Trial Outcomes & Findings for Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age (NCT NCT04520659)
NCT ID: NCT04520659
Last Updated: 2025-08-22
Results Overview
Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix III of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document. Details regarding LRIs will be noted in Primary Outcome Measure #2.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
81 participants
Primary outcome timeframe
Measured through Day 28
Results posted on
2025-08-22
Participant Flow
Participants were recruited from pediatric practices and clinics in the greater Baltimore, MD/Washington, DC, Rochester, NY and Nashville, TN areas based on referral by the primary care provider or the provider's staff; and through electronic patient portals using IRB-approved messages. These recruitment methods targeted age-appropriate children between February, 2022 and March, 2023. The first participant was enrolled on 3/16/22 and the last participant was enrolled on 5/10/23.
Of the 111 participants that were screened, 81 met eligibility criteria and the parent agreed to enroll their child. The 81 children were then inoculated with study product.
Participant milestones
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
Acute Phase (Days 0-28)
STARTED
|
14
|
7
|
40
|
20
|
|
Acute Phase (Days 0-28)
COMPLETED
|
14
|
7
|
40
|
20
|
|
Acute Phase (Days 0-28)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
RSV Surveillance Phase Oct. 16-March 31
STARTED
|
14
|
7
|
40
|
20
|
|
RSV Surveillance Phase Oct. 16-March 31
COMPLETED
|
13
|
7
|
39
|
20
|
|
RSV Surveillance Phase Oct. 16-March 31
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|
|
RSV Surveillance Phase Oct. 16-March 31
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age
Baseline characteristics by cohort
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=7 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=40 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=20 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 6 months of age
|
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
|
|
Age, Customized
6-12 months of age
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Age, Customized
13-18 months of age
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Customized
19-24 months of age
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Age, Customized
> 24 months of age
|
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
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 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
|
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)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
40 participants
n=5 Participants
|
20 participants
n=4 Participants
|
81 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who received inoculation and were followed on study past Day 0 were included.
Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix III of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document. Details regarding LRIs will be noted in Primary Outcome Measure #2.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=7 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=40 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=20 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=54 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=27 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Fever · Did not have this AE
|
14 Participants
|
7 Participants
|
27 Participants
|
11 Participants
|
41 Participants
|
18 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Fever · Grade 1
|
0 Participants
|
0 Participants
|
8 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Fever · Grade 2
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Fever · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Fever · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Upper Respiratory · Did not have this AE
|
4 Participants
|
4 Participants
|
13 Participants
|
12 Participants
|
17 Participants
|
16 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Otitis media · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Upper Respiratory · Grade 1
|
9 Participants
|
3 Participants
|
24 Participants
|
7 Participants
|
33 Participants
|
10 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Upper Respiratory · Grade 2
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Upper Respiratory · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Upper Respiratory · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Lower Respiratory Illness (LRI) with RSV shedding · Did not have this AE
|
14 Participants
|
7 Participants
|
39 Participants
|
20 Participants
|
53 Participants
|
27 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Lower Respiratory Illness (LRI) with RSV shedding · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Lower Respiratory Illness (LRI) with RSV shedding · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Lower Respiratory Illness (LRI) with RSV shedding · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Lower Respiratory Illness (LRI) with RSV shedding · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
LRI in the absence of RSV shedding · Did not have this AE
|
14 Participants
|
7 Participants
|
40 Participants
|
20 Participants
|
54 Participants
|
27 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
LRI in the absence of RSV shedding · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
LRI in the absence of RSV shedding · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
LRI in the absence of RSV shedding · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
LRI in the absence of RSV shedding · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Cough without LRI · Did not have this AE
|
11 Participants
|
6 Participants
|
29 Participants
|
16 Participants
|
40 Participants
|
22 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Cough without LRI · Grade 1
|
2 Participants
|
0 Participants
|
9 Participants
|
3 Participants
|
11 Participants
|
3 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Cough without LRI · Grade 2
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Cough without LRI · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Cough without LRI · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Otitis media · Did not have this AE
|
14 Participants
|
7 Participants
|
37 Participants
|
18 Participants
|
51 Participants
|
25 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Otitis media · Grade 2
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Otitis media · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Otitis media · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who received inoculation and were followed on study past Day 0 were included.
LRI may include wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi and rales as defined in Appendix III of the protocol document. A participant was only counted once in each LRI category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=7 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=40 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=20 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=54 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=27 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rales · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rales · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rales · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Wheezing · Did not have this LRI
|
14 Participants
|
7 Participants
|
40 Participants
|
20 Participants
|
54 Participants
|
27 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Wheezing · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Wheezing · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Wheezing · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Wheezing · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Pneumonia · Did not have this LRI
|
14 Participants
|
7 Participants
|
40 Participants
|
20 Participants
|
54 Participants
|
27 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Pneumonia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Pneumonia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Pneumonia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Pneumonia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Laryngotracheobronchitis (Croup) · Did not have this LRI
|
14 Participants
|
7 Participants
|
39 Participants
|
20 Participants
|
53 Participants
|
27 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Laryngotracheobronchitis (Croup) · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Laryngotracheobronchitis (Croup) · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Laryngotracheobronchitis (Croup) · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Laryngotracheobronchitis (Croup) · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rhonchi · Did not have this LRI
|
14 Participants
|
7 Participants
|
40 Participants
|
20 Participants
|
54 Participants
|
27 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rhonchi · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rhonchi · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rhonchi · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rhonchi · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rales · Did not have this LRI
|
14 Participants
|
7 Participants
|
40 Participants
|
20 Participants
|
54 Participants
|
27 Participants
|
|
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Rales · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who received inoculation and were followed on study past Day 0 were included.
Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=7 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=40 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=20 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=54 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=27 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Urinary tract infection · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Nasal Congestion · Did not have this
|
14 Participants
|
6 Participants
|
29 Participants
|
18 Participants
|
43 Participants
|
24 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Nasal Congestion · Grade 1
|
0 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Nasal Congestion · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Nasal Congestion · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Nasal Congestion · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Emesis · Did not have this
|
12 Participants
|
7 Participants
|
37 Participants
|
20 Participants
|
49 Participants
|
27 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Emesis · Grade 1
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Emesis · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Emesis · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Emesis · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Diarrhea · Did not have this
|
13 Participants
|
6 Participants
|
37 Participants
|
19 Participants
|
50 Participants
|
25 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Diarrhea · Grade 1
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Diarrhea · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Diarrhea · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Diarrhea · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Conjunctivitis · Did not have this
|
12 Participants
|
7 Participants
|
40 Participants
|
19 Participants
|
52 Participants
|
26 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Conjunctivitis · Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Conjunctivitis · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Conjunctivitis · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Conjunctivitis · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Pain · Did not have this
|
14 Participants
|
6 Participants
|
40 Participants
|
19 Participants
|
54 Participants
|
25 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Pain · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Pain · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Pain · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Pain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Rash · Did not have this
|
13 Participants
|
7 Participants
|
39 Participants
|
19 Participants
|
52 Participants
|
26 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Rash · Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Rash · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Rash · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Rash · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Urinary tract infection · Did not have this
|
14 Participants
|
7 Participants
|
39 Participants
|
20 Participants
|
53 Participants
|
27 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Urinary tract infection · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Urinary tract infection · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Urinary tract infection · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured Day 0 through Day 56 after inoculation and During the RSV Surveillance Season (Date of seasonal pause in enrollment in year of inoculation through March 31)Population: Study participants who received inoculation and were followed on study past Day 0 were included.
A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: Results in death during the period of protocol-defined surveillance; Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; Results in a persistent or significant disability/incapacity; Is a congenital anomaly or birth defect, OR Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=7 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=40 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=20 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=54 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=27 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 0 and Day 56Population: Study participants who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included. One study participant in Group 2 withdrew prior to the Day 56 serum collection and is not included in this analysis.
Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=39 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=53 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer
|
12 Participants
|
26 Participants
|
38 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at Days 5, 7, 10, 12 and additional illness visits between Days 0 and 28.Population: Only participants who met the definition of infection with vaccine virus were included.
This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by RT-qPCR. Group 1 participants only. Only participants who met the definition of infection with vaccine virus were included.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only)
|
6.6 log 10 copies/mL
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Day 56Population: Study participants in Group 1 who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included.
Defined as shedding vaccine virus, detected by RT-qPCR, and/or ≥4-fold rise in RSV-specific serum antibodies, detected by enzyme-linked immunosorbent assay (ELISA) against the RSV F protein and/or an RSV-PRNT from study entry to Study Day 56
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Number of Vaccinees Infected With RSV Vaccine Virus in Group 1
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31)Population: Only participants who had RSV detected in nasal swabs or had \> 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Two vaccinees were excluded due to withdrawing prior to the completing the RSV surveillance period, and one placebo recipient was excluded due to parent refused to allow collection of the post-surveillance serum sample. Medically Attended Lower Respiratory Illness will be detailed in Secondary Outcome #9
The number 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 wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal swabs collected during illness visits for MAARI events or a \> 2.5-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=13 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=5 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=27 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=11 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=40 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=16 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Fever · Did not have this MAARI
|
8 Participants
|
4 Participants
|
15 Participants
|
7 Participants
|
23 Participants
|
11 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Fever · Grade 1
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Fever · Grade 2
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Fever · Grade 3
|
5 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Fever · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Upper Respiratory Illness · Did not have this MAARI
|
6 Participants
|
2 Participants
|
12 Participants
|
4 Participants
|
18 Participants
|
6 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Upper Respiratory Illness · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Upper Respiratory Illness · Grade 2
|
7 Participants
|
3 Participants
|
15 Participants
|
5 Participants
|
22 Participants
|
8 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Upper Respiratory Illness · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Upper Respiratory Illness · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Lower Respiratory Illness with RSV · Did not have this MAARI
|
11 Participants
|
5 Participants
|
26 Participants
|
10 Participants
|
37 Participants
|
15 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Lower Respiratory Illness with RSV · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Lower Respiratory Illness with RSV · Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Lower Respiratory Illness with RSV · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Lower Respiratory Illness with RSV · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
LRI in the absence of RSV · Did not have this MAARI
|
11 Participants
|
5 Participants
|
25 Participants
|
11 Participants
|
36 Participants
|
16 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
LRI in the absence of RSV · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
LRI in the absence of RSV · Grade 2
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
LRI in the absence of RSV · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
LRI in the absence of RSV · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Cough without LRI · Did not have this MAARI
|
8 Participants
|
2 Participants
|
12 Participants
|
5 Participants
|
20 Participants
|
7 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Cough without LRI · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Cough without LRI · Grade 2
|
5 Participants
|
2 Participants
|
15 Participants
|
5 Participants
|
20 Participants
|
7 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Cough without LRI · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Cough without LRI · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Otitis media · Did not have this MAARI
|
8 Participants
|
5 Participants
|
16 Participants
|
8 Participants
|
24 Participants
|
13 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Otitis media · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Otitis media · Grade 2
|
5 Participants
|
0 Participants
|
11 Participants
|
3 Participants
|
16 Participants
|
3 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Otitis media · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Otitis media · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31)Population: Only participants who had RSV detected in nasal swabs or had \> 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Two vaccinees were excluded due to withdrawing prior to the completing the RSV surveillance period, and one placebo recipient was excluded due to parent refused to allow collection of the post-surveillance serum sample.
The number of participants who had RSV-associated, symptomatic, medically attended acute lower respiratory 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 was defined as having either RSV detected in nasal swabs collected during illness visits for MAALRI events or a ≥ 2.5-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each LRI category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=13 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=5 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=27 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=11 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=40 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=16 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Wheezing · Did not have this MAALRI
|
12 Participants
|
5 Participants
|
26 Participants
|
11 Participants
|
38 Participants
|
16 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Wheezing · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Wheezing · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Wheezing · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Wheezing · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Pneumonia · Did not have this MAALRI
|
12 Participants
|
5 Participants
|
26 Participants
|
11 Participants
|
38 Participants
|
16 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Pneumonia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Pneumonia · Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Pneumonia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Pneumonia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchitis · Did not have this MAALRI
|
12 Participants
|
5 Participants
|
27 Participants
|
11 Participants
|
39 Participants
|
16 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchitis · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchitis · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchitis · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchitis · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
laryngotracheobronchitis (Croup) · Did not have this MAALRI
|
11 Participants
|
5 Participants
|
26 Participants
|
11 Participants
|
37 Participants
|
16 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
laryngotracheobronchitis (Croup) · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
laryngotracheobronchitis (Croup) · Grade 2
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
laryngotracheobronchitis (Croup) · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
laryngotracheobronchitis (Croup) · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rhonchi · Did not have this MAALRI
|
13 Participants
|
5 Participants
|
27 Participants
|
11 Participants
|
40 Participants
|
16 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rhonchi · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rhonchi · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rhonchi · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rhonchi · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rales · Did not have this MAALRI
|
13 Participants
|
5 Participants
|
26 Participants
|
11 Participants
|
39 Participants
|
16 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rales · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rales · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rales · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Rales · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchiolitis · Did not have this MAALRI
|
13 Participants
|
5 Participants
|
27 Participants
|
10 Participants
|
40 Participants
|
15 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchiolitis · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchiolitis · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchiolitis · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season
Bronchiolitis · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Day 0 and Day 56Population: Study participants who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included. One study participant in Group 2 withdrew prior to the Day 56 serum collection and is not included in this analysis.
Serum RSV preF IgG titers and RSV postF IgG titers were assessed by an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a ≥4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.
Outcome measures
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=39 Participants
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=53 Participants
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG
RSV PreF IgG
|
9 Participants
|
22 Participants
|
31 Participants
|
—
|
—
|
—
|
|
Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG
RSV PostF IgG
|
12 Participants
|
28 Participants
|
40 Participants
|
—
|
—
|
—
|
Adverse Events
Group 1: RSV LID/ΔM2-2/1030s
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 1: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: RSV LID/ΔM2-2/1030s
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Group 2: Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Groups 1 and 2 Combined: Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 participants at risk
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=7 participants at risk
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=40 participants at risk；n=60 participants at risk
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=20 participants at risk
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=54 participants at risk；n=74 participants at risk
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=27 participants at risk
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/60 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/20 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
1.4%
1/74 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/27 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
Other adverse events
| Measure |
Group 1: RSV LID/ΔM2-2/1030s
n=14 participants at risk
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 1: Placebo
n=7 participants at risk
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Group 2: RSV LID/ΔM2-2/1030s
n=40 participants at risk；n=60 participants at risk
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Group 2: Placebo
n=20 participants at risk
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s
n=54 participants at risk；n=74 participants at risk
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops
|
Groups 1 and 2 Combined: Placebo
n=27 participants at risk
Participants will receive a single dose of placebo at study entry (Day 0).
Placebo: Administered as nose drops
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
14.3%
1/7 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
7.5%
3/40 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
5.0%
1/20 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
7.4%
4/54 • Number of events 4 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
7.4%
2/27 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 4 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
7.5%
3/40 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/20 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
9.3%
5/54 • Number of events 7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/27 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
General disorders
Fever
|
0.00%
0/14 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
32.5%
13/40 • Number of events 16 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
45.0%
9/20 • Number of events 13 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
24.1%
13/54 • Number of events 16 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
33.3%
9/27 • Number of events 13 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
General disorders
Pain
|
0.00%
0/14 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
14.3%
1/7 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/40 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
5.0%
1/20 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/54 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
7.4%
2/27 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Infections and infestations
Conjunctivitis
|
14.3%
2/14 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/40 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
5.0%
1/20 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
3.7%
2/54 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
3.7%
1/27 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Infections and infestations
Otitis media
|
0.00%
0/14 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
7.5%
3/40 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
10.0%
2/20 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
5.6%
3/54 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
7.4%
2/27 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/14 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
2.5%
1/40 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/20 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
1.9%
1/54 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/27 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
14.3%
1/7 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
27.5%
11/40 • Number of events 14 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
20.0%
4/20 • Number of events 6 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
25.9%
14/54 • Number of events 17 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
18.5%
5/27 • Number of events 7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Croup
|
0.00%
0/14 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
2.5%
1/40 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/20 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
1.9%
1/54 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/27 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
14.3%
1/7 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
27.5%
11/40 • Number of events 13 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
10.0%
2/20 • Number of events 4 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
20.4%
11/54 • Number of events 13 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
11.1%
3/27 • Number of events 5 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
71.4%
10/14 • Number of events 15 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
42.9%
3/7 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
67.5%
27/40 • Number of events 36 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
40.0%
8/20 • Number of events 10 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
68.5%
37/54 • Number of events 51 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
40.7%
11/27 • Number of events 13 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
0.00%
0/7 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
2.5%
1/40 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
5.0%
1/20 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
3.7%
2/54 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
3.7%
1/27 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
|
Additional Information
Suzanne Woods, CRNP-P, CCRP, Manager, RSVPeds Team
Johns Hopkins University Bloomberg School of Public Health
Phone: (443) 813-0697
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place