Trial Outcomes & Findings for Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (NCT NCT04491877)
NCT ID: NCT04491877
Last Updated: 2025-09-09
Results Overview
An AE is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An unsolicited AE is an observed AE that does not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occur within the first 30 minutes after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
259 participants
Primary outcome timeframe
Cohorts 1 and 3: Within 30 minutes after vaccination on Day 0; Cohorts 2 and 4: Within 30 minutes after vaccination on Days 0 and 56
Results posted on
2025-09-09
Participant Flow
The study was conducted at 26 centers in the United States, Chile and Honduras between 17 September 2020 and 13 April 2023.
A total of 259 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Cohort 1: Respiratory Syncytial Virus (RSV) Low Dose
Participants received a single low dose intranasal spray of RSV ΔNS2/Δ1313/I1314L vaccine (RSVt) on Day 0.
|
Cohort 1: Placebo
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
11
|
10
|
10
|
12
|
61
|
58
|
61
|
|
Overall Study
COMPLETED
|
17
|
16
|
9
|
8
|
10
|
10
|
56
|
51
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
2
|
0
|
2
|
5
|
7
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: Respiratory Syncytial Virus (RSV) Low Dose
Participants received a single low dose intranasal spray of RSV ΔNS2/Δ1313/I1314L vaccine (RSVt) on Day 0.
|
Cohort 1: Placebo
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Deviation
|
1
|
0
|
2
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
0
|
0
|
0
|
2
|
0
|
2
|
2
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
Baseline Characteristics
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Baseline characteristics by cohort
| Measure |
Cohort 1: RSV Low Dose
n=18 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=11 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=58 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
11.2 months
STANDARD_DEVIATION 4.51 • n=5 Participants
|
11.8 months
STANDARD_DEVIATION 3.09 • n=7 Participants
|
11.4 months
STANDARD_DEVIATION 4.01 • n=5 Participants
|
10.8 months
STANDARD_DEVIATION 4.13 • n=4 Participants
|
12.1 months
STANDARD_DEVIATION 3.11 • n=21 Participants
|
12.8 months
STANDARD_DEVIATION 3.95 • n=10 Participants
|
10.4 months
STANDARD_DEVIATION 3.17 • n=115 Participants
|
10.6 months
STANDARD_DEVIATION 3.63 • n=6 Participants
|
10.6 months
STANDARD_DEVIATION 3.78 • n=6 Participants
|
10.9 months
STANDARD_DEVIATION 3.63 • n=64 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
32 Participants
n=6 Participants
|
123 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
33 Participants
n=6 Participants
|
29 Participants
n=6 Participants
|
136 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
30 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
35 Participants
n=6 Participants
|
38 Participants
n=6 Participants
|
187 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Mixed Origin
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
31 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1 and 3: Within 30 minutes after vaccination on Day 0; Cohorts 2 and 4: Within 30 minutes after vaccination on Days 0 and 56Population: The Safety analysis set (SafAS) included participants who received at least 1 administration of the study vaccine.
An AE is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An unsolicited AE is an observed AE that does not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occur within the first 30 minutes after vaccination.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=57 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1 and 3: Within 28 days after vaccination on Day 0; Cohorts 2 and 4: Within 28 days after vaccination on Days 0 and 56Population: The SafAS included participants who received at least 1 administration of the study vaccine. Only participants with available data are reported.
All noxious and unintended responses to a medicinal product related to any dose are considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An administration site reaction is an AR at and around the administration site. Systemic ARs are all ARs that are not injection or administration site reactions.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=11 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=59 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=56 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Administration Site and Systemic Reactions
Solicited administration site reactions
|
15 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
6 Participants
|
53 Participants
|
44 Participants
|
53 Participants
|
|
Number of Participants With Solicited Administration Site and Systemic Reactions
Solicited systemic reactions
|
14 Participants
|
16 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
50 Participants
|
46 Participants
|
51 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1 and 3: Within 28 days after vaccination on Day 0; Cohorts 2 and 4: Within 28 days after vaccination on Days 0 and 56Population: The SafAS included participants who received at least 1 administration of the study vaccine.
An AE is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An unsolicited AE is an observed AE that does not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=57 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
6 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
43 Participants
|
35 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1 and 3: Within 28 days after vaccination on Day 0; Cohorts 2 and 4: Within 28 days after vaccination on Days 0 and 56Population: The SafAS included participants who received at least 1 administration of the study vaccine.
An AESI is one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=57 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
20 Participants
|
11 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1 and 3: Within 28 days after vaccination on Day 0; Cohorts 2 and 4: Within 28 days after vaccination on Days 0 and 56Population: The SafAS included participants who received at least 1 administration of the study vaccine.
An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian/legally authorized representative to seek unplanned medical advice at a physician's office or Emergency Department.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=57 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs)
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
36 Participants
|
29 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 monthsPopulation: The SafAS included participants who received at least 1 administration of the study vaccine.
An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=57 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1 and 3: Day 56; Cohorts 2 and 4: Days 56 and 84Population: The full analysis set (FAS) included all randomized participants who received at least 1 administration of the study vaccine. Only participants analyzed at each specific time point are reported.
RSV A neutralizing antibody measured by microneutralization. RSV-naïve participants are defined as undetectable serum anti-RSV A IgA antibodies.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=11 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=9 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=6 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=8 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=7 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=9 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=29 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=22 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=29 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers Against RSV A Neutralizing Antibody in RSV-Naïve Participants
Day 56
|
75.9 titer
Interval 39.7 to 145.0
|
32.8 titer
Interval 22.0 to 48.7
|
180 titer
Interval 55.4 to 585.0
|
27.5 titer
Interval 21.7 to 35.0
|
99.2 titer
Interval 40.9 to 241.0
|
17.9 titer
Interval 11.4 to 27.9
|
83.7 titer
Interval 49.5 to 142.0
|
79.4 titer
Interval 47.2 to 134.0
|
20.6 titer
Interval 16.4 to 25.9
|
|
Geometric Mean Titers Against RSV A Neutralizing Antibody in RSV-Naïve Participants
Day 84
|
—
|
—
|
181 titer
Interval 65.2 to 500.0
|
19.8 titer
Interval 12.1 to 32.1
|
—
|
—
|
142 titer
Interval 86.4 to 232.0
|
107 titer
Interval 70.0 to 163.0
|
26.3 titer
Interval 18.8 to 37.0
|
SECONDARY outcome
Timeframe: Cohorts 1 and 3: Day 7; Cohorts 2 and 4: Days 7 and 63Population: The SafAS included participants who received at least 1 administration of the study vaccine.
Shedding of the attenuated RSV vaccine strain in nasal swab samples was evaluated by RSV quantitative RT-PCR (qRT-PCR) assay, which specifically detected and quantified RSVt ΔNS2 vaccine strain (RSV ΔNS2/Δ1313/I1314L) in human nasal swab samples.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=7 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=7 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=23 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=20 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Titer of Vaccine Virus Shedding Measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
After first vaccination
|
5.02 log10 copies/mL
Standard Deviation 1.03
|
—
|
6.27 log10 copies/mL
Standard Deviation 0.883
|
—
|
5.82 log10 copies/mL
Standard Deviation 0.666
|
—
|
5.16 log10 copies/mL
Standard Deviation 0.940
|
5.21 log10 copies/mL
Standard Deviation 0.985
|
—
|
|
Titer of Vaccine Virus Shedding Measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
After second vaccination
|
—
|
—
|
5.35 log10 copies/mL
Standard Deviation NA
Standard deviation was not calculable because only one participant was analyzed.
|
—
|
—
|
—
|
5.10 log10 copies/mL
Standard Deviation 1.78
|
5.76 log10 copies/mL
Standard Deviation 1.21
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1 and 3: Day 56; Cohorts 2 and 4: Days 56 and 84Population: The FAS included all randomized participants who received at least 1 administration of the study vaccine. Only participants analyzed at each specific time point are reported.
Infection is defined as detection of vaccine virus in nasal swab by RT-PCR and/or a \>= 4-fold rise in RSV A serum neutralizing antibody titers, or in RSV serum anti-F immunoglobulin G (IgG) antibody titers.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=16 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=8 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=10 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=49 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=48 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=50 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Infected With Vaccine Virus at Days 56 and 84
After second vaccination
|
—
|
—
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
0 percentage of participants
Interval 0.0 to 41.0
|
—
|
—
|
64.1 percentage of participants
Interval 47.2 to 78.8
|
51.2 percentage of participants
Interval 35.1 to 67.1
|
18.8 percentage of participants
Interval 8.9 to 32.6
|
|
Percentage of Participants Infected With Vaccine Virus at Days 56 and 84
After first vaccination
|
82.4 percentage of participants
Interval 56.6 to 96.2
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
100 percentage of participants
Interval 69.2 to 100.0
|
0 percentage of participants
Interval 0.0 to 36.9
|
100 percentage of participants
Interval 69.2 to 100.0
|
0 percentage of participants
Interval 0.0 to 30.8
|
63.3 percentage of participants
Interval 48.3 to 76.6
|
58.3 percentage of participants
Interval 43.2 to 72.4
|
4.0 percentage of participants
Interval 0.5 to 13.7
|
SECONDARY outcome
Timeframe: Cohorts 1 and 3: Day 56; Cohorts 2 and 4: Days 56 and 84Population: The FAS included all randomized participants who received at least 1 administration of the study vaccine. Only participants analyzed at each specific time point are reported.
RSV A neutralizing antibody measured by microneutralization. RSV-experienced participants are defined as detectable serum anti-RSV A IgA antibodies. CI= confidence interval.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=6 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=7 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=1 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=2 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=1 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=14 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=20 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=23 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers Against RSV A Neutralizing Antibody in RSV-Experienced Participants
Day 56
|
134 titer
Interval 37.6 to 476.0
|
52.1 titer
Interval 22.7 to 120.0
|
672 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
—
|
409 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
15.0 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
120 titer
Interval 60.8 to 238.0
|
96.0 titer
Interval 65.0 to 142.0
|
73.5 titer
Interval 44.0 to 123.0
|
|
Geometric Mean Titers Against RSV A Neutralizing Antibody in RSV-Experienced Participants
Day 84
|
—
|
—
|
243 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
—
|
—
|
—
|
120 titer
Interval 65.1 to 221.0
|
102 titer
Interval 70.5 to 148.0
|
96.7 titer
Interval 44.9 to 208.0
|
SECONDARY outcome
Timeframe: Cohorts 1 and 3: Day 56; Cohorts 2 and 4: Days 56 and 84Population: The FAS included all randomized participants who received at least 1 administration of the study vaccine. Only participants analyzed at each specific time point are reported.
The IgG antibodies to RSV F antigen was measured using the anti RSV F IgG ELISA. RSV-naïve and RSV-experienced participants are defined as undetectable or detectable serum anti-RSV A IgA antibodies, respectively.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=11 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=9 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=6 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=8 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=7 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=9 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=27 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=21 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=29 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers Against Serum Anti-F Immunoglobulin G (IgG) Antibody
RSV-experienced participants: Day 56
|
205 titer
Interval 29.5 to 1421.0
|
38.5 titer
Interval 7.6 to 195.0
|
230 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
—
|
337 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
7.50 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
215 titer
Interval 93.8 to 491.0
|
251 titer
Interval 139.0 to 455.0
|
124 titer
Interval 50.7 to 304.0
|
|
Geometric Mean Titers Against Serum Anti-F Immunoglobulin G (IgG) Antibody
RSV-naïve participants: Day 56
|
32.8 titer
Interval 18.1 to 59.6
|
15.0 titer
Interval 6.77 to 33.4
|
58.8 titer
Interval 18.0 to 191.0
|
8.63 titer
Interval 6.2 to 12.0
|
48.7 titer
Interval 26.3 to 90.0
|
7.50 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
43.2 titer
Interval 27.1 to 69.1
|
45.6 titer
Interval 28.1 to 73.9
|
10.4 titer
Interval 7.7 to 14.1
|
|
Geometric Mean Titers Against Serum Anti-F Immunoglobulin G (IgG) Antibody
RSV-naïve participants: Day 84
|
—
|
—
|
135 titer
Interval 55.5 to 331.0
|
8.72 titer
Interval 6.11 to 12.4
|
—
|
—
|
93.1 titer
Interval 49.0 to 177.0
|
61.8 titer
Interval 35.1 to 109.0
|
12.5 titer
Interval 8.3 to 18.7
|
|
Geometric Mean Titers Against Serum Anti-F Immunoglobulin G (IgG) Antibody
RSV-experienced participants: Day 84
|
—
|
—
|
165 titer
95% CI was not calculable when number of participants with available data for the considered endpoint (e.g., number of analyzed participants) were \<= 5 or STD = 0
|
—
|
—
|
—
|
250 titer
Interval 108.0 to 576.0
|
287 titer
Interval 175.0 to 473.0
|
221 titer
Interval 76.8 to 635.0
|
SECONDARY outcome
Timeframe: Cohorts 1 and 3: Within 5 months after vaccination on Day 0; Cohorts 2 and 4: Within 5 months after vaccination on Day 56Population: The FAS included all randomized participants who received at least 1 administration of the study vaccine. Only participants analyzed for this outcome measure are reported.
RSV A neutralizing antibody measured by microneutralization. RSV-naïve and RSV-experienced participants are defined as undetectable or detectable serum anti-RSV A IgA antibodies, respectively.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=17 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=15 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=6 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=7 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=9 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=9 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=37 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=40 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=47 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers Against RSV A Neutralizing Antibody After the RSV Surveillance Season
|
73.2 titer
Interval 45.5 to 118.0
|
24.4 titer
Interval 16.2 to 36.5
|
303 titer
Interval 119.0 to 768.0
|
16.6 titer
Interval 13.0 to 21.3
|
294 titer
Interval 125.0 to 691.0
|
108 titer
Interval 32.4 to 362.0
|
112 titer
Interval 69.3 to 180.0
|
123 titer
Interval 71.7 to 211.0
|
56.6 titer
Interval 33.2 to 96.5
|
SECONDARY outcome
Timeframe: Cohorts 1 and 3: Within 5 months after vaccination on Day 0; Cohorts 2 and 4: Within 5 months after vaccination on Day 56Population: The FAS included all randomized participants who received at least 1 administration of the study vaccine. Only participants analyzed for this outcome measure are reported.
The IgG antibodies to RSV F antigen was measured using the anti RSV F IgG ELISA. RSV-naïve and RSV-experienced participants are defined as undetectable or detectable serum anti-RSV A IgA antibodies, respectively.
Outcome measures
| Measure |
Cohort 1: RSV Low Dose
n=16 Participants
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=15 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=6 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=7 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=8 Participants
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=8 Participants
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=36 Participants
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=39 Participants
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=44 Participants
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers Against Serum Anti-F Immunoglobulin G Antibody After the RSV Surveillance Season
|
63.7 titer
Interval 28.7 to 141.0
|
14.2 titer
Interval 7.51 to 27.0
|
388 titer
Interval 95.2 to 1581.0
|
8.63 titer
Interval 6.12 to 12.2
|
296 titer
Interval 92.6 to 948.0
|
272 titer
Interval 35.8 to 2067.0
|
222 titer
Interval 124.0 to 397.0
|
300 titer
Interval 159.0 to 568.0
|
94.4 titer
Interval 43.6 to 204.0
|
Adverse Events
Cohort 1: RSV Low Dose
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cohort 2: RSV Low Dose
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 3: RSV High Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4: RSV Low Dose
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Cohort 4: RSV High Dose
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Cohort 4: Placebo
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: RSV Low Dose
n=17 participants at risk
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 participants at risk
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 participants at risk
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 participants at risk
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 participants at risk
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 participants at risk
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 participants at risk
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=57 participants at risk
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 participants at risk
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.6%
1/61 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.6%
1/61 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.8%
1/57 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.6%
1/61 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.3%
1/12 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.6%
1/61 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
Other adverse events
| Measure |
Cohort 1: RSV Low Dose
n=17 participants at risk
Participants received a single low dose intranasal spray of RSVt on Day 0.
|
Cohort 1: Placebo
n=18 participants at risk
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 2: RSV Low Dose
n=10 participants at risk
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 2: Placebo
n=10 participants at risk
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
Cohort 3: RSV High Dose
n=10 participants at risk
Participants received a single high dose intranasal spray of RSVt on Day 0.
|
Cohort 3: Placebo
n=12 participants at risk
Participants received a single intranasal spray of placebo on Day 0.
|
Cohort 4: RSV Low Dose
n=61 participants at risk
Participants received low dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: RSV High Dose
n=57 participants at risk
Participants received high dose RSVt intranasal spray once daily on Days 0 and 56.
|
Cohort 4: Placebo
n=61 participants at risk
Participants received placebo intranasal spray once daily on Days 0 and 56.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis Allergic
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
5.6%
1/18 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
4.9%
3/61 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.8%
5/57 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
9.8%
6/61 • Number of events 7 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Gastrointestinal disorders
Teething
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.3%
2/61 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
16.7%
3/18 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
30.0%
3/10 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
40.0%
4/10 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
20.0%
2/10 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.3%
1/12 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
36.1%
22/61 • Number of events 29 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
40.4%
23/57 • Number of events 30 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
45.9%
28/61 • Number of events 30 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
General disorders
Crying
|
52.9%
9/17 • Number of events 9 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
44.4%
8/18 • Number of events 8 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
70.0%
7/10 • Number of events 10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
60.0%
6/10 • Number of events 9 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
70.0%
7/10 • Number of events 7 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
25.0%
3/12 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
50.8%
31/61 • Number of events 43 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
49.1%
28/57 • Number of events 41 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
47.5%
29/61 • Number of events 39 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
27.8%
5/18 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
16.7%
2/12 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
34.4%
21/61 • Number of events 27 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
33.3%
19/57 • Number of events 20 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
36.1%
22/61 • Number of events 23 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
6.6%
4/61 • Number of events 4 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.5%
2/57 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.3%
2/61 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.3%
1/12 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.8%
1/57 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Laryngitis
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
4.9%
3/61 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Myringitis
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
30.0%
3/10 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
31.1%
19/61 • Number of events 26 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
35.1%
20/57 • Number of events 22 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
29.5%
18/61 • Number of events 22 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Otitis Media
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
4.9%
3/61 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.8%
1/57 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.3%
2/61 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Otitis Media Acute
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.6%
1/61 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.5%
2/57 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.3%
2/61 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.3%
2/61 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
5.3%
3/57 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
4.9%
3/61 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Sinusitis Bacterial
|
5.9%
1/17 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.8%
2/17 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.2%
5/61 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
5.3%
3/57 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
6.6%
4/61 • Number of events 4 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
5.6%
1/18 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.6%
1/61 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/57 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/61 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
35.3%
6/17 • Number of events 6 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
33.3%
6/18 • Number of events 6 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
60.0%
6/10 • Number of events 7 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
50.0%
5/10 • Number of events 6 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
70.0%
7/10 • Number of events 7 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
25.0%
3/12 • Number of events 3 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
47.5%
29/61 • Number of events 40 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
66.7%
38/57 • Number of events 50 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
54.1%
33/61 • Number of events 44 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Nervous system disorders
Somnolence
|
29.4%
5/17 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
27.8%
5/18 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
60.0%
6/10 • Number of events 8 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
50.0%
5/10 • Number of events 6 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
50.0%
5/10 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
33.3%
4/12 • Number of events 4 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
37.7%
23/61 • Number of events 31 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
52.6%
30/57 • Number of events 39 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
32.8%
20/61 • Number of events 24 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Psychiatric disorders
Irritability
|
76.5%
13/17 • Number of events 13 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
66.7%
12/18 • Number of events 12 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
80.0%
8/10 • Number of events 10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
80.0%
8/10 • Number of events 10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
70.0%
7/10 • Number of events 7 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
75.0%
9/12 • Number of events 9 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
65.6%
40/61 • Number of events 60 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
64.9%
37/57 • Number of events 53 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
62.3%
38/61 • Number of events 53 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.3%
1/12 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
6.6%
4/61 • Number of events 4 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.8%
5/57 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.2%
5/61 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
58.8%
10/17 • Number of events 10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
33.3%
6/18 • Number of events 6 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
70.0%
7/10 • Number of events 9 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
60.0%
6/10 • Number of events 9 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
70.0%
7/10 • Number of events 7 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
41.7%
5/12 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
75.4%
46/61 • Number of events 68 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
75.4%
43/57 • Number of events 68 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
83.6%
51/61 • Number of events 68 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
82.4%
14/17 • Number of events 14 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
55.6%
10/18 • Number of events 10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
80.0%
8/10 • Number of events 9 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
60.0%
6/10 • Number of events 9 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
80.0%
8/10 • Number of events 8 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
41.7%
5/12 • Number of events 5 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
85.2%
52/61 • Number of events 77 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
75.4%
43/57 • Number of events 70 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
77.0%
47/61 • Number of events 66 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/18 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
10.0%
1/10 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
0.00%
0/10 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
8.3%
1/12 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.6%
1/61 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
1.8%
1/57 • Number of events 1 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
3.3%
2/61 • Number of events 2 • From the first study vaccine administration (Day 0) up to end of the study, maximum of 12 months
Analysis was performed on the safety analysis set.
|
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