Trial Outcomes & Findings for A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants (NCT NCT02927873)

Last Updated: 2021-10-28

Results Overview

Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

107 participants

Primary outcome timeframe

During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

Results posted on

2021-10-28

Participant Flow

The study was conducted at 32 centers in 8 countries (Canada, Italy, Mexico, Panama, Poland, Spain, Taiwan and United States).

Out of 107 participants enrolled in the study, 21 participants were not assigned to any study group and 4 participants did not receive any study treatment. 82 subjects were vaccinated and included in the Exposed Set.

Participant milestones

Participant milestones
Measure	RSV LD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Overall Study STARTED	11	14	18	11	11	17
Overall Study COMPLETED	9	11	18	11	11	16
Overall Study NOT COMPLETED	2	3	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	RSV LD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Overall Study Lost to Follow-up	0	1	0
Overall Study CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT	0	1	0
Overall Study MIGRATED / MOVED FROM THE STUDY AREA	0	0	1
Overall Study PARENTS NOT ABLE TO COME TO SITE	0	1	0
Overall Study SUBJECT WITHDRAWN AT AN INTERIM TIMEPOINT, BUT ACCEPTED CALLS FOR SAFETY SURVEILLANCE	1	0	0
Overall Study PARENTS REFUSED SAFETY FOLLOW-UP	1	0	0

Baseline Characteristics

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Total n=82 Participants Total of all reporting groups
Age, Continuous	15.4 MONTHS STANDARD_DEVIATION 1.6 • n=5 Participants	15.6 MONTHS STANDARD_DEVIATION 3.3 • n=7 Participants	16.3 MONTHS STANDARD_DEVIATION 4.0 • n=5 Participants	15.0 MONTHS STANDARD_DEVIATION 1.9 • n=4 Participants	16.2 MONTHS STANDARD_DEVIATION 2.7 • n=21 Participants	17.4 MONTHS STANDARD_DEVIATION 3.8 • n=10 Participants	16.1 MONTHS STANDARD_DEVIATION 3.2 • n=115 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	12 Participants n=10 Participants	41 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	5 Participants n=10 Participants	41 Participants n=115 Participants
Race/Ethnicity, Customized AFRICAN HERITAGE / AFRICAN AMERICAN	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized ASIAN - EAST ASIAN HERITAGE	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants
Race/Ethnicity, Customized ASIAN - SOUTH EAST ASIAN HERITAGE	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants n=5 Participants	1 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
Race/Ethnicity, Customized OTHER, NOT SPECIFIED	0 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=10 Participants	34 Participants n=115 Participants
Race/Ethnicity, Customized WHITE - CAUCASIAN / EUROPEAN HERITAGE	11 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=10 Participants	37 Participants n=115 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with the diary card completed after each vaccination.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=13 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Any Solicited Local Adverse Events (AEs) DOSE 1, Any Pain	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) DOSE 1, Any Redness	2 Participants	1 Participants	3 Participants	3 Participants	0 Participants	3 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) DOSE 1, Any Swelling	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) DOSE 2, Any Pain	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) DOSE 2, Any Redness	2 Participants	1 Participants	2 Participants	3 Participants	0 Participants	2 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs) DOSE 2, Any Swelling	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

Assessed solicited general symptoms are drowsiness, fever \[defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C)/99.5 degrees Fahrenheit (°F) for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route, the preferred route for recording temperature in this study being axillary\], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=13 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Any Solicited General AEs DOSE 1, Any Drowsiness	4 Participants	2 Participants	4 Participants	5 Participants	3 Participants	4 Participants
Number of Subjects With Any Solicited General AEs DOSE 1, Any Irritability / Fussiness	3 Participants	3 Participants	4 Participants	4 Participants	2 Participants	2 Participants
Number of Subjects With Any Solicited General AEs DOSE 1, Any Loss Of Appetite	3 Participants	3 Participants	4 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Any Solicited General AEs DOSE 1, Any Fever	3 Participants	3 Participants	10 Participants	3 Participants	2 Participants	0 Participants
Number of Subjects With Any Solicited General AEs DOSE 2, Any Drowsiness	2 Participants	1 Participants	5 Participants	3 Participants	2 Participants	5 Participants
Number of Subjects With Any Solicited General AEs DOSE 2, Any Irritability / Fussiness	3 Participants	1 Participants	5 Participants	3 Participants	1 Participants	6 Participants
Number of Subjects With Any Solicited General AEs DOSE 2, Any Loss Of Appetite	3 Participants	0 Participants	6 Participants	3 Participants	2 Participants	5 Participants
Number of Subjects With Any Solicited General AEs DOSE 2, Any Fever	2 Participants	2 Participants	5 Participants	1 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs are reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Any Unsolicited AEs	9 Participants	9 Participants	13 Participants	7 Participants	10 Participants	13 Participants

PRIMARY outcome

Timeframe: From Day 1 up to Day 61

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of specific interest.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 2

Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2\].

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=15 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Below, Below	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Below, Within	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Within, Below	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Within, Within	11 Participants	11 Participants	13 Participants	11 Participants	6 Participants	13 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Within, Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Above, Within	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 WBC, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 PLC, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 PLC, Within, Below	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 PLC, Within, Within	10 Participants	10 Participants	12 Participants	9 Participants	4 Participants	12 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 PLC, Within, Above	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	3 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 PLC, Above, Within	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 PLC, Above, Above	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 HgL, Below, Below	3 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 HgL, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 HgL, Within, Below	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 HgL, Within, Within	8 Participants	9 Participants	15 Participants	10 Participants	9 Participants	13 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 HgL, Within, Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 HgL, Above, Within	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 HgL, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 8

Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8\].

Outcome measures

Outcome measures
Measure	RSV LD Group n=9 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=3 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=2 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=8 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=5 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=3 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 PLC, Above, Within	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 HgL, Below, Below	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 HgL, Within, Within	7 Participants	2 Participants	2 Participants	7 Participants	5 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 HgL, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 WBC, Within, Within	8 Participants	2 Participants	2 Participants	8 Participants	2 Participants	3 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 WBC, Within, Above	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 WBC, Above, Within	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 PLC, Within, Within	7 Participants	3 Participants	1 Participants	8 Participants	0 Participants	3 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 PLC, Within, Above	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 PLC, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 31

Outcome measures

Outcome measures
Measure	RSV LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=12 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=9 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 HgL, Below, Below	3 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 HgL, Below, Within	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 HgL, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 HgL, Within, Below	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 HgL, Within, Within	7 Participants	9 Participants	15 Participants	9 Participants	8 Participants	14 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 HgL, Within, Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 HgL, Above, Within	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 WBC, Below, Within	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 WBC, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 WBC, Within, Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 WBC, Within, Within	10 Participants	9 Participants	13 Participants	10 Participants	4 Participants	15 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 WBC, Within, Above	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 WBC, Above, Within	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 WBC, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 PLC, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 PLC, Within, Within	9 Participants	8 Participants	15 Participants	8 Participants	4 Participants	13 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 PLC, Within, Above	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 PLC, Above, Within	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 PLC, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 32

Outcome measures

Outcome measures
Measure	RSV LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=15 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Within, Above	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Below, Below	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Below, Within	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Within, Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Within, Below	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Within, Within	6 Participants	7 Participants	14 Participants	9 Participants	8 Participants	14 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Above, Within	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 HgL, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 WBC, Below, Within	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 WBC, Within, Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 WBC, Within, Below	1 Participants	2 Participants	3 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 WBC, Within, Within	9 Participants	7 Participants	11 Participants	10 Participants	5 Participants	14 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 WBC, Within, Above	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 WBC, Above, Within	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 WBC, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 PLC, Within, Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 PLC, Within, Below	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 PLC, Within, Within	10 Participants	7 Participants	15 Participants	7 Participants	4 Participants	14 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 PLC, Within, Above	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 PLC, Above, Within	0 Participants	1 Participants	2 Participants	2 Participants	4 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 PLC, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 38

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point. As per Protocol, hematology testing for RSV HD group on Day 38 was not performed since no platelet decrease (i.e. less than 150000 cells/cubic millimeter) was detected on Day 32.

Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38\].

Outcome measures

Outcome measures
Measure	RSV LD Group n=8 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=1 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=6 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=2 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=2 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 HgL, Below, Below	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 HgL, Within, Within	6 Participants	1 Participants	0 Participants	5 Participants	2 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 HgL, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 WBC, Within, Within	8 Participants	1 Participants	0 Participants	4 Participants	1 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 WBC, Within, Above	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 WBC, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 PLC, Within, Within	7 Participants	1 Participants	0 Participants	5 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 PLC, Within, Above	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 PLC, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 61

Outcome measures

Outcome measures
Measure	RSV LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=12 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=9 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=15 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 HgL, Below, Below	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 HgL, Below, Within	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 HgL, Within, Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 HgL, Within, Below	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 HgL, Within, Within	7 Participants	10 Participants	16 Participants	8 Participants	11 Participants	13 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 HgL, Above, Within	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 HgL, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 WBC, Below, Within	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 WBC, Within, Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 WBC, Within, Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 WBC, Within, Within	9 Participants	11 Participants	14 Participants	8 Participants	6 Participants	10 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 WBC, Within, Above	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 WBC, Above, Within	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 WBC, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 PLC, Within, Unknown	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 PLC, Within, Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 PLC, Within, Within	9 Participants	8 Participants	15 Participants	4 Participants	5 Participants	8 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 PLC, Within, Above	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants	5 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 PLC, Above, Within	0 Participants	1 Participants	2 Participants	2 Participants	4 Participants	1 Participants
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 PLC, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 31

Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31\].

Outcome measures

Outcome measures
Measure	RSV LD Group n=9 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=9 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Above, Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Below, Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Above, Within	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Below, Within	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Below, Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Within, Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Within, Within	7 Participants	10 Participants	15 Participants	11 Participants	7 Participants	13 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 ALT, Within, Above	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 AST, Within, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 AST, Within, Within	9 Participants	7 Participants	13 Participants	9 Participants	7 Participants	14 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 AST, Within, Above	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 AST, Above, Below	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 AST, Above, Within	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 AST, Above, Above	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 CREA, Below, Unknown	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 CREA, Below, Below	4 Participants	3 Participants	1 Participants	7 Participants	1 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 CREA, Below, Within	3 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 CREA, Within, Below	3 Participants	1 Participants	4 Participants	0 Participants	0 Participants	4 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 CREA, Within, Within	0 Participants	7 Participants	10 Participants	3 Participants	7 Participants	12 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 CREA, Within, Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 CREA, Above, Within	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 61

Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 61\].

Outcome measures

Outcome measures
Measure	RSV LD Group n=9 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=16 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 ALT, Below, Below	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 ALT, Below, Within	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 ALT, Within, Within	8 Participants	10 Participants	15 Participants	10 Participants	9 Participants	12 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 ALT, Within, Above	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 ALT, Above, Within	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 ALT, Above, Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 AST, Within, Within	9 Participants	9 Participants	15 Participants	10 Participants	8 Participants	13 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 AST, Within, Above	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 AST, Above, Within	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 AST, Above, Above	0 Participants	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 CREA, Below, Below	4 Participants	2 Participants	2 Participants	7 Participants	1 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 CREA, Below, Within	3 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 CREA, Within, Below	3 Participants	1 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 CREA, Within, Within	0 Participants	8 Participants	10 Participants	3 Participants	8 Participants	15 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 CREA, Within, Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 CREA, Above, Within	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to Day 366

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Any SAEs From Day 1 up to Day 366	1 Participants	1 Participants	1 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From Dose 1 administration (Day 1) up to Day 366

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Dose 1 administration (Day 1) up to Day 366

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection \[RSV infection confirmed on nasal swab positive for RSV A or B by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) performed at sponsor level\]. RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/legally acceptable representatives (LARs) and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Blood Oxygen Saturation (SpO2) lower than (\<) 95 percent (%), OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 RSV-RTI	1 Participants	3 Participants	1 Participants	4 Participants	3 Participants	3 Participants
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 RSV-LRTI	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366 RSV-severe LRTI	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to study conclusion at Day 731

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From Dose 1 administration (Day 1) up to study conclusion at Day 731

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Dose 1 administration (Day 1) up to study conclusion at Day 731

Population: This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.

RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection (RSV infection confirmed on nasal swab positive for RSV A or B by qRT-PCR performed at sponsor level). RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/LARs and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Sp02 \< 95% OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.

Outcome measures

Outcome measures
Measure	RSV LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 RSV-RTI	2 Participants	6 Participants	2 Participants	5 Participants	4 Participants	4 Participants
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 RSV-LRTI	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731 RSV-severe LRTI	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366

Population: This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available CMI results at the specified time point.

Magnitude of cell mediated immunity (CMI) response to the investigational RSV vaccine was measured in terms of frequency of RSV-specific CD4+ T-cells expressing at least two markers upon stimulation with F, N and M2-1 peptide pools and expressed in RSV-specific CD4+ T-cells/million cells. Assessed markers were CD40-L, IL-2, TNF-α and IFN-ɣ.

Outcome measures

Outcome measures
Measure	RSV LD Group n=9 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=3 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=1 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=2 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=1 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV N pool 15/11 Ag, Day 61	70 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 165.0	144 RSV-specific CD4+ T-cells/million cells Interval 34.0 to 426.0	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 1.0	71 RSV-specific CD4+ T-cells/million cells Interval 50.0 to 117.0	64.5 RSV-specific CD4+ T-cells/million cells Interval 52.0 to 77.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV M2-1 pool 15/11 Ag, Screening	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 9.0	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 10.0	56 RSV-specific CD4+ T-cells/million cells Interval 56.0 to 56.0	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 1.0	214 RSV-specific CD4+ T-cells/million cells Interval 214.0 to 214.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV N pool 15/11 Ag, Day 366	56 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 269.0	41.5 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 82.0	82 RSV-specific CD4+ T-cells/million cells Interval 82.0 to 82.0	89 RSV-specific CD4+ T-cells/million cells Interval 42.0 to 113.0	78 RSV-specific CD4+ T-cells/million cells Interval 27.0 to 129.0	91 RSV-specific CD4+ T-cells/million cells Interval 91.0 to 91.0
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV M2-1 pool 15/11 Ag, Day 31	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 34.0	21.5 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 42.0	229 RSV-specific CD4+ T-cells/million cells Interval 229.0 to 229.0	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 13.0	145.5 RSV-specific CD4+ T-cells/million cells Interval 100.0 to 191.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV M2-1 pool 15/11 Ag, Day 61	8 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 57.0	2 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 55.0	46 RSV-specific CD4+ T-cells/million cells Interval 46.0 to 46.0	30 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 33.0	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 1.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV M2-1 pool 15/11 Ag, Day 366	7 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 81.0	2.5 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 4.0	13 RSV-specific CD4+ T-cells/million cells Interval 13.0 to 13.0	23 RSV-specific CD4+ T-cells/million cells Interval 6.0 to 27.0	48 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 95.0	56 RSV-specific CD4+ T-cells/million cells Interval 56.0 to 56.0
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV N pool 15/11 Ag, Day 31	129.5 RSV-specific CD4+ T-cells/million cells Interval 23.5 to 226.5	229 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 457.0	289 RSV-specific CD4+ T-cells/million cells Interval 289.0 to 289.0	58 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 102.0	193 RSV-specific CD4+ T-cells/million cells Interval 180.0 to 206.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV F pool 15/11 Ag, Screening	169.5 RSV-specific CD4+ T-cells/million cells Interval 85.0 to 218.0	123 RSV-specific CD4+ T-cells/million cells Interval 32.0 to 268.0	1 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 1.0	176 RSV-specific CD4+ T-cells/million cells Interval 120.0 to 336.0	1813 RSV-specific CD4+ T-cells/million cells Interval 1813.0 to 1813.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV F pool 15/11 Ag, Day 31	291 RSV-specific CD4+ T-cells/million cells Interval 231.0 to 469.0	546 RSV-specific CD4+ T-cells/million cells Interval 484.0 to 608.0	1086 RSV-specific CD4+ T-cells/million cells Interval 1086.0 to 1086.0	234 RSV-specific CD4+ T-cells/million cells Interval 48.0 to 350.0	1129.5 RSV-specific CD4+ T-cells/million cells Interval 379.0 to 1880.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV F pool 15/11 Ag, Day 61	214 RSV-specific CD4+ T-cells/million cells Interval 74.5 to 331.5	451 RSV-specific CD4+ T-cells/million cells Interval 93.0 to 495.0	394 RSV-specific CD4+ T-cells/million cells Interval 394.0 to 394.0	105.5 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 193.0	759 RSV-specific CD4+ T-cells/million cells Interval 218.0 to 1300.0	—
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV F pool 15/11 Ag, Day 366	206 RSV-specific CD4+ T-cells/million cells Interval 71.0 to 288.5	108.5 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 216.0	1164 RSV-specific CD4+ T-cells/million cells Interval 1164.0 to 1164.0	252.5 RSV-specific CD4+ T-cells/million cells Interval 169.5 to 495.0	664.5 RSV-specific CD4+ T-cells/million cells Interval 252.0 to 1077.0	229 RSV-specific CD4+ T-cells/million cells Interval 229.0 to 229.0
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools RSV N pool 15/11 Ag, Screening	51 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 121.0	54 RSV-specific CD4+ T-cells/million cells Interval 1.0 to 369.0	140 RSV-specific CD4+ T-cells/million cells Interval 140.0 to 140.0	104 RSV-specific CD4+ T-cells/million cells Interval 27.0 to 174.0	253 RSV-specific CD4+ T-cells/million cells Interval 253.0 to 253.0	—

SECONDARY outcome

Timeframe: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366

Population: This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available immunogenicity results for the specified assay and time point.

Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers.

Outcome measures

Outcome measures
Measure	RSV LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=13 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Anti-RSV-A Neutralizing Antibody Titers Screening	127.4 Titers Interval 44.0 to 368.5	179.4 Titers Interval 99.2 to 324.5	495.7 Titers Interval 242.5 to 1013.1	376.5 Titers Interval 89.3 to 1587.5	214.6 Titers Interval 80.8 to 569.9	332 Titers Interval 158.5 to 695.4
Anti-RSV-A Neutralizing Antibody Titers Day 31	711.7 Titers Interval 229.7 to 2204.9	1646 Titers Interval 815.8 to 3321.0	2203.9 Titers Interval 1383.7 to 3510.3	645.9 Titers Interval 266.3 to 1566.5	703.9 Titers Interval 244.3 to 2028.4	295 Titers Interval 149.6 to 581.8
Anti-RSV-A Neutralizing Antibody Titers Day 61	1081.3 Titers Interval 648.3 to 1803.3	1809 Titers Interval 1022.6 to 3200.2	1974.9 Titers Interval 1356.9 to 2874.3	421.5 Titers Interval 178.9 to 993.1	316.4 Titers Interval 169.0 to 592.3	307.1 Titers Interval 148.5 to 634.9
Anti-RSV-A Neutralizing Antibody Titers Day 366	236.9 Titers Interval 105.7 to 531.0	837 Titers Interval 546.6 to 1281.6	1038 Titers Interval 629.3 to 1712.3	398.5 Titers Interval 163.5 to 971.7	545.4 Titers Interval 269.4 to 1104.3	493.8 Titers Interval 216.0 to 1129.1

SECONDARY outcome

Timeframe: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366

Humoral response to the investigational RSV vaccine was measured as anti-RSV F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	RSV LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=13 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Anti-RSV-F Antibody Concentrations Day 61	6167.5 EU/mL Interval 3701.3 to 10277.1	15577.4 EU/mL Interval 8012.9 to 30283.2	15083.8 EU/mL Interval 10555.0 to 21555.7	2983.3 EU/mL Interval 1612.8 to 5518.3	3182 EU/mL Interval 1737.1 to 5828.8	2101.3 EU/mL Interval 1038.3 to 4252.6
Anti-RSV-F Antibody Concentrations Day 366	3988.5 EU/mL Interval 1789.4 to 8890.1	6521.1 EU/mL Interval 3702.5 to 11485.4	6490.7 EU/mL Interval 4509.7 to 9341.8	3591.3 EU/mL Interval 1472.8 to 8756.9	3047.5 EU/mL Interval 1577.7 to 5886.6	4487.9 EU/mL Interval 1936.8 to 10398.8
Anti-RSV-F Antibody Concentrations Screening	2082 EU/mL Interval 864.3 to 5015.5	2061.6 EU/mL Interval 1343.6 to 3163.4	3686.4 EU/mL Interval 1964.5 to 6917.5	3933.2 EU/mL Interval 1789.1 to 8646.7	1216.3 EU/mL Interval 472.9 to 3128.7	2988.6 EU/mL Interval 1420.9 to 6286.0
Anti-RSV-F Antibody Concentrations Day 31	4807.2 EU/mL Interval 1738.5 to 13292.8	10810.9 EU/mL Interval 4062.2 to 28771.1	17419 EU/mL Interval 11639.6 to 26068.2	6134.2 EU/mL Interval 2752.0 to 13673.0	7911.6 EU/mL Interval 3187.7 to 19636.0	2350.6 EU/mL Interval 1235.9 to 4470.7

SECONDARY outcome

Timeframe: At Pre-vaccination (Screening), Day 31 and Day 61

Humoral response to the investigational RSV vaccine was measured as Palivizumab-competing antibody concentrations and expressed as geometric mean concentrations (GMCs) in microgram/milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	RSV LD Group n=10 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=13 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 Participants RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Palivizumab-competing Antibody Concentrations Day 61	6.3 µg/mL Interval 4.6 to 8.6	15.2 µg/mL Interval 9.2 to 25.1	14 µg/mL Interval 10.1 to 19.4	6.1 µg/mL Interval 4.3 to 8.6	7 µg/mL Interval 4.5 to 10.8	6.6 µg/mL Interval 4.8 to 9.0
Palivizumab-competing Antibody Concentrations Screening	5.2 µg/mL Interval 4.3 to 6.3	4.8 µg/mL Interval 4.8 to 4.8	6.6 µg/mL Interval 5.0 to 8.6	6.2 µg/mL Interval 4.2 to 9.2	4.8 µg/mL Interval 4.8 to 4.8	7.2 µg/mL Interval 4.8 to 10.9
Palivizumab-competing Antibody Concentrations Day 31	7.9 µg/mL Interval 5.3 to 11.7	11.1 µg/mL Interval 6.2 to 19.8	17.5 µg/mL Interval 13.0 to 23.6	8 µg/mL Interval 4.4 to 14.5	12.5 µg/mL Interval 6.2 to 25.5	6.8 µg/mL Interval 4.8 to 9.6

Adverse Events

RSV LD Group

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

RSV MD Group

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

RSV HD Group

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo LD Group

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo MD Group

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo HD Group

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RSV LD Group n=11 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	18.2% 2/11 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Coronavirus infection	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Gastroenteritis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.1% 2/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Bronchitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Enterovirus infection	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Escherichia urinary tract infection	9.1% 1/11 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Rhinovirus infection	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Tonsillitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Herpangina	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Pneumonia	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Nervous system disorders Unresponsive to stimuli	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Nervous system disorders Febrile convulsion	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
General disorders Pyrexia	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.

Other adverse events

Other adverse events
Measure	RSV LD Group n=11 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV MD Group n=14 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	RSV HD Group n=18 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.	Placebo LD Group n=11 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo MD Group n=11 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.	Placebo HD Group n=17 participants at risk RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Immune system disorders Seasonal allergy	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Blood and lymphatic system disorders Anaemia	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
General disorders Pyrexia	45.5% 5/11 • Number of events 7 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	35.7% 5/14 • Number of events 5 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	61.1% 11/18 • Number of events 15 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	45.5% 5/11 • Number of events 5 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	36.4% 4/11 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.8% 2/17 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
General disorders Injection site erythema	18.2% 2/11 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	14.3% 2/14 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	22.2% 4/18 • Number of events 5 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	27.3% 3/11 • Number of events 6 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	23.5% 4/17 • Number of events 5 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
General disorders Injection site pain	27.3% 3/11 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	21.4% 3/14 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.1% 2/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	18.2% 2/11 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	23.5% 4/17 • Number of events 5 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
General disorders Injection site swelling	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	17.6% 3/17 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Nasopharyngitis	18.2% 2/11 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	42.9% 6/14 • Number of events 10 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	38.9% 7/18 • Number of events 8 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	36.4% 4/11 • Number of events 5 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	29.4% 5/17 • Number of events 7 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Gastroenteritis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	16.7% 3/18 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	27.3% 3/11 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Conjunctivitis	27.3% 3/11 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Pharyngotonsillitis	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Influenza	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.1% 2/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Tonsillitis streptococcal	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Otitis media	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Varicella	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Impetigo	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.1% 2/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Bronchiolitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Croup infectious	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Gastroenteritis viral	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Paronychia	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Pharyngitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Tonsillitis	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Acarodermatitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Bronchitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Infections and infestations Pharyngitis streptococcal	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Gastrointestinal disorders Diarrhoea	18.2% 2/11 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	14.3% 2/14 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	18.2% 2/11 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	18.2% 2/11 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	17.6% 3/17 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Gastrointestinal disorders Teething	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.1% 2/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Gastrointestinal disorders Constipation	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Gastrointestinal disorders Stomatitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.1% 2/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	18.2% 2/11 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.6% 1/18 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Metabolism and nutrition disorders Decreased appetite	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	11.1% 2/18 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	17.6% 3/17 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Injury, poisoning and procedural complications Face injury	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Injury, poisoning and procedural complications Head injury	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/14 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.
Psychiatric disorders Irritability	9.1% 1/11 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	7.1% 1/14 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/18 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	0.00% 0/11 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.	5.9% 1/17 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER