Trial Outcomes & Findings for Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011) (NCT NCT01553279)
NCT ID: NCT01553279
Last Updated: 2019-03-28
Results Overview
The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
284 participants
Primary outcome timeframe
Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)
Results posted on
2019-03-28
Participant Flow
Infant participants were enrolled at 11 study sites in the United Kingdom.
Participant milestones
| Measure |
V419 and MCC-TT
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Part 1 (Infant Vaccinations)
STARTED
|
142
|
142
|
|
Part 1 (Infant Vaccinations)
COMPLETED
|
140
|
141
|
|
Part 1 (Infant Vaccinations)
NOT COMPLETED
|
2
|
1
|
|
Interim Period
STARTED
|
140
|
141
|
|
Interim Period
COMPLETED
|
137
|
139
|
|
Interim Period
NOT COMPLETED
|
3
|
2
|
|
Period 2: Toddler Vaccinations
STARTED
|
137
|
139
|
|
Period 2: Toddler Vaccinations
COMPLETED
|
134
|
132
|
|
Period 2: Toddler Vaccinations
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
V419 and MCC-TT
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Part 1 (Infant Vaccinations)
Lost to Follow-up
|
1
|
0
|
|
Part 1 (Infant Vaccinations)
Withdrawal by Subject
|
1
|
1
|
|
Interim Period
Withdrawal by Subject
|
2
|
2
|
|
Interim Period
Lost to Follow-up
|
1
|
0
|
|
Period 2: Toddler Vaccinations
Withdrawal by Subject
|
0
|
5
|
|
Period 2: Toddler Vaccinations
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)
Baseline characteristics by cohort
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 Days
STANDARD_DEVIATION 6.7 • n=99 Participants
|
61.6 Days
STANDARD_DEVIATION 7.2 • n=107 Participants
|
62.1 Days
STANDARD_DEVIATION 7.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=121 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=109 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)
|
100.0 Percentage of Participants
Interval 97.0 to 100.0
|
99.1 Percentage of Participants
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>80%. Serum Ab levels were determined with radioimmunoassay (RIA).
Outcome measures
| Measure |
V419 and MCC-TT
n=175 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)
|
98.9 Percentage of Participants
Interval 95.9 to 99.9
|
—
|
SECONDARY outcome
Timeframe: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=121 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=109 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
Post-MCC Dose 1: % with ≥1:8 dil
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
96.4 Percentage of Participants
Interval 89.9 to 99.3
|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
Post-MCC Dose 1: % with ≥1:128 dil
|
98.0 Percentage of Participants
Interval 93.1 to 99.8
|
84.5 Percentage of Participants
Interval 75.0 to 91.5
|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
Post-MCC Dose 2: % with ≥1:8 dil
|
100.0 Percentage of Participants
Interval 97.0 to 100.0
|
99.1 Percentage of Participants
Interval 95.0 to 100.0
|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
Post-MCC Dose 2: % with ≥1:128 dil
|
99.2 Percentage of Participants
Interval 95.5 to 100.0
|
99.1 Percentage of Participants
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
Post-MCC Dose 1 anti-MCC GMTs
|
1353 Titres
Interval 1058.4 to 1729.6
|
285.0 Titres
Interval 201.5 to 403.1
|
|
Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
Post-MCC Dose 2 anti-MCC GMTs
|
2024.7 Titres
Interval 1689.8 to 2425.9
|
1077.4 Titres
Interval 847.5 to 1369.8
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid \[PT\]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 \[FIM\]; and pertactin \[PRN\]) was determined as 1) if pre-vaccination Ab concentration \<lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-PRP ≥0.15 µg/mL
|
97.8 Percentage of Participants
Interval 92.4 to 99.7
|
100.0 Percentage of Participants
Interval 95.6 to 100.0
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-HBsAG ≥10 mIU/mL
|
96.8 Percentage of Participants
Interval 90.9 to 99.3
|
96.3 Percentage of Participants
Interval 89.7 to 99.2
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-Diptheria ≥0.01 IU/mL
|
100.0 Percentage of Participants
Interval 97.1 to 100.0
|
100.0 Percentage of Participants
Interval 96.5 to 100.0
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-Diptheria ≥0.1 IU/mL
|
68.0 Percentage of Participants
Interval 59.1 to 76.1
|
74.0 Percentage of Participants
