Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults (NCT NCT03572062)
NCT ID: NCT03572062
Last Updated: 2021-08-26
Results Overview
Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than \[\>\] 21). 1 measuring device unit = 0.5 centimeter (cm) and graded as: mild (2.5 to 5.0 cm), moderate (greater than \[\>\] 5.0 to 10.0 cm), and severe (\>10 cm). Pain at injection site was graded as: mild (did not interfere with activity), moderate (interferes with activity) and severe (prevented daily activity).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
317 participants
Primary outcome timeframe
Within 14 days after Vaccination 1
Results posted on
2021-08-26
Participant Flow
This study was conducted in 2 Cohorts: Primary Cohort (Single administration of RSVpreF formulations or placebo, co-administered with seasonal inactivated influenza vaccine \[SIIV\]), and Month-0, Month-2 Cohort (two doses of an RSVpreF formulation or placebo administered two months apart).
Participant milestones
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
Month-0, Month-2 Cohort: Placebo
Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
31
|
32
|
32
|
32
|
31
|
32
|
31
|
|
Overall Study
Treated
|
32
|
32
|
32
|
31
|
31
|
30
|
32
|
30
|
32
|
31
|
|
Overall Study
COMPLETED
|
32
|
32
|
32
|
31
|
31
|
28
|
31
|
30
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
4
|
1
|
1
|
32
|
31
|
Reasons for withdrawal
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
Month-0, Month-2 Cohort: Placebo
Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
No Longer Meets Eligibility Criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
29
|
27
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Randomized But Not Treated
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
Baseline characteristics by cohort
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=30 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 Participants
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
Month-0, Month-2 Cohort: Placebo
n=31 Participants
Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Mean
|
71.2 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
71.4 years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
70.2 years
STANDARD_DEVIATION 3.5 • n=8 Participants
|
70.4 years
STANDARD_DEVIATION 5.4 • n=8 Participants
|
70.8 years
STANDARD_DEVIATION 4.5 • n=24 Participants
|
72.2 years
STANDARD_DEVIATION 4.4 • n=42 Participants
|
72.6 years
STANDARD_DEVIATION 5.4 • n=42 Participants
|
71.2 years
STANDARD_DEVIATION 4.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
145 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
168 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
312 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
31 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
285 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 14 days after Vaccination 1Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Primary cohort only.
Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than \[\>\] 21). 1 measuring device unit = 0.5 centimeter (cm) and graded as: mild (2.5 to 5.0 cm), moderate (greater than \[\>\] 5.0 to 10.0 cm), and severe (\>10 cm). Pain at injection site was graded as: mild (did not interfere with activity), moderate (interferes with activity) and severe (prevented daily activity).
Outcome measures
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=30 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 Participants
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
|---|---|---|---|---|---|---|---|---|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Pain at Injection Site: Mild
|
32.3 percentage of participants
Interval 16.7 to 51.4
|
28.1 percentage of participants
Interval 13.7 to 46.7
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
22.6 percentage of participants
Interval 9.6 to 41.1
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
18.8 percentage of participants
Interval 7.2 to 36.4
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Pain at Injection Site: Moderate
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Pain at Injection Site: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Redness: Mild
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.6
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Redness: Moderate
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.6
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Swelling: Mild
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Redness: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Swelling: Moderate
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1
Swelling: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
PRIMARY outcome
Timeframe: Within 14 days after Vaccination 1Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Primary cohort only.
Systemic events included fever, fatigue/tiredness, headache, vomiting, nausea, diarrhea, muscle pain and joint pain recorded by participants in an e-diary. Fever was graded as: mild (38.0 to 38.4 degrees \[deg\] Celsius \[C\]), moderate (38.5 to 38.9 deg C), severe (39 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle 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 (1-2 times in 24 hours \[h\]), moderate (\>2 times in 24h) and severe (required intravenous hydration). Diarrhea was graded as: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h) and severe (6 or more loose stools in 24h).
Outcome measures
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=30 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 Participants
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
|---|---|---|---|---|---|---|---|---|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Fever: Grade 4
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Nausea: Mild
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
0 percentage of participants
Interval 0.0 to 11.6
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Nausea: Moderate
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Nausea: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Fever: Mild
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Fever: Moderate
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Fever: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Vomiting: Mild
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Vomiting: Moderate
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Vomiting: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
00 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Diarrhea: Mild
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.2
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Diarrhea: Moderate
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Diarrhea: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Headache: Mild
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
25.0 percentage of participants
Interval 11.5 to 43.4
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Headache: Moderate
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
0 percentage of participants
Interval 0.0 to 10.9
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.6
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Headache: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
FatigueTtiredness: Mild
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
15.6 percentage of participants
Interval 5.3 to 32.8
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
31.3 percentage of participants
Interval 16.1 to 50.0
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Fatigue/Tiredness: Moderate
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
18.8 percentage of participants
Interval 7.2 to 36.4
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Fatigue/Tiredness: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Joint Pain: Mild
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 10.9
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.2
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Muscle Pain: Mild
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
12.9 percentage of participants
Interval 3.6 to 29.8
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
12.5 percentage of participants
Interval 3.5 to 29.0
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Muscle Pain: Moderate
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Muscle Pain: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Joint Pain: Moderate
|
0 percentage of participants
Interval 0.0 to 11.2
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
|
Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1
Joint Pain: Severe
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 11.6
|
0 percentage of participants
Interval 0.0 to 10.9
|
0 percentage of participants
Interval 0.0 to 11.6
|
PRIMARY outcome
Timeframe: Within 1 month after Vaccination 1Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Data for this outcome measure was planned to be collected for Primary cohort only.
An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=30 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 Participants
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
|---|---|---|---|---|---|---|---|---|
|
Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
|
21.9 percentage of participants
Interval 9.3 to 40.0
|
21.9 percentage of participants
Interval 9.3 to 40.0
|
34.4 percentage of participants
Interval 18.6 to 53.2
|
29.0 percentage of participants
Interval 14.2 to 48.0
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
21.9 percentage of participants
Interval 9.3 to 40.0
|
16.7 percentage of participants
Interval 5.6 to 34.7
|
PRIMARY outcome
Timeframe: Up to 12 months after Vaccination 1Population: Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1. Data for this outcome measure was planned to be collected for Primary cohort only.
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE is any untoward medical occurrence at any dose: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Outcome measures
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=30 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 Participants
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
|---|---|---|---|---|---|---|---|---|
|
Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1
MAEs
|
46.9 percentage of participants
Interval 29.1 to 65.3
|
59.4 percentage of participants
Interval 40.6 to 76.3
|
46.9 percentage of participants
Interval 29.1 to 65.3
|
51.6 percentage of participants
Interval 33.1 to 69.8
|
54.8 percentage of participants
Interval 36.0 to 72.7
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
50.0 percentage of participants
Interval 31.9 to 68.1
|
50.0 percentage of participants
Interval 31.3 to 68.7
|
|
Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1
SAEs
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
12.5 percentage of participants
Interval 3.5 to 29.0
|
12.5 percentage of participants
Interval 3.5 to 29.0
|
12.9 percentage of participants
Interval 3.6 to 29.8
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
12.5 percentage of participants
Interval 3.5 to 29.0
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
SECONDARY outcome
Timeframe: Before vaccination and 1 Month after Vaccination 1Population: Evaluable immunogenicity population: eligible participants who received both SIIV and RSV vaccinations or SIIV and placebo as randomized, had blood drawn within 27-42 days after Visit 1 pre-specified time frames at 1-month post-vaccination follow-up visit, had at least 1 valid, determinate assay result for proposed analysis, had no major protocol violations. Number Analyzed= participants evaluable for each row. Data for this outcome measure was planned to be collected for Primary cohort only.
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. Titers above the lower limit of quantitation (LLOQ) were considered accurate and their quantitated values were reported. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5 × LLOQ.
Outcome measures
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=29 Participants
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=29 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 Participants
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
|---|---|---|---|---|---|---|---|---|
|
Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
RSV A: Before Vaccination 1
|
2113 titers
Interval 1610.6 to 2772.5
|
2592 titers
Interval 1932.3 to 3477.8
|
2234 titers
Interval 1591.1 to 3136.5
|
2395 titers
Interval 1817.9 to 3155.4
|
2333 titers
Interval 1779.8 to 3057.1
|
2061 titers
Interval 1600.2 to 2653.4
|
2243 titers
Interval 1696.4 to 2966.8
|
2093 titers
Interval 1509.0 to 2903.8
|
|
Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
RSV A: 1 Month After Vaccination 1
|
15158 titers
Interval 10503.8 to 21875.0
|
12385 titers
Interval 9555.6 to 16051.2
|
17806 titers
Interval 12893.3 to 24590.4
|
15492 titers
Interval 11012.7 to 21793.6
|
18045 titers
Interval 12589.5 to 25865.5
|
23929 titers
Interval 18242.8 to 31386.8
|
23833 titers
Interval 17799.2 to 31912.0
|
1823 titers
Interval 1376.5 to 2415.2
|
|
Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
RSV B: Before Vaccination 1
|
1786 titers
Interval 1383.3 to 2305.3
|
2116 titers
Interval 1526.7 to 2933.7
|
1728 titers
Interval 1271.9 to 2346.4
|
2021 titers
Interval 1451.8 to 2812.2
|
1884 titers
Interval 1337.0 to 2655.9
|
1844 titers
Interval 1417.5 to 2398.8
|
1580 titers
Interval 1210.9 to 2061.1
|
1677 titers
Interval 1156.2 to 2433.0
|
|
Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1
RSV B: 1 Month After Vaccination 1
|
15182 titers
Interval 9785.1 to 23555.6
|
9694 titers
Interval 7396.8 to 12705.8
|
14436 titers
Interval 10196.9 to 20436.9
|
12781 titers
Interval 8571.0 to 19058.7
|
18205 titers
Interval 12574.4 to 26356.6
|
20777 titers
Interval 15034.9 to 28711.0
|
22249 titers
Interval 15715.7 to 31497.5
|
1617 titers
Interval 1139.6 to 2294.9
|
SECONDARY outcome
Timeframe: Before vaccination and 1 Month after Vaccination 1Population: Evaluable immunogenicity population: participants who received both SIIV and RSV vaccinations or SIIV and placebo as randomized, had blood drawn within 27-42 days after Visit 1 pre-specified time frames at 1-month post-vaccination follow-up visit, had at least 1 valid, determinate assay result for analysis, had no major protocol violations. Number Analyzed = participants evaluable for each specified row. Data for this outcome was planned to be collected for Primary cohort only.
The HAI and neutralizing titer LLOQ value for each strain was 1:10. Assay results below the LLOQ were set to 0.5 × LLOQ. The analysis was performed on following strains: H1N1 A/Michigan, H3N2 A/Brisbane, B/Phuket for HAI and H3N2/Brisbane for neutralizing assay.
Outcome measures
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=29 Participants
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=29 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=31 Participants
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 Participants
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
|---|---|---|---|---|---|---|---|---|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
HAI: H1N1 A/Michigan: Before Vaccination 1
|
47.9 titers
Interval 31.69 to 72.26
|
42.8 titers
Interval 27.81 to 65.78
|
29.5 titers
Interval 19.03 to 45.84
|
35.8 titers
Interval 22.14 to 57.77
|
37.2 titers
Interval 22.99 to 60.19
|
31.9 titers
Interval 18.31 to 55.48
|
38.3 titers
Interval 27.2 to 53.8
|
35.4 titers
Interval 20.37 to 61.6
|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
HAI: H1N1 A/Michigan: 1 Month After Vaccination 1
|
121.5 titers
Interval 84.37 to 175.11
|
114.4 titers
Interval 79.95 to 163.6
|
102.1 titers
Interval 69.15 to 150.65
|
141.5 titers
Interval 90.54 to 221.13
|
143.9 titers
Interval 91.81 to 225.51
|
100.4 titers
Interval 74.68 to 134.96
|
118.3 titers
Interval 84.12 to 166.4
|
149.3 titers
Interval 104.93 to 212.4
|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
HAI: H3N2 A/Brisbane: Before Vaccination 1
|
121.6 titers
Interval 67.92 to 217.54
|
143.9 titers
Interval 90.99 to 227.52
|
57.8 titers
Interval 35.11 to 95.19
|
80.9 titers
Interval 53.49 to 122.38
|
102.3 titers
Interval 61.32 to 170.69
|
90.7 titers
Interval 53.21 to 154.57
|
121.7 titers
Interval 87.32 to 169.55
|
76.8 titers
Interval 45.79 to 128.87
|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
HAI: H3N2 A/Brisbane: 1 Month After Vaccination 1
|
297.9 titers
Interval 197.3 to 449.64
|
372.4 titers
Interval 221.98 to 624.7
|
238.9 titers
Interval 167.42 to 340.78
|
251.6 titers
Interval 163.84 to 386.49
|
327.2 titers
Interval 208.41 to 513.8
|
258.1 titers
Interval 174.2 to 382.29
|
286.2 titers
Interval 201.75 to 405.87
|
321.8 titers
Interval 221.41 to 467.83
|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
HAI: B/Phuket: Before Vaccination 1
|
8.7 titers
Interval 6.37 to 11.78
|
8.4 titers
Interval 6.68 to 10.59
|
6.6 titers
Interval 5.61 to 7.82
|
7.9 titers
Interval 6.31 to 9.79
|
8.6 titers
Interval 6.57 to 11.25
|
7.3 titers
Interval 5.55 to 9.69
|
9.1 titers
Interval 6.82 to 12.11
|
7.5 titers
Interval 5.74 to 9.77
|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
HAI: B/Phuket: 1 Month After Vaccination 1
|
12.3 titers
Interval 8.99 to 16.9
|
11.2 titers
Interval 8.41 to 14.92
|
10.2 titers
Interval 8.03 to 13.0
|
12.2 titers
Interval 8.62 to 17.15
|
14.4 titers
Interval 10.31 to 20.05
|
14.7 titers
Interval 10.21 to 21.3
|
15.5 titers
Interval 10.86 to 22.02
|
15.2 titers
Interval 10.25 to 22.68
|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
Neutralizing assay: H3N2/Brisbane: Before Vaccination 1
|
12.4 titers
Interval 9.06 to 16.97
|
15.5 titers
Interval 11.94 to 20.02
|
10.2 titers
Interval 8.09 to 12.9
|
9.3 titers
Interval 7.76 to 11.27
|
12.4 titers
Interval 9.03 to 16.93
|
10.1 titers
Interval 7.84 to 13.06
|
12.2 titers
Interval 10.16 to 14.71
|
8.7 titers
Interval 6.92 to 10.95
|
|
Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1
Neutralizing assay: H3N2/Brisbane: 1 Month After Vaccination 1
|
27.3 titers
Interval 19.24 to 38.7
|
27.4 titers
Interval 18.43 to 40.66
|
19.1 titers
Interval 14.63 to 25.06
|
21.4 titers
Interval 16.08 to 28.44
|
22.1 titers
Interval 16.11 to 30.36
|
21.2 titers
Interval 16.15 to 27.9
|
21.9 titers
Interval 16.82 to 28.44
|
26.7 titers
Interval 18.74 to 38.0
|
Adverse Events
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Primary Cohort: RSVpreF 240 mcg + SIIV
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Primary Cohort: Placebo + SIIV
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Month-0, Month-2 Cohort: Placebo
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 participants at risk
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=30 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 participants at risk
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
Month-0, Month-2 Cohort: Placebo
n=31 participants at risk
Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Chest pain
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma metastatic
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Product Issues
Device breakage
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
Other adverse events
| Measure |
Primary Cohort: RSVpreF 60 mcg + Al(OH)3 + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of respiratory syncytial virus stabilized prefusion F subunit (RSVpreF) 60 microgram (mcg) with aluminum hydroxide (Al\[OH\]3) by injecting 0.5 milliliter (mL) dose along with single 0.5mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 60 mcg + CpG/Al(OH)3 + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 60 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + Al(OH)3 + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 120 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 120 mcg + CpG/Al(OH)3 + SIIV
n=31 participants at risk
Participants were administered an intramuscular dose of RSVpreF 120 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + Al(OH)3 + SIIV
n=31 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg with Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + CpG/Al(OH)3 + SIIV
n=30 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: RSVpreF 240 mcg + SIIV
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Primary Cohort: Placebo + SIIV
n=30 participants at risk
Participants were administered an intramuscular dose of placebo intramuscularly as 0.5-mL injection along with single 0.5 mL intramuscular dose of SIIV on Day 1. Participants were followed-up through Month 12.
|
Month-0, Month-2 Cohort: RSVpreF 240 mcg + CpG/Al(OH)3
n=32 participants at risk
Participants were administered an intramuscular dose of RSVpreF 240 mcg with CpG/Al(OH)3 as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
Month-0, Month-2 Cohort: Placebo
n=31 participants at risk
Participants were administered an intramuscular dose of placebo as 0.5-mL injection on Day 1 Month 0 (Vaccination 1) and Month 2 (Vaccination 2: 54 to 66 Days after Vaccination 1). Participants were followed up through 6 months after Vaccination 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Fatigue
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Fatigue (FATIGUE)
|
21.9%
7/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
18.8%
6/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
28.1%
9/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
29.0%
9/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
19.4%
6/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
13.3%
4/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
43.8%
14/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
20.0%
6/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
37.5%
12/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
41.9%
13/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Influenza like illness
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Injection site erythema
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Injection site erythema (REDNESS)
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.7%
3/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
15.6%
5/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Injection site pain
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
31.2%
10/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
31.2%
10/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
29.0%
9/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
22.6%
7/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
16.7%
5/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
18.8%
6/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
10.0%
3/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
37.5%
12/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
12.9%
4/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Injection site reaction
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Injection site swelling (SWELLING)
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
12.5%
4/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Peripheral swelling
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Pyrexia (FEVER)
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.7%
3/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
General disorders
Vaccination site pain
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
12.5%
4/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
15.6%
5/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.5%
2/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
10.0%
3/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
13.3%
4/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
12.9%
4/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.5%
2/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Nausea (NAUSEA)
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.5%
2/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.7%
3/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
10.0%
3/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
12.9%
4/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
12.9%
4/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Viral infection
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.2%
2/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
15.6%
5/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.5%
2/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.7%
2/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
13.3%
4/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
12.5%
4/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
22.6%
7/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Degenerative bone disease
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
12.9%
4/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
16.1%
5/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
16.7%
5/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
18.8%
6/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
20.0%
6/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
18.8%
6/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
19.4%
6/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.5%
2/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Nervous system disorders
Headache (HEADACHE)
|
18.8%
6/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
9.4%
3/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
19.4%
6/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.5%
2/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
16.7%
5/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
37.5%
12/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
6.7%
2/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
15.6%
5/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
29.0%
9/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.2%
1/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.3%
1/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/30 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
3.1%
1/32 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
0.00%
0/31 • Local reactions and systemic events: within 14 days after vaccination Other AEs: within one month after vaccination; SAEs: Day 1 up to 12 Months for Primary Cohort; Day 1 up to 6 Months for Month-0, Month-2 Cohort
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all participants who received at least 1 dose of the investigational products (RSVpreF or placebo) at Visit 1.
|
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