Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea (NCT NCT06593587)
NCT ID: NCT06593587
Last Updated: 2026-02-09
Results Overview
Local reactions included redness, swelling and pain at injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: \> 2.0 cm to 5.0 cm, moderate: \> 5.0 cm to 10.0 cm, severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity, severe: prevented daily activity. Any local reaction: any redness, any swelling, or pain at the injection site of at least mild severity. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
378 participants
Primary outcome timeframe
From Day 1 to Day 7 after vaccination
Results posted on
2026-02-09
Participant Flow
This study was conducted at 16 sites in the Republic of Korea.
A total of 384 participants were screened, out of which 6 were screen failures and 378 participants were randomized 2:1 to receive respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) or placebo.
Participant milestones
| Measure |
RSVpreF 120 mcg
Participants were randomized to receive a single dose of RSVpreF 120 microgram (mcg) intramuscularly on Day 1.
|
Placebo
Participants were randomized to receive a single dose of placebo intramuscularly on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
252
|
126
|
|
Overall Study
Vaccinated
|
251
|
126
|
|
Overall Study
COMPLETED
|
250
|
126
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
RSVpreF 120 mcg
Participants were randomized to receive a single dose of RSVpreF 120 microgram (mcg) intramuscularly on Day 1.
|
Placebo
Participants were randomized to receive a single dose of placebo intramuscularly on Day 1.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Randomized, not vaccinated
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea
Baseline characteristics by cohort
| Measure |
RSVpreF 120 mcg
n=251 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 Years
STANDARD_DEVIATION 5.18 • n=362 Participants
|
67.3 Years
STANDARD_DEVIATION 5.19 • n=3 Participants
|
67.3 Years
STANDARD_DEVIATION 5.17 • n=7 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=362 Participants
|
76 Participants
n=3 Participants
|
244 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=362 Participants
|
50 Participants
n=3 Participants
|
133 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
251 Participants
n=362 Participants
|
126 Participants
n=3 Participants
|
377 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic/non-Latino
|
251 Participants
n=362 Participants
|
126 Participants
n=3 Participants
|
377 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccinationPopulation: Safety population included all screened participants who received the study intervention in the study.
Local reactions included redness, swelling and pain at injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: \> 2.0 cm to 5.0 cm, moderate: \> 5.0 cm to 10.0 cm, severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity, severe: prevented daily activity. Any local reaction: any redness, any swelling, or pain at the injection site of at least mild severity. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=251 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: any
|
3.2 Percentage of participants
Interval 0.9 to 7.9
|
12.4 Percentage of participants
Interval 8.5 to 17.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: mild
|
2.4 Percentage of participants
Interval 0.5 to 6.8
|
11.6 Percentage of participants
Interval 7.9 to 16.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: moderate
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
0.8 Percentage of participants
Interval 0.1 to 2.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at injection site: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: any
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
2.8 Percentage of participants
Interval 1.1 to 5.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: mild
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
1.6 Percentage of participants
Interval 0.4 to 4.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: moderate
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0.8 Percentage of participants
Interval 0.1 to 2.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: any
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
1.6 Percentage of participants
Interval 0.4 to 4.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: mild
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
1.2 Percentage of participants
Interval 0.2 to 3.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: moderate
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Any local reaction: any
|
3.2 Percentage of participants
Interval 0.9 to 7.9
|
14.7 Percentage of participants
Interval 10.6 to 19.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Any local reaction: mild
|
2.4 Percentage of participants
Interval 0.5 to 6.8
|
12.4 Percentage of participants
Interval 8.5 to 17.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Any local reaction: moderate
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
2.0 Percentage of participants
Interval 0.6 to 4.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Any local reaction: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccinationPopulation: Safety population included all screened participants who received the study intervention in the study.
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain. Fever defined as oral temperature \>=38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C, and Grade 4: \>40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, nausea, muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=251 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0°C
|
1.6 Percentage of participants
Interval 0.2 to 5.6
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0°C to 38.4°C
|
1.6 Percentage of participants
Interval 0.2 to 5.6
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.4°C to 38.9°C
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0.4 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.9°C to 40.0°C
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >40.0°C
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: any
|
26.2 Percentage of participants
Interval 18.8 to 34.8
|
23.1 Percentage of participants
Interval 18.0 to 28.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: mild
|
15.9 Percentage of participants
Interval 10.0 to 23.4
|
17.9 Percentage of participants
Interval 13.4 to 23.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: moderate
|
10.3 Percentage of participants
Interval 5.6 to 17.0
|
5.2 Percentage of participants
Interval 2.8 to 8.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: any
|
11.1 Percentage of participants
Interval 6.2 to 17.9
|
12.7 Percentage of participants
Interval 8.9 to 17.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: mild
|
8.7 Percentage of participants
Interval 4.4 to 15.1
|
11.6 Percentage of participants
Interval 7.9 to 16.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: moderate
|
2.4 Percentage of participants
Interval 0.5 to 6.8
|
1.2 Percentage of participants
Interval 0.2 to 3.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: any
|
9.5 Percentage of participants
Interval 5.0 to 16.0
|
15.5 Percentage of participants
Interval 11.3 to 20.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: mild
|
5.6 Percentage of participants
Interval 2.3 to 11.1
|
12.0 Percentage of participants
Interval 8.2 to 16.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: moderate
|
4.0 Percentage of participants
Interval 1.3 to 9.0
|
3.6 Percentage of participants
Interval 1.7 to 6.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: any
|
7.9 Percentage of participants
Interval 3.9 to 14.1
|
9.2 Percentage of participants
Interval 5.9 to 13.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: mild
|
4.0 Percentage of participants
Interval 1.3 to 9.0
|
6.0 Percentage of participants
Interval 3.4 to 9.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: moderate
|
4.0 Percentage of participants
Interval 1.3 to 9.0
|
3.2 Percentage of participants
Interval 1.4 to 6.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: any
|
6.3 Percentage of participants
Interval 2.8 to 12.1
|
3.6 Percentage of participants
Interval 1.7 to 6.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: mild
|
4.0 Percentage of participants
Interval 1.3 to 9.0
|
3.6 Percentage of participants
Interval 1.7 to 6.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: moderate
|
2.4 Percentage of participants
Interval 0.5 to 6.8
|
0 Percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Nausea: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: any
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: mild
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: moderate
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Vomiting: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: any
|
4.0 Percentage of participants
Interval 1.3 to 9.0
|
4.8 Percentage of participants
Interval 2.5 to 8.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: mild
|
4.0 Percentage of participants
Interval 1.3 to 9.0
|
4.8 Percentage of participants
Interval 2.5 to 8.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: moderate
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Diarrhea: severe
|
0 Percentage of participants
Interval 0.0 to 2.9
|
0 Percentage of participants
Interval 0.0 to 1.5
|
PRIMARY outcome
Timeframe: From vaccination on Day 1 up to 1 month after vaccinationPopulation: Safety population included all screened participants who received the study intervention in the study.
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. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=251 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
3.6 Percentage of participants
Interval 1.7 to 6.7
|
PRIMARY outcome
Timeframe: From vaccination on Day 1 up to 2 months after vaccinationPopulation: Safety population included all screened participants who received the study intervention in the study.
An SAE was defined as an AE that, at any dose met one of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other significant medical events as judged by investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=251 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination Throughout the Study
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
0.8 Percentage of participants
Interval 0.1 to 2.8
|
PRIMARY outcome
Timeframe: From vaccination on Day 1 up to 2 months after vaccinationPopulation: Safety population included all screened participants who received the study intervention in the study.
A NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=251 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Throughout the Study
|
0 Percentage of participants
Interval 0.0 to 2.9
|
1.2 Percentage of participants
Interval 0.2 to 3.5
|
PRIMARY outcome
Timeframe: Before VaccinationPopulation: Evaluable immunogenicity population: all participants who were eligible and received the study intervention to which they were randomized, had 1-month postvaccination blood collection visit within 27 to 42 days after vaccination, had at least 1 valid and determinate assay result 1 month after vaccination and had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here "Number Analyzed" refers to number of participants evaluable for specified rows.
GMTs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ for analysis.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=249 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Neutralizing Titers (NTs) for RSV A and RSV B Before Vaccination
RSV A
|
1617 Titer
Interval 1402.0 to 1866.0
|
1472 Titer
Interval 1326.0 to 1636.0
|
|
Geometric Mean Titer (GMT) of Neutralizing Titers (NTs) for RSV A and RSV B Before Vaccination
RSV B
|
1865 Titer
Interval 1601.0 to 2174.0
|
1957 Titer
Interval 1766.0 to 2168.0
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: Evaluable immunogenicity population: all participants who were eligible and received the study intervention to which they were randomized, had 1-month postvaccination blood collection visit within 27 to 42 days after vaccination, had at least 1 valid and determinate assay result 1 month after vaccination and had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here "Number Analyzed" refers to number of participants evaluable for specified rows.