Interval 64.5 to 82.1
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-Tetanus ≥0.01 IU/mL
|
100.0 Percentage of Participants
Interval 97.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.5 to 100.0
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-Tetanus ≥0.1 IU/mL
|
100.0 Percentage of Participants
Interval 97.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.5 to 100.0
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-PT seroresponse
|
99.0 Percentage of Participants
Interval 94.6 to 100.0
|
100.0 Percentage of Participants
Interval 95.2 to 100.0
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-FHA seroresponse
|
91.0 Percentage of Participants
Interval 83.6 to 95.8
|
90.5 Percentage of Participants
Interval 81.5 to 96.1
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-PRN seroresponse
|
95.0 Percentage of Participants
Interval 88.7 to 98.4
|
90.4 Percentage of Participants
Interval 81.2 to 96.1
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-FIM seroresponse
|
96.0 Percentage of Participants
Interval 90.1 to 98.9
|
96.0 Percentage of Participants
Interval 88.8 to 99.2
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-Polio 1 ≥ 1:8 dil
|
100.0 Percentage of Participants
Interval 96.8 to 100.0
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-Polio 2 ≥ 1:8 dil
|
100.0 Percentage of Participants
Interval 96.6 to 100.0
|
100.0 Percentage of Participants
Interval 95.9 to 100.0
|
|
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Anti-Polio 3 ≥ 1:8 dil
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 95.1 to 100.0
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)
|
6.44 µg/mL
Interval 4.7 to 8.83
|
8.21 µg/mL
Interval 6.08 to 11.09
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)
|
195.1 mIU/mL
Interval 150.7 to 252.7
|
247.7 mIU/mL
Interval 186.3 to 329.3
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)
|
0.198 IU/mL
Interval 0.165 to 0.237
|
0.22 IU/mL
Interval 0.181 to 0.268
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)
|
1.03 IU/mL
Interval 0.9 to 1.17
|
0.95 IU/mL
Interval 0.82 to 1.1
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)
|
131.5 EU/mL
Interval 117.2 to 147.6
|
133.3 EU/mL
Interval 118.3 to 150.2
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)
|
50.4 EU/mL
Interval 44.8 to 56.6
|
50.1 EU/mL
Interval 43.7 to 57.4
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)
|
90.4 EU/mL
Interval 73.2 to 111.7
|
106.8 EU/mL
Interval 83.7 to 136.3
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)
|
401.7 EU/mL
Interval 339.4 to 475.5
|
441.7 EU/mL
Interval 363.2 to 537.2
|
SECONDARY outcome
Timeframe: Month 5 (1 month after V419 Dose 3)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).
Outcome measures
| Measure |
V419 and MCC-TT
n=125 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
Anti-Polio 3 GMT
|
502.2 titre (1/dil)
Interval 370.2 to 681.4
|
405.1 titre (1/dil)
Interval 284.9 to 576.0
|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
Anti-Polio 1 GMT
|
214 titre (1/dil)
Interval 164.9 to 277.7
|
257.9 titre (1/dil)
Interval 193.8 to 343.1
|
|
Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
Anti-Polio 2 GMT
|
385.2 titre (1/dil)
Interval 288.2 to 514.9
|
400.6 titre (1/dil)
Interval 290.6 to 552.3
|
SECONDARY outcome
Timeframe: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)Population: All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.
The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)
Pre-Hib anti-MCC: % with titre ≥1:8 (1/dil)
|
83.1 Percentage of Participants
Interval 73.7 to 90.2
|
40.4 Percentage of Participants
Interval 30.4 to 51.0
|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)
Pre-Hib anti-MCC: % with titre ≥1:28 (1/dil)
|
40.4 Percentage of Participants
Interval 30.2 to 51.4
|
16.0 Percentage of Participants
Interval 9.2 to 25.0
|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)
Post-Hib anti-MCC: % with titre ≥1:8 (1/dil)
|
100.0 Percentage of Participants
Interval 96.7 to 100.0
|
97.3 Percentage of Participants
Interval 92.2 to 99.4
|
|
Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)
Post-Hib anti-MCC: % with titre ≥1:28 (1/dil)
|
99.1 Percentage of Participants
Interval 95.0 to 100.0
|
95.5 Percentage of Participants
Interval 89.7 to 98.5
|
SECONDARY outcome
Timeframe: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)Population: All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.
Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
Outcome measures
| Measure |
V419 and MCC-TT
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)
Post-Hib anti-MCC GMT
|
3257.9 tire (1/dil)
Interval 2597.4 to 4086.3
|
580.8 tire (1/dil)
Interval 432.7 to 779.5
|
|
Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)
Pre-Hib anti-MCC GMT
|
50.3 tire (1/dil)
Interval 34.4 to 73.4
|
8.7 tire (1/dil)
Interval 5.9 to 12.9
|
SECONDARY outcome
Timeframe: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).
Outcome measures
| Measure |
V419 and MCC-TT
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)
Pre-Hib-MCC anti-PRP ≥0.15 µg/mL
|
93.9 Percentage of Participants
Interval 86.3 to 98.0
|
95.4 Percentage of Participants
Interval 88.6 to 98.7
|
|
Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)
Pre-Hib-MCC anti-PRP ≥1.0 µg/mL
|
54.9 Percentage of Participants
Interval 43.5 to 65.9
|
56.3 Percentage of Participants
Interval 45.3 to 66.9
|
|
Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)
Post-Hib-MCC anti-PRP ≥0.15 µg/mL
|
100.0 Percentage of Participants
Interval 96.7 to 100.0
|
100.0 Percentage of Participants
Interval 96.6 to 100.0
|
|
Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)
Post-Hib-MCC anti-PRP ≥1.0 µg/mL
|
99.1 Percentage of Participants
Interval 95.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.6 to 100.0
|
SECONDARY outcome
Timeframe: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)Population: All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.
Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..
Outcome measures
| Measure |
V419 and MCC-TT
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=111 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
Pre-Hib-MCC anti-PRP ≥1.0 µg/mL
|
100.19 µg/mL
Interval 81.05 to 123.86
|
121.00 µg/mL
Interval 101.11 to 144.8
|
|
Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
Pre-Hib-MCC anti-PRP ≥0.15 µg/mL
|
1.09 µg/mL
Interval 0.81 to 1.45
|
1.18 µg/mL
Interval 0.9 to 1.55
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]
|
98.6 Percentage of Participants
Interval 95.0 to 99.8
|
97.2 Percentage of Participants
Interval 92.9 to 99.2
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]
|
98.6 Percentage of Participants
Interval 95.0 to 99.8
|
96.5 Percentage of Participants
Interval 92.0 to 98.8
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
Erythema
|
71.1 Percentage of Participants
Interval 62.9 to 78.4
|
64.8 Percentage of Participants
Interval 56.3 to 72.6
|
|
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
Pain
|
63.4 Percentage of Participants
Interval 54.9 to 71.3
|
66.2 Percentage of Participants
Interval 57.8 to 73.9
|
|
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
Swelling
|
51.4 Percentage of Participants
Interval 42.9 to 59.9
|
47.2 Percentage of Participants
Interval 38.8 to 55.7
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
|
6.3 Percentage of Participants
Interval 2.9 to 11.7
|
11.3 Percentage of Participants
Interval 6.6 to 17.7
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Erythema
|
56.3 Percentage of Participants
Interval 47.8 to 64.6
|
45.8 Percentage of Participants
Interval 37.4 to 54.3
|
|
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Pain
|
41.5 Percentage of Participants
Interval 33.3 to 50.1
|
45.8 Percentage of Participants
Interval 37.4 to 54.3
|
|
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Swelling
|
35.9 Percentage of Participants
Interval 28.0 to 44.4
|
28.2 Percentage of Participants
Interval 20.9 to 36.3
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Bruising
|
1.4 Percentage of Participants
|
4.2 Percentage of Participants
|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Dermatitis
|
0 Percentage of Participants
|
0.7 Percentage of Participants
|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Erythema
|
0 Percentage of Participants
|
0.7 Percentage of Participants
|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Induration
|
1.4 Percentage of Participants
|
0.7 Percentage of Participants
|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Mass
|
3.5 Percentage of Participants
|
2.1 Percentage of Participants
|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Pain
|
0 Percentage of Participants
|
0.7 Percentage of Participants
|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Rash
|
1.4 Percentage of Participants
|
0.7 Percentage of Participants
|
|
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Warmth
|
0 Percentage of Participants
|
2.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
Vomiting
|
40.1 Percentage of Participants
|
49.3 Percentage of Participants
|
|
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
Crying
|
85.9 Percentage of Participants
|
81.0 Percentage of Participants
|
|
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
Decreased appetite
|
63.4 Percentage of Participants
|
64.8 Percentage of Participants
|
|
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
Irritability
|
88.0 Percentage of Participants
|
81.0 Percentage of Participants
|
|
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
Pyrexia
|
11.3 Percentage of Participants
|
10.6 Percentage of Participants
|
|
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
Somnolence
|
81.7 Percentage of Participants
|
78.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
The percentage of participants experiencing temperatures ≥38.0° Celsius (C), \>38.5° C, and \>39.5° C following any Part 1 vaccination was determined.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing Increased Temperature [Part 1]
% ≥38.0° C
|
11.3 Percentage of Participants
|
10.6 Percentage of Participants
|
|
Percentage of Participants Experiencing Increased Temperature [Part 1]
% >38.5° C
|
1.4 Percentage of Participants
|
2.1 Percentage of Participants
|
|
Percentage of Participants Experiencing Increased Temperature [Part 1]
% >39.5° C
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)Population: All randomized participants who received ≥1 dose of study medication in Part 1 are included.
