Trial Outcomes & Findings for A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers (NCT NCT06705140)
NCT ID: NCT06705140
Last Updated: 2026-08-03
Results Overview
An SAE was defined as any AE that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
42 participants
Primary outcome timeframe
From first dose of study vaccine administration (Day 1) to 198 days
Results posted on
2026-08-03
Participant Flow
Study was conducted at 1 center in a single country from 25 November 2024 to 13 December 2024. 42 healthy infants/toddlers aged 6 to\<22 months were randomized to 2 cohorts: preterm born children(Cohort1:randomized to receive either placebo or standard dose of live-attenuated respiratory syncytial virus delta\[Δ\] non-structural \[NS\]2/Δ1313/I1314L vaccine \[RSVt vaccine\]) and full term born children (Cohort2:randomized to receive either low dose, standard dose or high dose RSVt vaccine or placebo).
Cohort 1: Groups 1 and 2 and Cohort 2 initiated enrollment at the same time. However, due to the early study termination (29 days following the first vaccination) as per sponsor's decision (no safety concerns), enrollment in Cohort 1 Groups 3 and 4 did not occur. No participants received the second vaccination.
Participant milestones
| Measure |
Cohort 1: Group 1: Standard Dose RSVt
Participants born after a gestation period of 28 through 36 weeks (pre-term) received standard dose of RSVt vaccine 0.2 milliliter (mL) (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 1: Group 2: Placebo
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 2: Standard Dose RSVt
Participants born after a gestation period of \>=37 weeks (full-term) received standard dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
10
|
10
|
12
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
10
|
10
|
12
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Baseline characteristics by cohort
| Measure |
Cohort 1: Group 1: Standard Dose RSVt
n=2 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received standard dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 2: Standard Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received standard dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
16.5 months
STANDARD_DEVIATION 0.707 • n=20 Participants
|
14.0 months
STANDARD_DEVIATION 5.20 • n=20 Participants
|
13.0 months
STANDARD_DEVIATION 3.71 • n=40 Participants
|
10.9 months
STANDARD_DEVIATION 2.69 • n=6 Participants
|
11.8 months
STANDARD_DEVIATION 3.38 • n=7 Participants
|
10.0 months
STANDARD_DEVIATION 2.12 • n=13 Participants
|
12.0 months
STANDARD_DEVIATION 3.43 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
17 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=13 Participants
|
25 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
10 Participants
n=6 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=13 Participants
|
42 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 85 (28 days post-vaccination 2)Population: As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination. As pre-specified in the statistical analysis plan (SAP), PRNT testing was not conducted, as it was not scientifically justified given the early termination due to the clinical hold. Accordingly, only RSV serum anti-F IgA and anti-F IgG antibody titers at Day 1 are presented, consistent with the pre-specified SAP analyses.
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV A serum neutralizing antibody titers were planned to be determined using a validated plaque reduction neutralization test (PRNT).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 85 (28 days post-vaccination 2)Population: As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination. As pre-specified in the SAP, PRNT testing was not conducted, as it was not scientifically justified given the early termination due to the clinical hold. Accordingly, only RSV serum anti-F IgA and anti-F IgG antibody titers at Day 1 are presented, consistent with the pre-specified SAP analyses.
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV B serum neutralizing antibody titers were planned to be determined using a validated PRNT.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 30 minutes after each vaccination (post-dose on Day 1)Population: Safety analysis set (SafAS) consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination.
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. All participants were observed for 30 minutes after each vaccination and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days after each vaccination (post-dose on Day 1)Population: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination.
A solicited injection/administration site reactions were adverse reactions (AR) at and around the injection/administration site of the study vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Solicited Administration Site Reactions
|
2 Participants
|
0 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 21 days after each vaccination (post-dose on Day 1)Population: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination.
A solicited reaction was an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF and considered as related to the study vaccine administered.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Solicited Systemic Reactions
|
2 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after each vaccination (post-dose on Day 1)Population: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination.
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Unsolicited Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study vaccine administration (Day 1) to 198 daysPopulation: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination.
An MAAE was defined as a new onset or a worsening of a condition that prompted the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Medically Attended Adverse Events (MAAEs)
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study vaccine administration (Day 1) to 198 daysPopulation: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination.
An SAE was defined as any AE that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study vaccine administration (Day 1) to 198 daysPopulation: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination.
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor was appropriate. Acute wheeze and anaphylaxis were collected as AESI.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 85Population: As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination. As pre-specified in the SAP, PRNT testing was not conducted, as it was not scientifically justified given the early termination due to the clinical hold. Accordingly, only RSV serum anti-F IgA and anti-F IgG antibody titers at Day 1 are presented, consistent with the pre-specified SAP analyses.
Serum samples were planned to be collected at specified timepoints for immunogenicity assessments. RSV A and RSV B serum neutralizing antibody titers were planned to be determined using a validated PRNT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 85Population: Full analysis set (FAS) consisted of subset of randomized participants who received at least 1 administration of the study vaccine. Participants did not receive second dose of vaccination as study was terminated. Hence, no samples collected on Day 85.
Serum samples were collected at specified timepoints for immunogenicity assessments. Antibodies to RSV F antigen were measured using the anti-RSV serum anti-F IgA and IgG using electrochemiluminescence method. Log10 titer values are reported.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Mean Titers of RSV Serum Anti-F Immunoglobulin (Ig) A and IgG Antibodies at Baseline (Day 1) and Day 85
Baseline (Day 1): IgA
|
1.45 titer
Standard Deviation 1.52
|
1.20 titer
Standard Deviation 0.622
|
1.35 titer
Standard Deviation 0.881
|
0.502 titer
Standard Deviation 0.364
|
1.56 titer
Standard Deviation 0.953
|
0.921 titer
Standard Deviation 0.863
|
|
Cohorts 1 and 2: Mean Titers of RSV Serum Anti-F Immunoglobulin (Ig) A and IgG Antibodies at Baseline (Day 1) and Day 85
Baseline (Day 1): IgG
|
1.79 titer
Standard Deviation 1.87
|
0.709 titer
Standard Deviation 1.14
|
2.55 titer
Standard Deviation 0.878
|
0.935 titer
Standard Deviation 0.798
|
2.55 titer
Standard Deviation 0.911
|
1.57 titer
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Day 8 and Day 64Population: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination. Hence, no samples collected on Day 64.
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. Quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Percentages rounded off to tenth decimal place.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Percentage of Participants With Quantified Shedding >=3.37 Lower Limit of Quantitation (LLOQ)
Day 8
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 30.8
|
40.0 percentage of participants
Interval 12.2 to 73.8
|
25.0 percentage of participants
Interval 5.5 to 57.2
|
0 percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Day 8 and Day 64Population: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination. Hence, no samples collected on Day 64.
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. qRT-PCR assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Percentages rounded off to tenth decimal place.
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
n=3 Participants
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=2 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=10 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Percentage of Participants With Detectable Shedding >=2.08 Limit of Detection
Day 8
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 30.8
|
50.0 percentage of participants
Interval 18.7 to 81.3
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
0 percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Day 8 and Day 64Population: SafAS consisted of participants who had received at least 1 administration of the study vaccine. As study was terminated 29 days after first vaccination, participants did not receive second dose of vaccination. Hence, no samples collected on Day 64. Only participants with quantified vaccine virus shedding (\>= 3.37 LLOQ) have been reported.
Nasal swabs were collected to assess shedding of the attenuated RSV vaccine strain at specified timepoints. qRT-PCR assay was developed to detect and quantify RSV ΔNS2 candidate in nasal swab samples. Quantified virus shedding was defined as vaccine virus shedding \>=lower limit of quantification (LLOQ=3.37 log10 copies/mL).
Outcome measures
| Measure |
Cohort 1: Group 2: Placebo
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=4 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=3 Participants
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Titer of Vaccine Virus Shedding in Participants Detected in Nasal Samples Quantified by Quantitative Real Time-Polymerase Chain Reaction
Day 8
|
—
|
—
|
—
|
5.20 log10 copies/mL
Standard Deviation 1.02
|
4.91 log10 copies/mL
Standard Deviation 1.33
|
—
|
Adverse Events
Cohort 1: Group 1: Standard Dose RSVt
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1: Group 2: Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Group 1: Low Dose RSVt
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Group 2: Standard Dose RSVt
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2: Group 3: High Dose RSVt
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: Group 4: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Group 1: Standard Dose RSVt
n=2 participants at risk
Participants born after a gestation period of 28 through 36 weeks (pre-term) received standard dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 1: Group 2: Placebo
n=3 participants at risk
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=10 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 2: Standard Dose RSVt
n=10 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received standard dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
33.3%
1/3 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/10 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/10 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/12 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/5 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
Other adverse events
| Measure |
Cohort 1: Group 1: Standard Dose RSVt
n=2 participants at risk
Participants born after a gestation period of 28 through 36 weeks (pre-term) received standard dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 1: Group 2: Placebo
n=3 participants at risk
Participants born after a gestation period of 28 through 36 weeks (pre-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 1: Low Dose RSVt
n=10 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received low dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 2: Standard Dose RSVt
n=10 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received standard dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 3: High Dose RSVt
n=12 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received high dose of RSVt vaccine 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
Cohort 2: Group 4: Placebo
n=5 participants at risk
Participants born after a gestation period of \>=37 weeks (full-term) received placebo 0.2 mL (0.1 mL per nostril) as intranasal administration on Day 1.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
2/10 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
50.0%
5/10 • Number of events 5 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
16.7%
2/12 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
60.0%
3/5 • Number of events 3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
10.0%
1/10 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
30.0%
3/10 • Number of events 3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
16.7%
2/12 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
1/5 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
33.3%
1/3 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
10.0%
1/10 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
2/10 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
16.7%
2/12 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
1/5 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
33.3%
1/3 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
30.0%
3/10 • Number of events 3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
70.0%
7/10 • Number of events 7 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
8.3%
1/12 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
60.0%
3/5 • Number of events 3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
66.7%
2/3 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
60.0%
6/10 • Number of events 6 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
80.0%
8/10 • Number of events 8 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
33.3%
4/12 • Number of events 4 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
40.0%
2/5 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
33.3%
1/3 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
2/10 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
30.0%
3/10 • Number of events 3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
16.7%
2/12 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
1/5 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
General disorders
Crying
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
2/10 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
40.0%
4/10 • Number of events 4 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
25.0%
3/12 • Number of events 3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
20.0%
1/5 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/10 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
10.0%
1/10 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
16.7%
2/12 • Number of events 2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/5 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/3 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/10 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
10.0%
1/10 • Number of events 1 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/12 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
0.00%
0/5 • Adverse events and death were collected from first dose of study vaccine administration (Day 1) up to end of follow-up per participant, 198 days.
Analysis was performed on the SafAS.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER