Trial Outcomes & Findings for Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age (NCT NCT03916185)
NCT ID: NCT03916185
Last Updated: 2025-02-21
Results Overview
Solicited adverse events include fever, otitis media, upper respiratory illness (URI), and lower respiratory illness (LRI) and are graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited AEs with at least mild severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Day 0 through Day 28
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
7
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
7
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Moved
|
1
|
0
|
0
|
1
|
|
Overall Study
Not Able to Get to Clinic
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
Baseline characteristics by cohort
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=20 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.4 Months
n=5 Participants
|
14.6 Months
n=7 Participants
|
16.5 Months
n=5 Participants
|
12.3 Months
n=4 Participants
|
13.3 Months
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
51 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
HIV Exposure (from maternal HIV status)
Not HIV Exposed
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
HIV Exposure (from maternal HIV status)
HIV Exposed
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 28Population: All participants who received study product
Solicited adverse events include fever, otitis media, upper respiratory illness (URI), and lower respiratory illness (LRI) and are graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited AEs with at least mild severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=20 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Percentage With Grade 1 or Higher Solicited Adverse Events (AEs)
|
55 percentage of participants
Interval 32.0 to 77.0
|
40 percentage of participants
Interval 19.0 to 64.0
|
71 percentage of participants
Interval 29.0 to 96.0
|
55 percentage of participants
Interval 32.0 to 77.0
|
PRIMARY outcome
Timeframe: Day 0 through Day 28Population: All participants who received study product
LRIs graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited LRIs with at least moderate severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=20 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Percentage With Grade 2 or Higher Lower Respiratory Illnesses (LRIs)
|
5 percentage of participants
Interval 0.0 to 25.0
|
0 percentage of participants
Interval 0.0 to 17.0
|
0 percentage of participants
Interval 0.0 to 41.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
PRIMARY outcome
Timeframe: Day 0 through Day 56Population: All participants who received study product
Serious adverse events are defined according to Version 2.0 of the DAIDS EAE Manual. A serious event is one that requires or lengthens hospitalization, that is life-threatening, that results in death, that results in a significant disability, or that is a congenital anomaly or birth defect. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=20 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Percentage With Serious AEs
|
0 percentage of participants
Interval 0.0 to 17.0
|
0 percentage of participants
Interval 0.0 to 17.0
|
0 percentage of participants
Interval 0.0 to 41.0
|
0 percentage of participants
Interval 0.0 to 17.0
|
PRIMARY outcome
Timeframe: Measured at pre-study product administration (screening) through Day 56Population: Participants with samples available at baseline and Day 56, with Day 56 Visit in the protocol-defined visit window, and one participant randomly selected from households with more than one child enrolled on the same date
Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-study product administration and Day 56 time points. Percentage with 95% exact confidence intervals (CIs) using the Clopper-Pearson method were calculated. The upper limit of the CI was compared to an a priori limit of 70%. An upper limit above 70% was considered a good vaccine candidate.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=17 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=17 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Percentage With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer
|
76 percentage of participants
Interval 50.0 to 93.0
|
71 percentage of participants
Interval 44.0 to 90.0
|
71 percentage of participants
Interval 29.0 to 96.0
|
15 percentage of participants
Interval 3.0 to 38.0
|
SECONDARY outcome
Timeframe: Measured at pre-study product administration (screening) and Day 56Population: Participants with samples available at baseline and Day 56, with Day 56 Visit in the protocol-defined visit window, and one participant randomly selected from households with more than one child enrolled on the same date
RSV F IgG responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-study product administration and Day 56 time points. Percentage with 95% exact CIs using the Clopper-Pearson method were calculated. The upper limit of the CI was compared to an a priori level of 70%. An upper limit above 70% was considered a good vaccine candidate.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=17 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=17 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Percentage With a Greater Than or Equal to 4-fold Rise in Serum RSV F Immunoglobulin G (IgG)
|
88 percentage of participants
Interval 64.0 to 99.0
|
76 percentage of participants
Interval 50.0 to 93.0
|
100 percentage of participants
Interval 59.0 to 100.0
|
15 percentage of participants
Interval 3.0 to 38.0
|
SECONDARY outcome
Timeframe: Measured at the Day 56 VisitPopulation: Participants with a Day 56 sample available, with the Day 56 visit in the protocol-defined visit window, and one participant randomly selected from households with more than one child enrolled on the same date
Serum F IgG antibodies were assessed by Enzyme-linked Immunosorbent Assay (ELISA). Titers below the limit of detection (1:50) were assigned a value equal to half the corresponding limit of detection (1:25) and evaluated as reciprocals of the titer (log2).
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=17 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=17 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Titer of Serum RSV F IgG
|
12.0 log 2 titers
Interval 11.0 to 12.5
|
12.0 log 2 titers
Interval 10.7 to 12.4
|
14.3 log 2 titers
Interval 12.6 to 15.5
|
4.6 log 2 titers
Interval 4.6 to 8.4
|
SECONDARY outcome
Timeframe: Measured at the Day 56 VisitPopulation: Participants with a Day 56 sample available, with the Day 56 visit in the protocol-defined visit window, and one participant randomly selected from households with more than one child enrolled on the same date
Serum RSV-neutralizing antibody titers were assessed by RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Titers below the limit of detection (1:10) were assigned a value equal to half the corresponding limit of detection (1:5) and evaluated as reciprocals of the titer (log2).
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=17 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=17 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Titer of Serum RSV-neutralizing Antibodies
|
6.2 log 2 titers
Interval 4.3 to 7.3
|
5.1 log 2 titers
Interval 4.5 to 6.3
|
7.7 log 2 titers
Interval 6.5 to 9.3
|
2.3 log 2 titers
Interval 2.3 to 3.4
|
SECONDARY outcome
Timeframe: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the studyPopulation: Participants with follow up during an RSV season
The percentage and 95% exact Clopper-Pearson CI of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wild type (wt) RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAARI events or through site reporting. RSV-associated upper respiratory tract illness, lower respiratory tract illness, otitis media, or fever were graded following a protocol-defined grading system.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=19 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Percentage With RSV-associated Medically Attended Acute Respiratory Illness (RSV-MAARI)
|
11 percentage of participants
Interval 1.0 to 33.0
|
15 percentage of participants
Interval 3.0 to 38.0
|
0 percentage of participants
Interval 0.0 to 41.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the studyPopulation: Participants with follow up during an RSV season
The number of participants who had RSV-MAARI among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAARI events or through site reporting. A participant was only counted once in the line corresponding to the highest grade MAARI event they experienced. These events were graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=19 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAARI
Grade 2
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAARI
No RSV-MAARI
|
17 Participants
|
17 Participants
|
7 Participants
|
19 Participants
|
|
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAARI
Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the studyPopulation: Participants will follow up during an RSV season
The percentage and 95% exact Clopper-Pearson CI of participants who had RSV-associated, symptomatic, medically attended acute lower respiratory tract illness (MAALRI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAALRI events or through site reporting. RSV-associated lower respiratory tract illness graded following a protocol-defined grading system.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=19 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Percentage With RSV-associated Medically Attended Acute Lower Respiratory Illness (RSV-MAALRI)
|
5 percentage of participants
Interval 0.0 to 26.0
|
0 percentage of participants
Interval 0.0 to 17.0
|
0 percentage of participants
Interval 0.0 to 41.0
|
0 percentage of participants
Interval 0.0 to 17.0
|
SECONDARY outcome
Timeframe: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the studyPopulation: Participants with follow up during an RSV season
The number of participants who had RSV-MAALRI among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAALRI events or through site reporting. A participant was only counted once in the line corresponding to the highest grade MAALRI event they experienced. These events were graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Outcome measures
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=19 Participants
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 Participants
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 Participants
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 Participants
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAALRI
Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAALRI
No RSV-MAALRI
|
18 Participants
|
20 Participants
|
7 Participants
|
20 Participants
|
|
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAALRI
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
RSV ΔNS2/Δ1313/I1314L Vaccine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
RSV 6120/ΔNS2/1030s Vaccine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
RSV 276 Vaccine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RSV ΔNS2/Δ1313/I1314L Vaccine
n=20 participants at risk
Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV ΔNS2/Δ1313/I1314L Vaccine: 10\^6 plaque-forming units (PFU); administered as nose drops
|
RSV 6120/ΔNS2/1030s Vaccine
n=20 participants at risk
Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
RSV 276 Vaccine
n=7 participants at risk
Participants received a single dose of the RSV 276 vaccine at study entry (Day 0).
RSV 276 Vaccine: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Placebo
n=20 participants at risk
Participants received a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Eye disorders
Eye discharge
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Eye disorders
Lacrimation increased
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Gastrointestinal disorders
Dental caries
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Gastrointestinal disorders
Lip swelling
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
14.3%
1/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
10.0%
2/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
General disorders
Developmental delay
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
General disorders
Pyrexia
|
20.0%
4/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
25.0%
5/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
71.4%
5/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
40.0%
8/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
General disorders
Swelling face
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Adenovirus infection
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Bronchiolitis
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Croup infectious
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Gingivitis
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Otitis media
|
15.0%
3/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
15.0%
3/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
57.1%
4/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
10.0%
2/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
14.3%
1/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Tooth abscess
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
30.0%
6/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
25.0%
5/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
28.6%
2/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
10.0%
2/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Investigations
Cardiac murmur
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
15.0%
3/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Nervous system disorders
Infant irritability
|
10.0%
2/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
10.0%
2/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
5/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
28.6%
2/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
30.0%
6/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
14.3%
1/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
2/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
50.0%
10/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
50.0%
10/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
71.4%
5/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
45.0%
9/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
14.3%
1/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
0.00%
0/7 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
5.0%
1/20 • 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season
All adverse events collected through Day 28. All serious AEs collected through Day 56. From Day 56 to RSV Season only serious and unexpected suspected adverse reactions (SUSARs) collected. During RSV season only medically attended fevers, LRIs, URIs, and otitis media, as well as all serious AEs collected. At the Post-RSV season visit, only SUSARs and grade 3 or higher AEs related to visit procedures collected.
|
Additional Information
IMPAACT Clinicaltrials.gov Coordinator
Family Health International (FHI 360)
Phone: (919) 405-1429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place