Trial Outcomes & Findings for Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age (NCT NCT05096208)
NCT ID: NCT05096208
Last Updated: 2023-04-12
Results Overview
Geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. GMTs were reported in the descriptive section. Geometric mean ratios (GMRs) for each RSV vaccine lot comparison (Group 1/Group 2, Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B neutralizing antibody titers was calculated and reported in statistical analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1028 participants
Primary outcome timeframe
1 month (27 to 42 days window) after vaccination on Day 1
Results posted on
2023-04-12
Participant Flow
A total of 1028 participants signed the informed consent form (ICF) and were enrolled. Out of which, 35 participants were not eligible for randomization and 993 participants were randomized into the study. Only 992 participants were vaccinated.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1.
|
Group 1: RSVpreF Lot 1
Participants were randomized to receive a single intramuscular injection of 120 microgram (mcg) Respiratory Syncytial Virus prefusion F subunit vaccine (RSVpreF) Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
247
|
249
|
247
|
250
|
|
Overall Study
Vaccinated
|
247
|
249
|
247
|
249
|
|
Overall Study
COMPLETED
|
243
|
243
|
239
|
245
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1.
|
Group 1: RSVpreF Lot 1
Participants were randomized to receive a single intramuscular injection of 120 microgram (mcg) Respiratory Syncytial Virus prefusion F subunit vaccine (RSVpreF) Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
3
|
|
Overall Study
No longer met eligibility criteria
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
Baseline characteristics by cohort
| Measure |
Placebo
n=247 Participants
Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1.
|
Group 1: RSVpreF Lot 1
n=249 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
n=247 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
n=249 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
Total
n=992 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.46 Years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
34.16 Years
STANDARD_DEVIATION 8.58 • n=7 Participants
|
33.81 Years
STANDARD_DEVIATION 9.02 • n=5 Participants
|
33.90 Years
STANDARD_DEVIATION 9.02 • n=4 Participants
|
34.08 Years
STANDARD_DEVIATION 8.83 • n=21 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
593 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
399 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
248 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
728 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
204 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
178 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
703 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 month (27 to 42 days window) after vaccination on Day 1Population: Evaluable immunogenicity population included all eligible participants who received vaccine to which they were randomized at visit 1, had a valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination and had no other major protocol deviations.
Geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. GMTs were reported in the descriptive section. Geometric mean ratios (GMRs) for each RSV vaccine lot comparison (Group 1/Group 2, Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B neutralizing antibody titers was calculated and reported in statistical analysis.
Outcome measures
| Measure |
Group 1: RSVpreF Lot 1
n=236 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
n=236 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
n=238 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
|---|---|---|---|
|
Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots
RSV A
|
25238.1 Titer
Interval 22867.7 to 27854.2
|
25207.5 Titer
Interval 22360.8 to 28416.6
|
24130.9 Titer
Interval 21536.3 to 27038.1
|
|
Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots
RSV B
|
21701.9 Titer
Interval 19433.1 to 24235.6
|
20317.3 Titer
Interval 17944.4 to 23003.9
|
19238.1 Titer
Interval 16920.0 to 21873.9
|
PRIMARY outcome
Timeframe: Within 7 days after vaccination on Day 1Population: Safety population included all randomized participants who received study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3).
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Group 1: RSVpreF Lot 1
n=247 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
n=742 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Mild
|
10.5 Percentage of participants
Interval 7.0 to 15.0
|
31.5 Percentage of participants
Interval 28.2 to 35.0
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Moderate
|
0.8 Percentage of participants
Interval 0.1 to 2.9
|
5.4 Percentage of participants
Interval 3.9 to 7.3
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Mild
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
4.4 Percentage of participants
Interval 3.1 to 6.2
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Moderate
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
2.8 Percentage of participants
Interval 1.8 to 4.3
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0.5 Percentage of participants
Interval 0.1 to 1.4
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Mild
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
4.0 Percentage of participants
Interval 2.7 to 5.7
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 1.5
|
3.8 Percentage of participants
Interval 2.5 to 5.4
|
—
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after vaccination on Day 1Population: Safety population included all randomized participants who received study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3).
Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was defined as temperature greater than or equal to (\>=)38.0 degrees Celsius (C) and categorized as mild (\>=38.0 to 38.4 degrees C), moderate (\>38.4 to 38.9 degrees C) and severe (\>38.9 to 40.0 degrees C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Group 1: RSVpreF Lot 1
n=247 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
n=742 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Moderate
|
2.4 Percentage of participants
Interval 0.9 to 5.2
|
4.2 Percentage of participants
Interval 2.9 to 5.9
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Mild
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
1.1 Percentage of participants
Interval 0.5 to 2.1
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Mild
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
0.8 Percentage of participants
Interval 0.3 to 1.8
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Moderate
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
0.9 Percentage of participants
Interval 0.4 to 1.9
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
19.4 Percentage of participants
Interval 14.7 to 24.9
|
21.3 Percentage of participants
Interval 18.4 to 24.4
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
12.6 Percentage of participants
Interval 8.7 to 17.3
|
21.0 Percentage of participants
Interval 18.1 to 24.1
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
1.2 Percentage of participants
Interval 0.3 to 3.5
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
18.2 Percentage of participants
Interval 13.6 to 23.6
|
21.3 Percentage of participants
Interval 18.4 to 24.4
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
10.1 Percentage of participants
Interval 6.7 to 14.6
|
14.8 Percentage of participants
Interval 12.3 to 17.6
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Mild
|
4.5 Percentage of participants
Interval 2.2 to 7.8
|
6.3 Percentage of participants
Interval 4.7 to 8.3
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0.5 Percentage of participants
Interval 0.1 to 1.4
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Mild
|
5.7 Percentage of participants
Interval 3.1 to 9.3
|
8.9 Percentage of participants
Interval 6.9 to 11.2
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Moderate
|
4.9 Percentage of participants
Interval 2.5 to 8.3
|
4.2 Percentage of participants
Interval 2.9 to 5.9
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: Severe
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
0.4 Percentage of participants
Interval 0.1 to 1.2
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Mild
|
7.7 Percentage of participants
Interval 4.7 to 11.8
|
17.3 Percentage of participants
Interval 14.6 to 20.2
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Moderate
|
3.2 Percentage of participants
Interval 1.4 to 6.3
|
12.3 Percentage of participants
Interval 10.0 to 14.8
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle Pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0.1 Percentage of participants
Interval 0.0 to 0.7
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Mild
|
2.8 Percentage of participants
Interval 1.1 to 5.8
|
8.2 Percentage of participants
Interval 6.3 to 10.4
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Moderate
|
1.6 Percentage of participants
Interval 0.4 to 4.1
|
6.7 Percentage of participants
Interval 5.0 to 8.8
|
—
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint Pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
PRIMARY outcome
Timeframe: Day of consent (Day 1) through study completion (approximately 1 Month)Population: Safety population included all randomized participants who received study intervention. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3).
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events excluding local reactions and systemic events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; required inpatient hospitalization or prolongation of existing hospitalization; life-threatening ; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Group 1: RSVpreF Lot 1
n=247 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
n=745 Participants
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE
|
6.1 Percentage of participants
Interval 3.4 to 9.8
|
5.8 Percentage of participants
Interval 4.2 to 7.7
|
—
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE
|
0 Percentage of participants
Interval 0.0 to 1.5
|
0 Percentage of participants
Interval 0.0 to 0.5
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 130 other events
Deaths: 0 deaths
Group 1: RSVpreF Lot 1
Serious events: 0 serious events
Other events: 170 other events
Deaths: 0 deaths
Group 2: RSVpreF Lot 2
Serious events: 0 serious events
Other events: 172 other events
Deaths: 0 deaths
Group 3: RSVpreF Lot 3
Serious events: 0 serious events
Other events: 166 other events
Deaths: 0 deaths
RSVpreF Pooled Lots (Groups 1, 2 and 3)
Serious events: 0 serious events
Other events: 508 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=247 participants at risk
Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1.
|
Group 1: RSVpreF Lot 1
n=249 participants at risk
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1.
|
Group 2: RSVpreF Lot 2
n=247 participants at risk
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1.
|
Group 3: RSVpreF Lot 3
n=249 participants at risk
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1.
|
RSVpreF Pooled Lots (Groups 1, 2 and 3)
n=745 participants at risk
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF lots 1, 2 or 3 reconstituted with sterile water for injection, once only on Day 1.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.81%
2/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
1.2%
3/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.67%
5/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
10.9%
27/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
14.1%
35/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
15.4%
38/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
10.8%
27/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
13.4%
100/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Nausea (NAUSEA)
|
6.9%
17/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
9.2%
23/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
11.7%
29/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
10.4%
26/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
10.5%
78/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
1.2%
3/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
2.0%
5/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
1.6%
4/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
1.6%
12/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Axillary pain
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Chest pain
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.80%
2/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.27%
2/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Fatigue
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.27%
2/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Fatigue (FATIGUE)
|
33.2%
82/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
43.0%
107/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
41.7%
103/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
43.0%
107/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
42.6%
317/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Injection site erythema
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
11.3%
28/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
33.3%
83/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
39.3%
97/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
37.8%
94/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
36.8%
274/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Injection site rash
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Injection site swelling
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Pyrexia
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Pyrexia (FEVER)
|
0.81%
2/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
1.6%
4/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
2.8%
7/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
1.6%
4/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
2.0%
15/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Swelling
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
General disorders
Swelling (SWELLING)
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
4.4%
11/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
9.3%
23/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
9.6%
24/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
7.8%
58/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Bronchitis
|
0.81%
2/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
COVID-19
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.80%
2/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.80%
2/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.54%
4/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Ear infection
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Paronychia
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Sinusitis
|
1.6%
4/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.80%
2/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
3/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.27%
2/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Investigations
Blood pressure increased
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
4.5%
11/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
14.9%
37/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
14.2%
35/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
15.7%
39/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
14.9%
111/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
10.9%
27/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
27.3%
68/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
33.2%
82/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
28.1%
70/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
29.5%
220/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Nervous system disorders
Headache
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Nervous system disorders
Headache (HEADACHE)
|
28.3%
70/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
38.2%
95/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
35.6%
88/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
34.5%
86/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
36.1%
269/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Nervous system disorders
Presyncope
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.27%
2/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.27%
2/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.80%
2/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.27%
2/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.81%
2/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.81%
2/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.40%
1/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
|
0.81%
2/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
4.4%
11/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
9.3%
23/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
9.6%
24/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
7.8%
58/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.40%
1/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/247 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.00%
0/249 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
0.13%
1/745 • Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER