Trial Outcomes & Findings for Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children (NCT NCT03387137)
NCT ID: NCT03387137
Last Updated: 2024-12-11
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 IV 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 21 and Table 22 in the protocol document.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
Measured through Day 10
Results posted on
2024-12-11
Participant Flow
Participants were recruited from pediatric practices and clinics in the greater Baltimore/Washington area based on referral by the primary care provider or the provider's staff; and through mailing IRB-approved documents to children of local pediatric practices and clinics, and to households in local zip codes containing age-appropriate children between September 2017 and September 2019. The first participant was enrolled on 10/13/2017 and the last participant was enrolled on 9/27/2019.
Of the 73 participants that were screened, 45 met eligibility criteria, parent agreed to enroll and were inoculated with study product.
Participant milestones
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
Group 2: RSV 6120/∆NS2/1030s Vaccine
RSV-seronegative infants and children will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 2: Placebo
RSV-seronegative infants and children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
20
|
10
|
|
Overall Study
COMPLETED
|
10
|
5
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
Baseline characteristics by cohort
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=10 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
Group 2: RSV 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seronegative infants and children will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 2: Placebo
n=10 Participants
RSV-seronegative infants and children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 1 year of age
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Customized
1 year of age
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Customized
2 years of age
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Customized
3 years of age
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Customized
4 years of age
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Customized
> 4 years 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 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
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
20 participants
n=5 Participants
|
10 participants
n=4 Participants
|
45 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 10Population: 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 IV 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 21 and Table 22 in the protocol document.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=10 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Fever · Did not have this AE
|
8 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
LRI in the absence of RSV shedding · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
LRI in the absence of RSV shedding · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Fever · Grade 2
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Fever · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Fever · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Fever · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Upper Respiratory Illness (URI) · Did not have this AE
|
6 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Upper Respiratory Illness (URI) · Grade 1
|
4 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Upper Respiratory Illness (URI) · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Upper Respiratory Illness (URI) · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Upper Respiratory Illness (URI) · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Did not have this AE
|
10 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
LRI in the absence of RSV shedding · Did not have this AE
|
9 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
LRI in the absence of RSV shedding · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
LRI in the absence of RSV shedding · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Cough without LRI · Did not have this AE
|
9 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Cough without LRI · Grade 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Cough without LRI · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Cough without LRI · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Cough without LRI · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Otitis Media · Did not have this AE
|
10 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Otitis Media · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Otitis Media · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Otitis Media · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
Otitis Media · Grade 4
|
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.
Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined by Appendix IV in 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 21 and Table 22 in the protocol document.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=10 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Did not have this AE
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
LRI in the absence of RSV shedding · Did not have this AE
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
LRI in the absence of RSV shedding · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
LRI in the absence of RSV shedding · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Otitis Media · Did not have this AE
|
19 Participants
|
10 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Otitis Media · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Fever · Did not have this AE
|
14 Participants
|
8 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Fever · Grade 1
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Fever · Grade 2
|
4 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Fever · Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Fever · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Upper Respiratory Illness (URI) · Did not have this AE
|
2 Participants
|
6 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Upper Respiratory Illness (URI) · Grade 1
|
18 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Upper Respiratory Illness (URI) · Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Upper Respiratory Illness (URI) · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Upper Respiratory Illness (URI) · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
LRI in the absence of RSV shedding · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
LRI in the absence of RSV shedding · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Cough, without LRI · Did not have this AE
|
14 Participants
|
9 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Cough, without LRI · Grade 1
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Cough, without LRI · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Cough, without LRI · Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Cough, without LRI · Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Otitis Media · Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Otitis Media · Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
Otitis Media · Grade 3
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 10Population: 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 6120/∆NS2/1030s Vaccine
n=10 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seropositive Participants)
|
3 Participants
|
1 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 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=10 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seronegative Participants)
|
9 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: 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 6120/∆NS2/1030s Vaccine
n=10 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 56Population: Study participants who received inoculation and were followed on study pst 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 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=10 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative 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.
As defined as 1) vaccine virus identified in a nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) and/or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 28.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=10 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Subjects)
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 56As defined as 1) vaccine virus identified in a nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) and/or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=10 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Subjects)
|
20 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 4, 5, 6, 7 and 10Population: 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 culture. Only participants who met the definition of infection with vaccine virus were included.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=2 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Peak Titer of Vaccine Virus Shed Measured by Culture (RSV-seropositive Subjects)
|
1.2 log 10 PFU/mL
Standard Deviation 0.5
|
—
|
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 4, 5, 6, 7 and 10Population: 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 reverse transcription polymerase chain reaction (RT-PCR). Only participants who met the definition of infection with vaccine virus were included.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=2 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Peak Titer of Vaccine Virus Shed Measured by Reverse Transcription Polymerase Chain Reaction (RSV-seropositive Subjects)
|
3.1 log 10 copies/mL
Standard Deviation 0.9
|
—
|
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 4, 5, 6, 7 and 10. Last day positive is reported.Population: Only participants who met the definition of infection with vaccine virus were included.
As determined by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=2 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seropositive Subjects)
RT-PCR Positive
|
7.5 Days
Interval 5.0 to 10.0
|
—
|
|
Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seropositive Subjects)
Culture Positive
|
7.5 Days
Interval 5.0 to 10.0
|
—
|
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28Population: 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 culture. Only participants who met the definition of infection with vaccine virus were included.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Peak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Subjects)
|
3.0 log 10 PFU/mL
Standard Deviation 0.8
|
—
|
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28Population: 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 reverse transcription polymerase chain reaction (RT-PCR). Only participants who met the definition of infection with vaccine virus were included.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RSV-seronegative Subjects)
|
4.5 log 10 copies/mL
Standard Deviation 0.8
|
—
|
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28. Lat day positive is reportedPopulation: Only participants who met the definition of infection with vaccine virus were included.
As determined by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seronegative Subjects)
Culture Positive
|
10.2 Days
Interval 7.0 to 14.0
|
—
|
|
Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seronegative Subjects)
RT-PCR Positive
|
11.8 Days
Interval 7.0 to 17.0
|
—
|
PRIMARY outcome
Timeframe: Measured at Day 0 and Day 28Population: Study participants who received inoculation and were followed on study past Day 0 were included.
Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). 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 6120/∆NS2/1030s Vaccine
n=10 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein(RSV-seropositive Subjects)
Serum RSV Neutralizing Antibody Titers
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein(RSV-seropositive Subjects)
Serum IgG ELISA RSV F Antibody Interpolated Titers
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 0 and Day 56Population: Study participants who received inoculation and were followed on study past Day 0 were included.
Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). 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 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=10 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein (RSV-seronegative Subjects)
Serum RSV Neutralizing Antibody Titers
|
18 Participants
|
0 Participants
|
|
Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein (RSV-seronegative Subjects)
Serum IgG ELISA RSV F Antibody Interpolated Titers
|
17 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 28Population: Study participants who received inoculation and were followed on study past Day 0 were included.
Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Serum antibody titers to RSV F glycoprotein were assessed by ELISA.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=10 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA)(RSV-seropositive Subjects)
Serum RSV Neutralizing Antibody Titers
|
7.1 log 2 titers
Standard Deviation 1.0
|
7.2 log 2 titers
Standard Deviation 0.7
|
|
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA)(RSV-seropositive Subjects)
Serum IgG ELISA RSV F Antibody Interpolated Titers
|
12.1 log 2 titers
Standard Deviation 1.5
|
12.9 log 2 titers
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Measured at Day 56Population: Study participants who received inoculation and were followed on study past Day 0 were included.
Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Serum antibody titers to RSV F glycoprotein were assessed by ELISA.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=20 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=10 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
RSV-neutralizing Serum Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) (RSV-seronegative Subjects)
Serum RSV Neutralizing Antibody Titers
|
6.5 log 2 titers
Standard Deviation 1.1
|
2.6 log 2 titers
Standard Deviation 0.6
|
|
RSV-neutralizing Serum Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) (RSV-seronegative Subjects)
Serum IgG ELISA RSV F Antibody Interpolated Titers
|
10.9 log 2 titers
Standard Deviation 1.7
|
6.0 log 2 titers
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enrolled in the study.Population: Only participants who had RSV detected in nasal washes or had greater than or equal to 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Four vaccinees and 2 placebo recipients were excluded due to SARS CoV-2 pandemic and no post-surveillance sample.
As defined as 1) RSV identified in a nasal wash (a binary outcome based on nasal washes done throughout the RSV surveillance period; or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer or Serum IgG RSV F antibody titer from pre- to post-RSV Surveillance season
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=16 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=8 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enroll in the study.Population: Only participants who had RSV detected in nasal washes or had greater than or equal to 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Four vaccinees and 2 placebo recipients were excluded due to SARS CoV-2 pandemic and no post-surveillance sample.
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 washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=6 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Frequency of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enroll in the studyPopulation: Only participants who had RSV detected in nasal washes or had greater than or equal to 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Four vaccinees and 2 placebo recipients were excluded due to SARS CoV-2 pandemic and no post-surveillance sample.
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 washes collected during illness visits for MAARI events or a \> 4-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 MAARI category, and that was 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 21 and Table 22 in the protocol document.Assessed by protocol-determined grading system
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=6 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Fever · Grade 3
|
2 Participants
|
1 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended LRI · Grade 2
|
2 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended LRI · Grade 3
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended LRI · Grade 4
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Cough · No adverse event
|
3 Participants
|
2 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Cough · Grade 1
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Cough · Grade 2
|
3 Participants
|
3 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Cough · Grade 3
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Cough · Grade 4
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Otitis Media · No adverse event
|
4 Participants
|
4 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Otitis Media · Grade 1
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Otitis Media · Grade 2
|
2 Participants
|
1 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Otitis Media · Grade 3
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Otitis Media · Grade 4
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Fever · No adverse event
|
3 Participants
|
3 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Fever · Grade 1
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Fever · Grade 2
|
1 Participants
|
1 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended Fever · Grade 4
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended URI · No adverse event
|
2 Participants
|
1 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended URI · Grade 1
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended URI · Grade 2
|
4 Participants
|
4 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended URI · Grade 3
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended URI · Grade 4
|
0 Participants
|
0 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended LRI · No adverse event
|
4 Participants
|
5 Participants
|
|
Severity of Symptomatic, Medically Attended Respiratory and Febrile Illness in the RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
Medically Attended LRI · Grade 1
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured pre- RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline)Population: Only participants who had RSV detected in nasal washes or had greater than or equal to 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Four vaccinees and 3 placebo recipients were excluded due to SARS CoV-2 pandemic and no post-surveillance sample.
Antibodies were assessed by RSV-neutralizing Antibody and Enzyme-linked Immunosorbent Assay (ELISA). A response was defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre- and post-RSV Surveillance time points.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=6 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=4 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Serum RSV-neutralizing Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in Subjects (RSV-seronegative) Infected With wt RSV During the RSV Surveillance
Pre-RSV Surveillance Serum RSV Neutralizing Antibody
|
6.7 log 2 titers
Standard Deviation 1.4
|
3.0 log 2 titers
Standard Deviation 0.8
|
|
Serum RSV-neutralizing Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in Subjects (RSV-seronegative) Infected With wt RSV During the RSV Surveillance
Post-RSV Surveillance Serum RSV Neutralizing Antibody
|
10.7 log 2 titers
Standard Deviation 1.7
|
8.1 log 2 titers
Standard Deviation 1.0
|
|
Serum RSV-neutralizing Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in Subjects (RSV-seronegative) Infected With wt RSV During the RSV Surveillance
Pre-RSV Surveillance Serum IgG ELISA RSV F Antibody Interpolated Titers
|
10.2 log 2 titers
Standard Deviation 1.9
|
5.4 log 2 titers
Standard Deviation 1.7
|
|
Serum RSV-neutralizing Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in Subjects (RSV-seronegative) Infected With wt RSV During the RSV Surveillance
Post-RSV Surveillance Serum IgG ELISA RSV F Antibody Interpolated Titers
|
14.3 log 2 titers
Standard Deviation 1.4
|
11.8 log 2 titers
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Measured pre-RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline)Population: Only participants who had RSV detected in nasal washes or had greater than or equal to 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Four vaccinees and 3 placebo recipients were excluded due to SARS CoV-2 pandemic and no post-surveillance sample.
Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-RSV surveillance and post-RSV surveillance time points 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 washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=6 Participants
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=4 Participants
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|
|
Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein in RSV-seronegative Subjects (Group 2) Infected With wt RSV During the RSV Surveillance
Serum RSV Neutralizing Antibody
|
5 Participants
|
4 Participants
|
|
Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein in RSV-seronegative Subjects (Group 2) Infected With wt RSV During the RSV Surveillance
Serum IgG ELISA RSV F Antibody Interpolated Titers
|
6 Participants
|
4 Participants
|
Adverse Events
Group 1: RSV 6120/∆NS2/1030s Vaccine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 1: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2: RSV 6120/∆NS2/1030s Vaccine
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Group 2: Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: RSV 6120/∆NS2/1030s Vaccine
n=10 participants at risk
RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 1: Placebo
n=5 participants at risk
RSV-seropositive children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
Group 2: RSV 6120/∆NS2/1030s Vaccine
n=20 participants at risk
RSV-seronegative infants and children will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).
RSV 6120/∆NS2/1030s: Delivered as nose drops
|
Group 2: Placebo
n=10 participants at risk
RSV-seronegative infants and children will receive a single dose of placebo at study entry (Day 0).
Placebo: Delivered as nose drops
|
|---|---|---|---|---|
|
Eye disorders
Eye Discharge
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Diarrhea
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Stomatitis
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
General Discomfort
|
10.0%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
|
10.0%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
15.0%
3/20 • Number of events 5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Pyrexia
|
20.0%
2/10 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 16 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
60.0%
6/10 • Number of events 6 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Bronchiolitis
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Croup
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
25.0%
5/20 • Number of events 8 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
30.0%
3/10 • Number of events 7 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Pharyngitis
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Pneumonia
|
10.0%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
|
10.0%
1/10 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 14 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
90.0%
9/10 • Number of events 10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Epistaxis
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
1/5 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
|
10.0%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
15.0%
3/20 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Rales
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Rhinorrhoea
|
40.0%
4/10 • Number of events 5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
1/5 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
95.0%
19/20 • Number of events 38 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
80.0%
8/10 • Number of events 16 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Rhonchi
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 2 months for Group 1 and between 6 and 10 months for Group 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%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
Wheezing
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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 3 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
1/10 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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
|
0.00%
0/10 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
0/5 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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.
|
15.0%
3/20 • Number of events 3 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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%
2/10 • Number of events 2 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 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: (410) 614-1880
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place