GMTs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ for analysis.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=249 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Neutralizing Titers (NTs) for RSV A and RSV B at 1 Month After Vaccination
RSV A
|
1397 Titer
Interval 1199.0 to 1628.0
|
14240 Titer
Interval 12977.0 to 15625.0
|
|
Geometric Mean Titer (GMT) of Neutralizing Titers (NTs) for RSV A and RSV B at 1 Month After Vaccination
RSV B
|
1813 Titer
Interval 1554.0 to 2115.0
|
16277 Titer
Interval 14623.0 to 18117.0
|
PRIMARY outcome
Timeframe: From before vaccination to 1 month after vaccinationPopulation: Evaluable immunogenicity population: all participants who were eligible and received the study intervention to which they were randomized, had 1-month postvaccination blood collection visit within 27 to 42 days after vaccination, had at least 1 valid and determinate assay result 1 month after vaccination and had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here "Number Analyzed" refers to number of participants evaluable for specified rows.
Fold rises was defined as ratios of the results after vaccination to the results before vaccination. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=249 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Neutralizing Titers (NTs) for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
RSV A
|
0.9 Fold rise
Interval 0.78 to 0.94
|
9.5 Fold rise
Interval 8.51 to 10.67
|
|
Geometric Mean Fold Rise (GMFR) of Neutralizing Titers (NTs) for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
RSV B
|
1.0 Fold rise
Interval 0.89 to 1.06
|
8.3 Fold rise
Interval 7.37 to 9.39
|
SECONDARY outcome
Timeframe: 1 month after vaccinationPopulation: Evaluable immunogenicity population: all participants who were eligible and received the study intervention to which they were randomized, had 1-month postvaccination blood collection visit within 27 to 42 days after vaccination, had at least 1 valid and determinate assay result 1 month after vaccination and had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here "Number Analyzed" refers to number of participants evaluable for specified rows.
Seroresponse rate was defined as the percentage of participants with a postvaccination NT \>=4 times the LLOQ if the baseline titer (before vaccination) was below the LLOQ; or a \>=4-fold rise from baseline if the baseline titer was\>=LLOQ. 95% CI was based on Clopper-Pearson method.
Outcome measures
| Measure |
Placebo
n=126 Participants
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
RSVpreF 120 mcg
n=249 Participants
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
|---|---|---|
|
Seroresponse Rates of Neutralizing Titers (NTs) for RSV A and RSV B at 1 Month After Vaccination
RSV A
|
0.8 Percentage of participants
Interval 0.0 to 4.4
|
81.0 Percentage of participants
Interval 75.6 to 85.7
|
|
Seroresponse Rates of Neutralizing Titers (NTs) for RSV A and RSV B at 1 Month After Vaccination
RSV B
|
0.8 Percentage of participants
Interval 0.0 to 4.3
|
75.9 Percentage of participants
Interval 70.1 to 81.1
|
Adverse Events
RSVpreF 120 mcg
Serious events: 2 serious events
Other events: 100 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RSVpreF 120 mcg
n=251 participants at risk
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
Placebo
n=126 participants at risk
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.79%
1/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Gastrointestinal disorders
Enteritis
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
Other adverse events
| Measure |
RSVpreF 120 mcg
n=251 participants at risk
Participants were administered a single dose of RSVpreF 120 mcg on Day 1 via IM injection.
|
Placebo
n=126 participants at risk
Participants were administered a single dose of placebo on Day 1 via IM injection.
|
|---|---|---|
|
General disorders
Asthenia
|
0.80%
2/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.79%
1/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Vascular disorders
Hypertension
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.00%
0/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
General disorders
Fatigue (FATIGUE)
|
23.1%
58/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
26.2%
33/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
12.4%
31/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
3.2%
4/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
General disorders
Pyrexia (FEVER)
|
0.40%
1/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
1.6%
2/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
General disorders
Swelling (SWELLING)
|
1.6%
4/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.79%
1/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
4.8%
12/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
4.0%
5/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Gastrointestinal disorders
Nausea (NAUSEA)
|
3.6%
9/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
6.3%
8/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
0.00%
0/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.79%
1/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
9.2%
23/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
7.9%
10/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
15.5%
39/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
9.5%
12/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Nervous system disorders
Headache (HEADACHE)
|
12.7%
32/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
11.1%
14/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
|
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
|
2.8%
7/251 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
0.79%
1/126 • All-cause mortality and SAEs: From vaccination on Day 1 up to 2 months after vaccination. Other AEs (non-systematic assessment): From vaccination on Day 1 up to 1 month after vaccination; Local reactions and systemic events (systematic assessment): From Day 1 to Day 7 after vaccination
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all screened participants who received the study intervention in the study.
|
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