An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.
Outcome measures
| Measure |
V419 and MCC-TT
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 Participants
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]
|
4.2 Percentage of Participants
Interval 1.6 to 9.0
|
2.8 Percentage of Participants
Interval 0.8 to 7.1
|
Adverse Events
V419 and MCC-TT
Serious events: 6 serious events
Other events: 140 other events
Deaths: 0 deaths
V419 and MCC-CRM
Serious events: 4 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V419 and MCC-TT
n=142 participants at risk
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 participants at risk
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Crying
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Hypothermia
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Croup infectious
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Sepsis neonatal
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Urinary tract infection
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
Other adverse events
| Measure |
V419 and MCC-TT
n=142 participants at risk
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
V419 and MCC-CRM
n=142 participants at risk
In Part 1, participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age). In Part 2, participants received a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.8%
4/142 • Number of events 4 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
2.1%
3/142 • Number of events 5 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
11/142 • Number of events 15 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
5.6%
8/142 • Number of events 11 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Gastrointestinal disorders
Teething
|
4.9%
7/142 • Number of events 8 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Gastrointestinal disorders
Vomiting
|
40.1%
57/142 • Number of events 93 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
50.0%
71/142 • Number of events 112 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Crying
|
85.9%
122/142 • Number of events 273 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
81.0%
115/142 • Number of events 262 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Injection site bruising
|
2.8%
4/142 • Number of events 4 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
4.9%
7/142 • Number of events 12 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Injection site erythema
|
73.2%
104/142 • Number of events 342 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
67.6%
96/142 • Number of events 305 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Injection site mass
|
3.5%
5/142 • Number of events 5 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
2.1%
3/142 • Number of events 4 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Injection site pain
|
65.5%
93/142 • Number of events 258 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
70.4%
100/142 • Number of events 267 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Injection site swelling
|
54.9%
78/142 • Number of events 211 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
49.3%
70/142 • Number of events 177 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Injection site warmth
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
2.1%
3/142 • Number of events 4 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Irritability
|
88.0%
125/142 • Number of events 301 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
81.0%
115/142 • Number of events 286 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
General disorders
Pyrexia
|
13.4%
19/142 • Number of events 22 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
12.7%
18/142 • Number of events 23 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
11/142 • Number of events 12 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
8.5%
12/142 • Number of events 14 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Infections and infestations
Rhinitis
|
5.6%
8/142 • Number of events 8 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
4.2%
6/142 • Number of events 7 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/142 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
2.1%
3/142 • Number of events 3 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
64.1%
91/142 • Number of events 164 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
64.8%
92/142 • Number of events 167 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Nervous system disorders
Somnolence
|
81.7%
116/142 • Number of events 227 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
78.9%
112/142 • Number of events 231 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Psychiatric disorders
Insomnia
|
2.8%
4/142 • Number of events 4 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
0.70%
1/142 • Number of events 1 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
12/142 • Number of events 13 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
4.2%
6/142 • Number of events 6 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.8%
4/142 • Number of events 6 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
1.4%
2/142 • Number of events 2 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.8%
4/142 • Number of events 4 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
2.8%
4/142 • Number of events 4 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
8/142 • Number of events 8 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
4.2%
6/142 • Number of events 7 • Up to 12.5 months (up to 14 days after the final dose of study medication)
All participants who received ≥1 dose of study medication are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place