Trial Outcomes & Findings for Evaluation of Full Versus Fractional Dose of COVID-19 Vaccine Given as a Booster for the Prevention of COVID-19 in Adults in Mongolia. (NCT NCT05265065)
NCT ID: NCT05265065
Last Updated: 2026-03-24
Results Overview
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of \<200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of \>200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
601 participants
Primary outcome timeframe
28-days post booster vaccination
Results posted on
2026-03-24
Participant Flow
There are two study arms (i.e. groups to which participants were randomised), as per "Arms and Interventions" in Protocol Section, corresponding to the primary analysis comparing a full dose to a fractional dose. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The Participant Flow was edited to reflect the randomisation of participants into two arms.
Participant milestones
| Measure |
Standard
30µg Pfizer-BioNTech booster dose
|
Fractional
15µg Pfizer-BioNTech booster dose
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
301
|
|
Overall Study
Received allocated d dose
|
299
|
299
|
|
Overall Study
Included in Day 28 immunogenicity analysis
|
292
|
295
|
|
Overall Study
COMPLETED
|
282
|
285
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AstraZeneca (ChAdOx1-S, or Vaxzevria®) - Standard Pfizer-BioNTech Booster Group
n=65 Participants
Previously received two doses of AstraZeneca as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
AstraZeneca (ChAdOx1-S, or Vaxzevria®) - Fractional Pfizer-BioNTech Booster Group
n=65 Participants
Previously received two doses of AstraZeneca as primary COVID-19 vaccine
.
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
n=201 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
n=200 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
n=34 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
n=36 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=65 Participants
|
0 Participants
n=65 Participants
|
3 Participants
n=201 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=601 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=65 Participants
|
65 Participants
n=65 Participants
|
189 Participants
n=201 Participants
|
186 Participants
n=200 Participants
|
30 Participants
n=34 Participants
|
35 Participants
n=36 Participants
|
570 Participants
n=601 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=65 Participants
|
0 Participants
n=65 Participants
|
9 Participants
n=201 Participants
|
14 Participants
n=200 Participants
|
4 Participants
n=34 Participants
|
1 Participants
n=36 Participants
|
28 Participants
n=601 Participants
|
|
Age, Continuous
|
34.5 years
n=65 Participants
|
40.2 years
n=65 Participants
|
47.8 years
n=201 Participants
|
48.8 years
n=200 Participants
|
43.1 years
n=34 Participants
|
41.3 years
n=36 Participants
|
44 years
n=601 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=65 Participants
|
32 Participants
n=65 Participants
|
115 Participants
n=201 Participants
|
114 Participants
n=200 Participants
|
19 Participants
n=34 Participants
|
14 Participants
n=36 Participants
|
327 Participants
n=601 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=65 Participants
|
33 Participants
n=65 Participants
|
86 Participants
n=201 Participants
|
86 Participants
n=200 Participants
|
15 Participants
n=34 Participants
|
22 Participants
n=36 Participants
|
274 Participants
n=601 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mongolia
|
65 participants
n=65 Participants
|
65 participants
n=65 Participants
|
201 participants
n=201 Participants
|
200 participants
n=200 Participants
|
34 participants
n=34 Participants
|
36 participants
n=36 Participants
|
601 participants
n=601 Participants
|
|
BMI
|
26.3 kg/m2
n=65 Participants
|
25.4 kg/m2
n=65 Participants
|
24.6 kg/m2
n=201 Participants
|
24.8 kg/m2
n=200 Participants
|
25.3 kg/m2
n=34 Participants
|
25.8 kg/m2
n=36 Participants
|
25.2 kg/m2
n=601 Participants
|
PRIMARY outcome
Timeframe: 28-days post booster vaccinationPopulation: The analysis of immunogenicity endpoints included all participants with outcome data. There are two study arms, as per "Arms and Interventions" in Protocol Section, corresponding to the primary analysis comparing a full dose to a fractional dose. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The primary outcome is unstratified.
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of \<200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of \>200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection.
Outcome measures
| Measure |
Standard
n=292 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=295 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Seroresponse
|
253 Participants
|
250 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days post booster vaccinationPopulation: The reactogenicity and safety analysis populations included all randomised participants who received a study vaccine, according to the vaccine received. There are two study arms, as per "Arms and Interventions" in Protocol Section. Stratified randomisation was performed to ensure balanced randomisation according to the primary vaccine received (prior to this study) and age for secondary subgroup analyses. The primary outcome is unstratified.
Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report grade 3 or 4 reactions by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration, swelling, fever, nausea, vomiting, headache, fatigue/malaise, myalgia, arthralgia, diarrhea, enlarged lymph nodes will be collected from the participants 7 days post-vaccination.
Outcome measures
| Measure |
Standard
n=299 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=299 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Solicited Grade 3 or 4 Local or Systemic Reaction
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28-days post booster vaccinationPopulation: The analysis of immunogenicity endpoints included all participants with outcome data
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. The primary endpoint is the seroresponse rate at the Day-28 visit. The seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of \<200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of \>200 BAU/ml, or a ≥4-times the lower limit of detection if baseline levels are lower than the limit of detection. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®)
Outcome measures
| Measure |
Standard
n=65 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=62 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
n=194 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
n=198 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
n=33 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
n=35 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Seroresponse by Priming Vaccine Strata
|
55 Participants
|
52 Participants
|
170 Participants
|
169 Participants
|
28 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 28-days post booster vaccinationPopulation: The analysis of immunogenicity endpoints included all participants with outcome data.
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA.
Outcome measures
| Measure |
Standard
n=292 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=295 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
SARS-CoV-2 Specific IgG Antibodies at Day-28
|
4946 BAU/ml
Interval 4614.0 to 5302.0
|
4619 BAU/ml
Interval 4292.0 to 4970.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28-days post booster vaccinationPopulation: The analysis of immunogenicity endpoints included all participants with outcome data
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG ELISA. Priming strata (previously COVID vaccination): AstraZeneca (ChAdOx1-S, or Vaxzevria®); Sinopharm (BBIBP-CorV®); Sputnik V (Gam-COVID-Vac®)
Outcome measures
| Measure |
Standard
n=65 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=62 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
n=194 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
n=198 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
n=33 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
n=35 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
SARS-CoV-2 Specific IgG Antibodies at Day-28 by Priming Vaccine Strata
|
4394 BAU/ml
Interval 3863.0 to 4997.0
|
4167 BAU/ml
Interval 3550.0 to 4892.0
|
5109 BAU/ml
Interval 4678.0 to 5580.0
|
4970 BAU/ml
Interval 4541.0 to 5438.0
|
5160 BAU/ml
Interval 4128.0 to 6450.0
|
3662 BAU/ml
Interval 3016.0 to 4447.0
|
SECONDARY outcome
Timeframe: Baseline (pre booster), 28 days, 6 months, 12 months, 18 months, and 24 months post-booster vaccination.Population: Standard arm: baseline 1 withdrawn; day 28: 6 missed, 1 withdrawn; 6 months: 9 missed, 4 withdrawn, 1 lost to follow up (LTFU); 12 months: 5 missed, 3 withdrawn; 18 months: 8 missed, 17 withdrawn, 1 LTFU; 24 months: 5 withdrawn, 7 LTFU. Fractional arm: baseline 1 withdrawn; day 28: 4 missed, 1 withdrawn; 6 months: 6 missed, 3 withdrawn, 1 sample not taken; 12 months: 3 missed, 5 withdrawn, 1 LTFU; 18 months: 9 missed, 12 withdrawn, 4 LTFU; 24 months: 6 withdrawn, 8 LTFU.
Serum samples collected at baseline (pre booster), 28 days, 6 months, 12 months, 18 months, and 24 months post booster vaccination from the study arms will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units (BAU)/mL and presented as geometric mean concentration (GMC) and 95% confidence intervals (CI).
Outcome measures
| Measure |
Standard
n=299 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=300 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination.
Baseline anti-spike IgG GMC (95% CI)
|
969 binding antibody units (BAU/mL)
Interval 876.0 to 1072.0
|
929 binding antibody units (BAU/mL)
Interval 839.0 to 1029.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination.
28 days anti-spike IgG GMC (95% CI)
|
4946 binding antibody units (BAU/mL)
Interval 4614.0 to 5302.0
|
4619 binding antibody units (BAU/mL)
Interval 4292.0 to 4970.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination.
6 months anti-spike IgG GMC (95% CI)
|
2085 binding antibody units (BAU/mL)
Interval 1926.0 to 2256.0
|
2123 binding antibody units (BAU/mL)
Interval 1964.0 to 2296.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination.
12 months anti-spike IgG GMC (95% CI)
|
2204 binding antibody units (BAU/mL)
Interval 2030.0 to 2393.0
|
2208 binding antibody units (BAU/mL)
Interval 2027.0 to 2404.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination.
18 months anti-spike IgG GMC (95% CI)
|
1336 binding antibody units (BAU/mL)
Interval 1231.0 to 1450.0
|
1425 binding antibody units (BAU/mL)
Interval 1313.0 to 1546.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific IgG Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination.
24 months anti-spike IgG GMC (95% CI)
|
1051 binding antibody units (BAU/mL)
Interval 973.0 to 1135.0
|
1107 binding antibody units (BAU/mL)
Interval 1021.0 to 1199.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-booster), 28 days, 6 months, 12 months, 18 months, and 24 months post-booster vaccination.Population: Participant numbers vary because some missed visits or withdrew. One baseline sample was not collected. Follow-up blood collection was 98% at Day 28, 96% at 6 months, 95% at 12 months, 88% at 18 months, and 87% at 24 months. By 24 months, 59 withdrew for relocation, voluntary withdrawal, death, or investigator decision, and 22 were lost to follow-up.
Serum samples collected at baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific neutralising antibodies using the GenScript® cPass surrogate virus neutralization test (sVNT) for both wild-type and Omicron variant. Neutralising antibody response will be reported as percentage (%) inhibition of receptor binding domain-angiotensin-converting enzyme 2 (RBD-ACE2) binding relative to a positive control.
Outcome measures
| Measure |
Standard
n=299 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=300 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
Baseline Wuhan-Hu-1 SARS-CoV-2 sVNT inhibition
|
81 percentage (%) inhibition
Interval 76.0 to 85.0
|
81 percentage (%) inhibition
Interval 77.0 to 84.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
28 days Wuhan-Hu-1 SARS-CoV-2 sVNT inhibition
|
81 percentage (%) inhibition
Interval 78.0 to 84.0
|
81 percentage (%) inhibition
Interval 78.0 to 84.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
6 months Wuhan-Hu-1 SARS-CoV-2 sVNT inhibition
|
89 percentage (%) inhibition
Interval 88.0 to 91.0
|
89 percentage (%) inhibition
Interval 88.0 to 91.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
12 months Wuhan-Hu-1 SARS-CoV-2 sVNT inhibition
|
89 percentage (%) inhibition
Interval 88.0 to 90.0
|
89 percentage (%) inhibition
Interval 87.0 to 90.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
18 months Wuhan-Hu-1 SARS-CoV-2 sVNT inhibition
|
88 percentage (%) inhibition
Interval 87.0 to 90.0
|
88 percentage (%) inhibition
Interval 86.0 to 90.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
24 months Wuhan-Hu-1 SARS-CoV-2 sVNT inhibition
|
88 percentage (%) inhibition
Interval 86.0 to 89.0
|
88 percentage (%) inhibition
Interval 86.0 to 90.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
Baseline Omicron BA.1 SARS-CoV-2 sVNT inhibition
|
52 percentage (%) inhibition
Interval 17.0 to 77.0
|
51 percentage (%) inhibition
Interval 18.0 to 76.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
28 days Omicron BA.1 SARS-CoV-2 sVNT inhibition
|
82 percentage (%) inhibition
Interval 75.0 to 85.0
|
81 percentage (%) inhibition
Interval 75.0 to 84.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
6 months Omicron BA.1 SARS-CoV-2 sVNT inhibition
|
74 percentage (%) inhibition
Interval 46.0 to 87.0
|
77 percentage (%) inhibition
Interval 48.0 to 87.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
12 months Omicron BA.1 SARS-CoV-2 sVNT inhibition
|
76 percentage (%) inhibition
Interval 44.0 to 87.0
|
79 percentage (%) inhibition
Interval 40.0 to 87.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
18 months Omicron BA.1 SARS-CoV-2 sVNT inhibition
|
81 percentage (%) inhibition
Interval 61.0 to 86.0
|
81 percentage (%) inhibition
Interval 64.0 to 86.0
|
—
|
—
|
—
|
—
|
|
SARS-CoV-2 Specific Neutralising Antibodies at Baseline (Pre-booster), 28 Days, 6 Months, 12 Months, 18 Months, and 24 Months Post-booster Vaccination Measured by Surrogate Virus Neutralisation Test (sVNT).
24 months Omicron BA.1 SARS-CoV-2 sVNT inhibition
|
84 percentage (%) inhibition
Interval 71.0 to 88.0
|
85 percentage (%) inhibition
Interval 70.0 to 88.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre booster), 28 days-, 6- and 12-months post booster vaccinationA subset of samples (20%) from all four timepoints will be assessed using a SARS-CoV-2 microneutralisation assay to both the wild type (vaccine) strain and for two SARS-CoV-2 Variants of concern. Neutralizing antibody will be reported as endpoint titre.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre booster), 28 days, 6-, 12 -, 18-, and 24-months post booster vaccinationPopulation: Participant numbers differ because only 256 enrolled in the CMI substudy, with equal allocation by arm. Evaluable IGRA samples varied by visit due to missed visits or unavailable specimens. Sample completeness ranged from \~93-95% early to \~86% at 24 months. Thus, each row reflects only participants with valid samples at that time point, not the full substudy cohort.
IFN-γ concentrations (IU/mL) as a measure of cellular immunity will be assessed in a subset of participants. IFN-γ production will be stimulated using QuantiFERON Human IFN-γ SARS-CoV-2 (Qiagen) and quantified by ELISA. Results are summarised as geometric mean concentrations (GMCs) with 95% confidence intervals.
Outcome measures
| Measure |
Standard
n=128 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=128 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
6 month IFN-γ Ag1
|
0.27 IU/mL
Interval 0.21 to 0.34
|
0.33 IU/mL
Interval 0.26 to 0.42
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
12 month IFN-γ Ag1
|
0.28 IU/mL
Interval 0.22 to 0.36
|
0.30 IU/mL
Interval 0.23 to 0.39
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
Baseline IFN-γ Ag1
|
0.26 IU/mL
Interval 0.2 to 0.34
|
0.31 IU/mL
Interval 0.23 to 0.41
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
28 day IFN-γ Ag1
|
0.46 IU/mL
Interval 0.37 to 0.58
|
0.60 IU/mL
Interval 0.47 to 0.77
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
18 month IFN-γ Ag1
|
0.21 IU/mL
Interval 0.15 to 0.28
|
0.28 IU/mL
Interval 0.21 to 0.37
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
24 month IFN-γ Ag1
|
0.27 IU/mL
Interval 0.2 to 0.37
|
0.35 IU/mL
Interval 0.28 to 0.46
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
Baseline IFN-γ Ag2
|
0.32 IU/mL
Interval 0.24 to 0.41
|
0.38 IU/mL
Interval 0.3 to 0.49
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
28 day IFN-γ Ag2
|
0.64 IU/mL
Interval 0.51 to 0.79
|
0.75 IU/mL
Interval 0.6 to 0.94
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
6 month IFN-γ Ag2
|
0.34 IU/mL
Interval 0.27 to 0.42
|
0.42 IU/mL
Interval 0.33 to 0.54
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
12 month IFN-γ Ag2
|
0.44 IU/mL
Interval 0.34 to 0.57
|
0.59 IU/mL
Interval 0.47 to 0.73
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
18 month IFN-γ Ag2
|
0.42 IU/mL
Interval 0.32 to 0.55
|
0.49 IU/mL
Interval 0.38 to 0.64
|
—
|
—
|
—
|
—
|
|
Interferon Gamma (IFNγ) Concentrations in International Units (IU)/mL
24 month IFN-γ Ag2
|
0.34 IU/mL
Interval 0.26 to 0.45
|
0.42 IU/mL
Interval 0.33 to 0.54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-booster), 28 days, 6 and 12 months post booster vaccinationPopulation: ELISpot analyses of wild-type SARS-CoV-2 spike-specific IFN-γ responses were conducted in a predefined subset of participants with additional blood collection. Approximately 40% of participants in each arm were included in this cellular immunity substudy. The numbers analysed at each time point reflect participants with available and valid ELISpot results and therefore differ from the total number of participants randomised to each arm.
Applicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants (40%) from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% CI.
Outcome measures
| Measure |
Standard
n=96 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=96 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Number of IFNγ Producing Cells/Million PBMCs
6 months
|
88 IFN-γ SFU per 10⁶ cells
Interval 50.0 to 156.0
|
80 IFN-γ SFU per 10⁶ cells
Interval 43.0 to 147.0
|
—
|
—
|
—
|
—
|
|
Number of IFNγ Producing Cells/Million PBMCs
Baseline
|
43 IFN-γ SFU per 10⁶ cells
Interval 24.0 to 77.0
|
40 IFN-γ SFU per 10⁶ cells
Interval 21.0 to 75.0
|
—
|
—
|
—
|
—
|
|
Number of IFNγ Producing Cells/Million PBMCs
28 days
|
118 IFN-γ SFU per 10⁶ cells
Interval 77.0 to 181.0
|
127 IFN-γ SFU per 10⁶ cells
Interval 87.0 to 185.0
|
—
|
—
|
—
|
—
|
|
Number of IFNγ Producing Cells/Million PBMCs
12 months
|
86 IFN-γ SFU per 10⁶ cells
Interval 50.0 to 147.0
|
82 IFN-γ SFU per 10⁶ cells
Interval 48.0 to 141.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-booster), 28 days, 6 and 12 months post-booster vaccinationPopulation: ICS analyses were conducted in a predefined subset of participants (\~40%) who provided additional blood samples. The numbers analysed at each time point reflect participants with available and valid ICS results and therefore differ from the total number randomised.
Frequency of wild-type SARS-CoV-2 spike-specific cytokine-expressing T cells will be assessed in a subset of participants (\~40%) using intracellular cytokine staining (ICS) by flow cytometry on PBMC samples. Results are reported as the frequency (%) of cytokine-expressing CD4 and CD8 memory T cells, summarised as geometric mean concentrations (GMCs) with 95% confidence intervals.
Outcome measures
| Measure |
Standard
n=96 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=96 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Frequency of Cytokine-expressing T Cells
Baseline
|
0.007 % of cytokine-expressing T cells
Interval 0.004 to 0.013
|
0.008 % of cytokine-expressing T cells
Interval 0.005 to 0.015
|
—
|
—
|
—
|
—
|
|
Frequency of Cytokine-expressing T Cells
28 days
|
0.014 % of cytokine-expressing T cells
Interval 0.008 to 0.026
|
0.015 % of cytokine-expressing T cells
Interval 0.008 to 0.027
|
—
|
—
|
—
|
—
|
|
Frequency of Cytokine-expressing T Cells
6 months
|
0.010 % of cytokine-expressing T cells
Interval 0.006 to 0.019
|
0.011 % of cytokine-expressing T cells
Interval 0.006 to 0.02
|
—
|
—
|
—
|
—
|
|
Frequency of Cytokine-expressing T Cells
12 months
|
0.019 % of cytokine-expressing T cells
Interval 0.011 to 0.033
|
0.010 % of cytokine-expressing T cells
Interval 0.006 to 0.019
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre booster), 28 days-, 6 and 12 months post booster vaccinationPopulation: Multiplex cytokine analyses were conducted in a predefined subset of participants with additional blood collection. Approximately 40% of participants in each arm were included in this cellular immunity substudy. The numbers analysed at each time point reflect participants with available and valid multiplex cytokine assay results and therefore differ from the total number of participants randomised to each arm.
Wild-type SARS-CoV-2 spike-specific cytokine concentrations following PBMC stimulation will be assessed in a predefined subset of participants (approximately 40%) using multiplex cytokine assays. Cytokine concentrations will be reported in pg/mL and summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. IFN-γ ELISpot, intracellular cytokine staining (flow cytometry), and multiplex cytokine assays will be performed on isolated peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
Standard
n=128 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=128 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI
Baseline
|
2.77 pg/mL
Interval 1.54 to 4.98
|
3.64 pg/mL
Interval 2.15 to 6.16
|
—
|
—
|
—
|
—
|
|
Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI
28 days
|
11.71 pg/mL
Interval 7.45 to 18.39
|
14.74 pg/mL
Interval 9.3 to 23.35
|
—
|
—
|
—
|
—
|
|
Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI
6 months
|
4.38 pg/mL
Interval 2.3 to 8.35
|
6.22 pg/mL
Interval 3.43 to 11.29
|
—
|
—
|
—
|
—
|
|
Cellular Immunity: Multiplex Cytokine Assays - Reported as Cytokine Concentrations in pg/ml and Presented as GMC and 95% CI
12 months
|
7.61 pg/mL
Interval 4.4 to 13.16
|
10.71 pg/mL
Interval 6.69 to 17.14
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days-post booster vaccinationPopulation: The reactogenicity and safety analysis populations included all randomised participants who received a study vaccine, according to the vaccine received
All unsolicited AE will be collected for 28 days post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE.
Outcome measures
| Measure |
Standard
n=65 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=64 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
n=200 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
n=199 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
n=34 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
n=36 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Incidence of Unsolicited Adverse Events (AE)
|
5 Participants
|
9 Participants
|
12 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 months post booster vaccinationAll participants with medically attended AE will be collected for 3 months post booster vaccination. Data will be presented as number of participants who report unsolicited AE.
Outcome measures
| Measure |
Standard
n=300 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=301 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Incidence of Medically Attended Adverse Events
|
19 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 months post-boosterSAE will be collected throughout the follow-up period of 24 months post booster vaccination. Data will be presented as a proportion of participants who report unsolicited SAE.
Outcome measures
| Measure |
Standard
n=65 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=65 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
n=201 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
n=200 Participants
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
n=34 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
n=36 Participants
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Incidence of Serious Adverse Events (SAE)
|
6 Participants
|
6 Participants
|
17 Participants
|
17 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months post booster vaccinationConfirmed SARS-CoV-2 infections will be documented throughout the follow-up period, by clinical severity.
Outcome measures
| Measure |
Standard
n=300 Participants
30µg Pfizer-BioNTech booster dose
|
Fractional
n=301 Participants
15µg Pfizer-BioNTech booster dose
|
Sinopharm (BBIBP-CorV®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sinopharm (BBIBP-CorV®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Standard Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Sputnik V (Gam-COVID-Vac®)- Fractional Pfizer-BioNTech Booster Group
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Incidence of PCR Confirmed COVID-19 Infection
|
14 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 18 and 24 months post booster vaccinationApplicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants (40%) from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% CI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 and 24 months post-booster vaccinationFrequency of wild-type SARS-CoV-2 spike-specific cytokine-expressing T cells will be assessed in a subset of participants (\~40%) using intracellular cytokine staining (ICS) by flow cytometry on PBMC samples. Results are reported as the frequency (%) of cytokine-expressing CD4 and CD8 memory T cells, summarised as geometric mean concentrations (GMCs) with 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 and 24 months post booster vaccinationWild-type SARS-CoV-2 spike-specific cytokine concentrations following PBMC stimulation will be assessed in a predefined subset of participants (approximately 40%) using multiplex cytokine assays. Cytokine concentrations will be reported in pg/mL and summarised as geometric mean concentrations (GMCs) with 95% confidence intervals. IFN-γ ELISpot, intracellular cytokine staining (flow cytometry), and multiplex cytokine assays will be performed on isolated peripheral blood mononuclear cells (PBMCs).
Outcome measures
Outcome data not reported
Adverse Events
Standard Pfizer-BioNTech Booster Group- AstraZeneca
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fractional Pfizer-BioNTech Booster Group- AstraZeneca
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard Pfizer-BioNTech Booster Group- Sinopharm
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Fractional Pfizer-BioNTech Booster Group- Sinopharm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard Pfizer-BioNTech Booster Group- Sputnik
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Fractional Pfizer-BioNTech Booster Group- Sputnik
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Pfizer-BioNTech Booster Group- AstraZeneca
n=65 participants at risk
Previously received two doses of AstraZeneca as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Fractional Pfizer-BioNTech Booster Group- AstraZeneca
n=65 participants at risk
Previously received two doses of AstraZeneca as primary COVID-19 vaccine.
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Standard Pfizer-BioNTech Booster Group- Sinopharm
n=201 participants at risk
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Fractional Pfizer-BioNTech Booster Group- Sinopharm
n=200 participants at risk
Previously received two doses of Sinopharm as primary COVID-19 vaccine.
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Standard Pfizer-BioNTech Booster Group- Sputnik
n=34 participants at risk
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Fractional Pfizer-BioNTech Booster Group- Sputnik
n=36 participants at risk
Previously received two doses of Sputnik as primary COVID-19 vaccine.
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatobiliary
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.9%
1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
Other adverse events
| Measure |
Standard Pfizer-BioNTech Booster Group- AstraZeneca
n=65 participants at risk
Previously received two doses of AstraZeneca as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Fractional Pfizer-BioNTech Booster Group- AstraZeneca
n=65 participants at risk
Previously received two doses of AstraZeneca as primary COVID-19 vaccine.
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Standard Pfizer-BioNTech Booster Group- Sinopharm
n=201 participants at risk
Previously received two doses of Sinopharm as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Fractional Pfizer-BioNTech Booster Group- Sinopharm
n=200 participants at risk
Previously received two doses of Sinopharm as primary COVID-19 vaccine.
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
Standard Pfizer-BioNTech Booster Group- Sputnik
n=34 participants at risk
Previously received two doses of Sputnik as primary COVID-19 vaccine
Tozinameran - Standard Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 30 µg in 0.3 ml. Liquid for injection. Single dose.
|
Fractional Pfizer-BioNTech Booster Group- Sputnik
n=36 participants at risk
Previously received two doses of Sputnik as primary COVID-19 vaccine.
Tozinameran - Fractional Dose: Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cellfree in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Dose - 15 µg in 0.15 ml. Liquid for injection. Single dose.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal cramps
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Infections and infestations
Acute respiratory tract infection
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.8%
1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Infections and infestations
Acute upper respiratory tract infection
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.9%
1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.8%
1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Immune system disorders
Allergy to chemicals
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
General disorders
Fatigue
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Infections and infestations
Furuncle
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Nervous system disorders
Headache
|
3.1%
2/65 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.00%
2/201 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.0%
2/200 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.9%
1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.8%
1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
5.9%
2/34 • Number of events 2 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.8%
1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/200 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Social circumstances
Natural menopause
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.9%
1/34 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
2.8%
1/36 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/65 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/201 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
1.5%
1/65 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.50%
1/201 • Number of events 1 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/200 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/34 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
0.00%
0/36 • Solicited local and systemic adverse events (AEs) were collected from the participants 7 days post-vaccination Unsolicited AEs up to 28 days following vaccination observed by the Investigator or reported by the participant, whether or not attributed to study medication, were also collected. Serious adverse events (SAE's) will be followed up for the duration of the trial up to 24 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place