8/131 • Number of events 8 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
14.6%
19/130 • Number of events 24 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
8.8%
11/125 • Number of events 11 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Administration site swelling
|
6.1%
8/131 • Number of events 8 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
10.0%
13/130 • Number of events 16 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
2.4%
3/125 • Number of events 3 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
General disorders
Injection site haematoma
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.80%
1/125 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/131 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.77%
1/130 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
|
Infections and infestations
Fungal disease carrier
|
0.76%
1/131 • Number of events 1 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/130 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
0.00%
0/125 • Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 6 (last dose + 350-380 days).
Three fatal SAEs, resulting in deaths, occurred in participants after they had completed their last scheduled study visit, but prior to the overall study's Last Subject Last Visit milestone. As these fatalities did not result in withdrawal from the study, they were not included in the 'Reasons for not completing' section of the Participant Flow. These fatal SAEs are reported under the 'All-Cause Mortality' and 'Serious Adverse Events' sections within the Adverse Events module.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER