Trial Outcomes & Findings for Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children (NCT NCT03596801)
NCT ID: NCT03596801
Last Updated: 2026-02-13
Results Overview
Solicited adverse events (AE's) 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 20 and 21 in the protocol document.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Measured through Day 10
Results posted on
2026-02-13
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 April 2018 and October 2023. The first participant was enrolled on 06/29/2018 and the last participant was enrolled on 10/20/2023.
Of the 100 participants that were screened, 60 met eligibility criteria, parent agreed to enroll and were inoculated with study product.
Participant milestones
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
Group 2: RSV 6120/∆NS1 Vaccine
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 2: RSV 6120/F1/G2/∆NS1
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 2: Placebo
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
5
|
14
|
14
|
7
|
|
Overall Study
COMPLETED
|
10
|
10
|
5
|
14
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children
Baseline characteristics by cohort
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
Group 2: RSV 6120/∆NS1 Vaccine
n=14 Participants
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 2: RSV 6120/F1/G2/∆NS1
n=14 Participants
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 2: Placebo
n=7 Participants
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
< 1 year of age
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=1267 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=122 Participants
|
10 Participants
n=122 Participants
|
|
Age, Customized
1 year of age
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
10 Participants
n=1267 Participants
|
11 Participants
n=15 Participants
|
4 Participants
n=122 Participants
|
28 Participants
n=122 Participants
|
|
Age, Customized
2 years of age
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
8 Participants
n=122 Participants
|
|
Age, Customized
3 years of age
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
6 Participants
n=122 Participants
|
|
Age, Customized
4 years of age
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
8 Participants
n=122 Participants
|
|
Age, Customized
>4 years of age
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=122 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=12 Participants
|
8 Participants
n=1267 Participants
|
8 Participants
n=15 Participants
|
3 Participants
n=122 Participants
|
31 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
6 Participants
n=1267 Participants
|
6 Participants
n=15 Participants
|
4 Participants
n=122 Participants
|
29 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
3 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
4 Participants
n=12 Participants
|
13 Participants
n=1267 Participants
|
14 Participants
n=15 Participants
|
7 Participants
n=122 Participants
|
57 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=122 Participants
|
5 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
4 Participants
n=12 Participants
|
8 Participants
n=1267 Participants
|
12 Participants
n=15 Participants
|
4 Participants
n=122 Participants
|
42 Participants
n=122 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=1267 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=122 Participants
|
12 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=122 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=6 Participants
|
10 participants
n=6 Participants
|
5 participants
n=12 Participants
|
14 participants
n=1267 Participants
|
14 participants
n=15 Participants
|
7 participants
n=122 Participants
|
60 participants
n=122 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 10Population: Study participants who were immunized were included.
Solicited adverse events (AE's) 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 20 and 21 in the protocol document.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Upper Respiratory Illness (URI) · Grade 2*
|
0 Participants
|
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
|
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
|
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
|
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 3*
|
0 Participants
|
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
|
0 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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Fever · Did not have this AE
|
10 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Fever · Grade 1*
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Fever · Grade 2*
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Fever · Grade 3*
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Fever · Grade 4*
|
0 Participants
|
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
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Upper Respiratory Illness (URI) · Grade 1*
|
3 Participants
|
3 Participants
|
0 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
|
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
|
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
|
10 Participants
|
10 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*
|
0 Participants
|
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
|
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
|
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
|
8 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Cough without LRI · Grade 1*
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Cough without LRI · Grade 2*
|
0 Participants
|
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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Cough without LRI · Grade 4*
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Otitis Media · Did not have this AE
|
9 Participants
|
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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Otitis Media · Grade 2*
|
1 Participants
|
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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)
Otitis Media · Grade 4*
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase.
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 20 and Table 21 in the protocol document.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=13 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=14 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=6 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Fever · Did not have this AE*
|
10 Participants
|
12 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Fever · Grade 1*
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Fever · Grade 2*
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Fever · Grade 3*
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Fever · Grade 4*
|
0 Participants
|
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*
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Upper Respiratory Illness (URI) · Grade 1*
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Upper Respiratory Illness (URI) · Grade 2*
|
0 Participants
|
1 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
|
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
|
0 Participants
|
|
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*
|
13 Participants
|
14 Participants
|
6 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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Lower Respiratory Illness (LRI) with RSV shedding · Grade 2*
|
0 Participants
|
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
|
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
|
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*
|
13 Participants
|
14 Participants
|
6 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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
LRI in the absence of RSV shedding · Grade 2*
|
0 Participants
|
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 3*
|
0 Participants
|
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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Cough without LRI · Did not have this AE*
|
10 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Cough without LRI · Grade 1*
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Cough without LRI · Grade 2*
|
0 Participants
|
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
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Cough without LRI · Grade 4*
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Otitis Media · Did not have this AE*
|
13 Participants
|
14 Participants
|
6 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Otitis Media · Grade 1*
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Otitis Media · Grade 2*
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Otitis Media · Grade 3*
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)
Otitis Media · Grade 4*
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 10Population: Study participants who were immunized 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/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Number of Participants With Unsolicited AEs (RSV-seropositive Participants)
|
3 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase.
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/∆NS1 Vaccine
n=13 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=14 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=6 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Number of Participants With Unsolicited AEs (RSV-seronegative Participants)
|
3 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who were immunized 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 above.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 56Population: Study participants who received were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens during the acute phase.
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 above.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=13 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=14 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=6 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who were immunized were included.
Defined as 1) vaccine virus identified in nasal wash (a binary outcome based on nasal washes or done throughout the study period; Day 0 nasal wash will be counted as baseline) or 2) a greater than or equal to 4-fold rise in serum RSV neutralizing antibody titer or serum RSV F (IgG) titer from study entry to Study Day 28.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Participants)
Vaccine virus shedding by culture or qPCR
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Participants)
Serum RSV Neutralizing Antibody Titers
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Participants)
Serum IgG ELISA RSV F Antibody Interpolated Titers
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 56Population: Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase.
Defined as 1) vaccine virus identified in nasal wash or nasal swab (a binary outcome based on nasal washes or nasal swabs done throughout the study period; Day 0 nasal wash or nasal swabs will be counted as baseline) or 2) a greater than or equal to 4-fold rise in serum RSV neutralizing antibody titer or serum RSV F (IgG) titer from study entry to Study Day 56.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=13 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=14 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=6 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Participants)
Vaccine virus shedding by culture/PCR
|
10 Participants
|
9 Participants
|
0 Participants
|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Participants)
Serum RSV Neutralizing Antibody Titers
|
7 Participants
|
11 Participants
|
0 Participants
|
|
Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Participants)
Serum IgG ELISA RSV F Antibody Interpolated Titers
|
8 Participants
|
10 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured at Days 0,3,4,5,6,7 and 10.Population: Study participants who were immunized were included. 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
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28Population: Study participants who were immunized were included. Data from one Group 2 RSV 6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens during the acute phase.
This is the mean of the highest value per participant of the titer of vaccine virus (peak titer) shed measured by culture from all samples collected during the acute phase. Only participants who met the definition of infection with vaccine virus were included.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=9 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Peak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Participants)
|
1.4 log 10 PFU/mL
Standard Deviation 0.9
|
1.2 log 10 PFU/mL
Standard Deviation 0.6
|
—
|
PRIMARY outcome
Timeframe: Measured at Days 0, 3, 4, 5, 6, 7 and 10Population: Study participants who were immunized were included. Virus shedding was not detected by culture or qPCR.
As determined by a) culture and b) reverse transcription polymerase chain reaction (rRT-PCR)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at Days 0,3,5,7,10,12,14,17 and 28. Last day positive is reported.Population: Study participants who were immunized were included. Only participants who met the definition of infection with vaccine virus were included. Data from one Group 2 RSV 6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase.
As determined by a) culture and/or b) qPCR. Only the participants who met the definition of infection with vaccine virus were included.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=9 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Duration of Virus Shedding in Nasal Washes or Nasal Swabs (RSV-seronegative Participants)
Culture Positive
|
9.8 Days
Interval 3.0 to 14.0
|
10.3 Days
Interval 4.0 to 12.0
|
—
|
|
Duration of Virus Shedding in Nasal Washes or Nasal Swabs (RSV-seronegative Participants)
qPCR
|
13.0 Days
Interval 3.0 to 17.0
|
13.9 Days
Interval 4.0 to 16.0
|
—
|
PRIMARY outcome
Timeframe: Measured at Day 0 and Day 28Population: Study participants who were immunized were included.
Serum RSV-neutralizing antibody titers were assessed through an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater 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/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at 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 Participants)
Serum RSV Neutralizing Antibody Titers
|
0 Participants
|
1 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 Participants)
Serum IgG ELISA RSV F Antibody Interpolated Titers*
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 56Population: Study participants who were immunized were included. Data from one Group2 RSV 6120/DNS1 vaccinee and one placebo recipient excluded from analysis because wild-type (wt) -RSV was detected in nasal specimens collected during the acute phase.
As defined as a greater than or equal to 4-fold rise in RSV Neutralizing Antibody Titer and/or Serum 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/∆NS1 Vaccine
n=13 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=14 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=6 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at 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 Participants)
Serum RSV Neutralizing Antibody Titers
|
7 Participants
|
11 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 Participants)
Serum IgG ELISA RSV F Antibody Interpolated TIters*
|
8 Participants
|
10 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Day 28Population: Study participants who were immunized were included.
Serum RSV-neutralizing antibody titers to RSV F glycoprotein were assessed by glycoprotein Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined a 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/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
RSV-Neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seropositive Participants)
Serum RSV Neutralizing Antibody Titers (pre inoculation)
|
8.5 log 2 titers
Standard Deviation 2.2
|
6.8 log 2 titers
Standard Deviation 1.1
|
7.7 log 2 titers
Standard Deviation 1.5
|
|
RSV-Neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seropositive Participants)
Serum RSV Neutralizing Antibody Titers (post inoculation)
|
7.7 log 2 titers
Standard Deviation 2.0
|
7.1 log 2 titers
Standard Deviation 1.1
|
7.1 log 2 titers
Standard Deviation 1.3
|
|
RSV-Neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seropositive Participants)
Serum IgG ELISA RSV F Antibody *Interpolated Titers (pre-inoculation)
|
14.9 log 2 titers
Standard Deviation 1.7
|
13.6 log 2 titers
Standard Deviation 1.3
|
14.1 log 2 titers
Standard Deviation 1.2
|
|
RSV-Neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seropositive Participants)
Serum IgG ELISA RSV F Antibody Interpolated Titers (post inoculation)
|
14.6 log 2 titers
Standard Deviation 1.7
|
13.9 log 2 titers
Standard Deviation 1.3
|
14.1 log 2 titers
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Measured through Day 56Population: Study participants who were immunized were included. Data from one Group 2 RSV/6120/DNS1 vaccinee and one placebo recipient are excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase.
Serum Antibody Titers to RSV F Glycoprotein were assessed by Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer paired specimens, between pre-inoculation and post-inoculation time points.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=13 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=14 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=6 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seronegative Participants)
Serum RSV Neutralizing Antibody Titers (pre inoculation)
|
2.6 log 2 titers
Standard Deviation 0.8
|
2.7 log 2 titers
Standard Deviation 0.9
|
2.7 log 2 titers
Standard Deviation 0.9
|
|
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seronegative Participants)
Serum RSV Neutralizing Antibody Titers (post inoculation)
|
4.6 log 2 titers
Standard Deviation 1.7
|
5.9 log 2 titers
Standard Deviation 1.9
|
2.3 log 2 titers
Standard Deviation 0.0
|
|
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seronegative Participants)
Serum IgG ELISA RSV F Antibody *Interpolated Titers (pre inoculation)
|
11.2 log 2 titers
Standard Deviation 2.6
|
11.0 log 2 titers
Standard Deviation 2.6
|
10.7 log 2 titers
Standard Deviation 2.9
|
|
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Antibody Responses to RSV F Glycoprotein (RSV-seronegative Participants)
Serum IgG ELISA RSV F Antibody *Interpolated Titers (post inoculation)
|
15.6 log 2 titers
Standard Deviation 2.8
|
16.1 log 2 titers
Standard Deviation 2.2
|
10.0 log 2 titers
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Day 0 through the 28th day following inoculationPopulation: Study participants who were immunized were included
Lower respiratory tract illness (LRI) is a Solicited Adverse Event (AE) as defined in Appendix IV of the protocol document. LRI includes: wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi, rales. The number of participants who experienced LRI was presented.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
The Frequency of Study-related Product Lower Respiratory Tract Illness (LRIs) in RSV-seropositive Participants.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the studyPopulation: Participants who had RSV detected in nasal specimens or had \> or = to 4-fold rise in serum antibodies pre-to post-RSV season in absence of RSV-associated medical events were included. 6 RSV 6120/∆NS1 vaccinees, 4 6120/F1/G2/∆NS1 vaccinees and 2 placebo recipients were excluded due to SARS-CoV-2 pandemic \& no post-surveillance sample.1 Group 2 RSV 6120/DNS1 vaccinee and 1 placebo recipient were excluded from analysis because wt-RSV was detected in nasal specimens collected during the acute phase.
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/swabs collected during illness visits for MAARI- events, or a greater than 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/∆NS1 Vaccine
n=2 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=4 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=3 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at 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 RSV Season
|
1 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the studyPopulation: Participants who had RSV detected in nasal specimens or had \>or= to 4-fold rise in serum antibodies pre-to post-RSV season in absence of RSV-associated medical events were included. 6 RSV 6120/DNS1 vaccinees, 4 RSV 6120/F1/G2/DNS1 vaccinees \& 2 placebo recipients were excluded due to SARS-CoV-2 pandemic \& no post-surveillance sample. 1 Group 2 RSV 6120/DNS1 vaccinee \&1 placebo recipients were excluded from analysis because wt-RSV was detected in nasal specimens collected during the acute phase.
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 specimens collected during illness visits for MAARI events or a 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. 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 20 and 21 in the protocol document. Assessed by protocol -determined grading system.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=1 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=4 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=2 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at 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 RSV Season.
Medically Attended URI · Did not have MAARI*
|
0 Participants
|
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 RSV Season.
Medically Attended URI · Grade 1*
|
0 Participants
|
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 RSV Season.
Medically Attended URI · Grade 2*
|
1 Participants
|
4 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 RSV Season.
Medically Attended URI · Grade 3*
|
0 Participants
|
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 RSV Season.
Medically Attended URI · Grade 4*
|
0 Participants
|
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 RSV Season.
Medically Attended Cough · Did not have MAARI*
|
0 Participants
|
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 RSV Season.
Medically Attended Cough · Grade 1*
|
0 Participants
|
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 RSV Season.
Medically Attended Cough · Grade 2*
|
1 Participants
|
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 RSV Season.
Medically Attended Cough · Grade 3*
|
0 Participants
|
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 RSV Season.
Medically Attended Cough · Grade 4*
|
0 Participants
|
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 RSV Season.
Medically Attended Otitis Media · Did not have MAARI*
|
0 Participants
|
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 RSV Season.
Medically Attended Otitis Media · Grade 1*
|
0 Participants
|
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 RSV Season.
Medically Attended Otitis Media · Grade 2*
|
1 Participants
|
2 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 RSV Season.
Medically Attended Otitis Media · Grade 3*
|
0 Participants
|
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 RSV Season.
Medically Attended Otitis Media · Grade 4*
|
0 Participants
|
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 RSV Season.
Medically Attended LRI · Did not have MAARI*
|
1 Participants
|
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 RSV Season.
Medically Attended Fever · Did not have MAARI*
|
0 Participants
|
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 RSV Season.
Medically Attended Fever · Grade 1*
|
0 Participants
|
0 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 RSV Season.
Medically Attended Fever · Grade 2*
|
1 Participants
|
1 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 RSV Season.
Medically Attended Fever · Grade 3*
|
0 Participants
|
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 RSV Season.
Medically Attended Fever · Grade 4*
|
0 Participants
|
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 RSV Season.
Medically Attended LRI · Grade 1*
|
0 Participants
|
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 RSV Season.
Medically Attended LRI · Grade 2*
|
0 Participants
|
1 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 RSV Season.
Medically Attended LRI · Grade 3*
|
0 Participants
|
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 RSV Season.
Medically Attended LRI · Grade 4*
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the studyPopulation: Participants who had RSV detected in nasal specimens or had \>or= to 4-fold rise in serum antibodies pre-to post- RSV season in the absence of RSV-associated medical events were included. 6 RSV 6120/DNS1, 5 RSV 6120/F1/G2/DNS1 \& 2 placebo recipients were excluded due to SARS-CoV-2 pandemic \& no post-surveillance sample. 1 Group 2 RSV 6120/DNS1 vaccinee and 1 placebo recipient were excluded from analysis because wt-RSV was detected in nasal specimens collected during the acute phase of the study.
The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators onf 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 specimens collected during illness visits for MAARI events or a 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.
Outcome measures
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=2 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=3 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=3 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Serum RSV Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in RSV Seronegative Subjects (Group 2) Infected With Wt-RSV During the RSV Surveillance.
Pre-Surveillance Serum IgG ELISA RSV F Antibody *Interpolated Titers
|
17.7 log 2 titers
Standard Deviation 0.9
|
15.0 log 2 titers
Standard Deviation 2.7
|
10.5 log 2 titers
Standard Deviation 2.3
|
|
Serum RSV Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in RSV Seronegative Subjects (Group 2) Infected With Wt-RSV During the RSV Surveillance.
Pre-Surveillance Serum RSV Neutralizing Antibody*
|
6.7 log 2 titers
Standard Deviation 0.0
|
4.7 log 2 titers
Standard Deviation 2.5
|
2.3 log 2 titers
Standard Deviation 0.0
|
|
Serum RSV Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in RSV Seronegative Subjects (Group 2) Infected With Wt-RSV During the RSV Surveillance.
Post-RSV Surveillance Serum RSV Neutralizing Antibody*
|
8.6 log 2 titers
Standard Deviation 3.7
|
8.4 log 2 titers
Standard Deviation 2.8
|
4.7 log 2 titers
Standard Deviation 0.9
|
|
Serum RSV Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in RSV Seronegative Subjects (Group 2) Infected With Wt-RSV During the RSV Surveillance.
Post-RSV Surveillance Serum IgG ELISA RSV F Antibody *Interpolated Titers
|
20.5 log 2 titers
Standard Deviation 0.3
|
18.0 log 2 titers
Standard Deviation 1.6
|
18.2 log 2 titers
Standard Deviation 1.2
|
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 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. Six RSV 6120/DNS1, 5 RSV 6120/DNS1/F1/G2, 2 placebo recipients were excluded due to no post-surveillance serum sample due to SARS-CoV-2. One Group 2 RSV 6120/DNS1vaccinee and one placebo recipient were excluded from analysis because wild-type (wt)-RSV was detected in nasal specimens collected during the acute phase.
Serum RSV-neutralizing antibody titers and Serum IgG 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 specimens 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/∆NS1 Vaccine
n=2 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=3 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=3 Participants
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|
|
Number of Participants With 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 Neutralizing Antibody
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With 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
|
2 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Group 1: RSV 6120/∆NS1 Vaccine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 1: RSV 6120/F1/G2/∆NS1 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/∆NS1 Vaccine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 2: RSV 6120/F1/G2/∆NS1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: RSV 6120/∆NS1 Vaccine
n=10 participants at risk
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
n=10 participants at risk
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 1: Placebo
n=5 participants at risk；n=10 participants at risk
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
Group 2: RSV 6120/∆NS1 Vaccine
n=13 participants at risk
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0.
RSV 6120/∆NS1: Delivered as nose drops
|
Group 2: RSV 6120/F1/G2/∆NS1
n=14 participants at risk
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
RSV 6120/F1/G2/∆NS1: Delivered as nose drops
|
Group 2: Placebo
n=6 participants at risk
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0.
Placebo: Delivered as nose drops
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
30.0%
3/10 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
53.8%
7/13 • Number of events 15 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
64.3%
9/14 • Number of events 15 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
66.7%
4/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
Respiratory, thoracic and mediastinal disorders
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/14 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
46.2%
6/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
42.9%
6/14 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
16.7%
1/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
15.4%
2/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
14.3%
2/14 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
Infections and infestations
Otitis Media
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
23.1%
3/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
28.6%
4/14 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
33.3%
2/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
General disorders
Pyrexia
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
61.5%
8/13 • Number of events 13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
35.7%
5/14 • Number of events 9 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
33.3%
2/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
14.3%
2/14 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
15.4%
2/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/14 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
7.1%
1/14 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1, and between 6 and 10 months for Group 2 depending on time of enrollment.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/13 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
7.1%
1/14 • Number of events 1 • From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1, and between 6 and 10 months for Group 2 depending on time of enrollment.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
0.00%
0/6 • 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.
Group 1 Day 0-28 all SAEs \& Day 0-10, Group 2 Day 0-56 all SAEs and Day 0-28 all Solicited AEs and Unsolicited AEs, exceptions as per protocol Section 8. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. After Day 56 for Group 2, from Nov 1- Mar 31 of the following year, medically attended fever, LRI, URI and otitis media were collected. Data from 1 Group 2 RSV 6120/DNS1 \& 1 placebo recipient are excluded related to detection of wt-RSV during the acute phase.
|
Additional Information
Ruth A. Karron, MD
Johns Hopkins Bloomberg School of Public Health (JHSPH)
Phone: 410-614-0319
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place