Trial Outcomes & Findings for Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV (NCT NCT03636906)

Last Updated: 2022-07-27

Results Overview

Assessed solicited local AEs are erythema, pain and swelling at injection site. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter greater than 0 millimeters. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, active comparators pooled and placebo groups separately to compare the expected adverse events observed from routine pediatric vaccines (active comparators) with the investigational RSV vaccine. Placebo was not pooled with active comparators as no significant difference was expected in AEs when placebo was pooled with active comparators. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

201 participants

Primary outcome timeframe

During a 7-day follow-up period after the first vaccination (administered at Day 1)

Results posted on

2022-07-27

Participant Flow

Analysis of this study results were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating counties rather than randomization to each of the groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Participant milestones

Participant milestones
Measure	RSV1D Pooled Group Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Comparator_Placebo Pooled Group Subjects received either one of interventions schedules as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . * 2 doses of Placebo alone (administered at Days 1 and 31).
Overall Study STARTED	65	71	65
Overall Study COMPLETED	61	71	60
Overall Study NOT COMPLETED	4	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	RSV1D Pooled Group Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	Comparator_Placebo Pooled Group Subjects received either one of interventions schedules as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . * 2 doses of Placebo alone (administered at Days 1 and 31).
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	0
Overall Study CONSENT WITHDRAWAL, NOT DUE TO AN ADVERSE EVENT AND/OR A SERIOUS ADVERSE EVENT	2	1
Overall Study NOT WILLING TO PARTICIPATE THIS VISIT	1	2
Overall Study Other	0	1

Baseline Characteristics

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Comparator_Placebo Pooled Group n=65 Participants Subjects received either one of interventions schedules as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . * 2 doses of Placebo alone (administered at Days 1 and 31).	Total n=201 Participants Total of all reporting groups
Age, Continuous	6.4 MONTHS STANDARD_DEVIATION 0.5 • n=93 Participants	6.5 MONTHS STANDARD_DEVIATION 0.5 • n=4 Participants	6.5 MONTHS STANDARD_DEVIATION 0.5 • n=27 Participants	6.5 MONTHS STANDARD_DEVIATION 0.5 • n=483 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	33 Participants n=4 Participants	31 Participants n=27 Participants	96 Participants n=483 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	38 Participants n=4 Participants	34 Participants n=27 Participants	105 Participants n=483 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants
Race/Ethnicity, Customized ASIAN	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized OTHER, Not specified	25 Participants n=93 Participants	29 Participants n=4 Participants	25 Participants n=27 Participants	79 Participants n=483 Participants
Race/Ethnicity, Customized WHITE	38 Participants n=93 Participants	39 Participants n=4 Participants	37 Participants n=27 Participants	114 Participants n=483 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period after the first vaccination (administered at Day 1)

Population: Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after first vaccination.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=22 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group n=42 Participants Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) Any Erythema	5 Participants	6 Participants	0 Participants	22 Participants	—	—	—
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) Any Pain	11 Participants	10 Participants	1 Participants	17 Participants	—	—	—
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) Any Swelling	2 Participants	3 Participants	2 Participants	11 Participants	—	—	—

PRIMARY outcome

Timeframe: During a 7-day follow-up period after the second vaccination (administered at Day 31)

Population: Analysis was performed on Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after second vaccination.

Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, active comparators pooled and placebo groups separately to compare the expected adverse events observed from routine pediatric vaccines (active comparators) with the investigational RSV vaccine. Placebo was not pooled with active comparators as no significant difference was expected in AEs when placebo was pooled with active comparators. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=63 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=20 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group n=41 Participants Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) Any Erythema	8 Participants	7 Participants	0 Participants	11 Participants	—	—	—
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) Any Pain	5 Participants	9 Participants	0 Participants	6 Participants	—	—	—
Number of Subjects With Any Solicited Local Adverse Events (AEs) During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) Any Swelling	1 Participants	3 Participants	0 Participants	6 Participants	—	—	—

PRIMARY outcome

Timeframe: During a 7-day follow-up period after the first vaccination (administered at Day 1)

Population: Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after first vaccination.

Assessed solicited general adverse events are drowsiness, fever \[defined as temperature equal to or above (\>=) 38.degrees Celsius (C)/100.4 Fahrenheit (F) by any route\], irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, each of the active comparators and placebo groups separately as the study interest was to investigate solicited AEs during the follow-up period of RSV vaccine administration, compared to placebo and routine pediatric vaccines, especially comparing to the rates of Bexsero-related fever. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=22 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group n=28 Participants Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group n=1 Participants Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group n=1 Participants Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group n=12 Participants Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) Any Loss of appetite	12 Participants	17 Participants	8 Participants	12 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) Any Drowsiness	12 Participants	19 Participants	7 Participants	11 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) Any Fever	9 Participants	24 Participants	5 Participants	11 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the First Vaccination (Administered at Day 1) Any Irritability/Fussiness	25 Participants	31 Participants	9 Participants	20 Participants	0 Participants	1 Participants	4 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period after the second vaccination (administered at Day 31)

Population: Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after second vaccination.

Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, each of the active comparators and placebo groups separately as the study interest was to investigate solicited AEs during the follow-up period of RSV vaccine administration, compared to placebo and routine pediatric vaccines, especially comparing to the rates of Bexsero-related fever. As pre-specified in the protocol, the choice of active comparator or placebo was based on each participating country's standard of care.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=63 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=20 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group n=27 Participants Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group n=1 Participants Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group n=1 Participants Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group n=12 Participants Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) Any Loss of appetite	7 Participants	22 Participants	3 Participants	4 Participants	0 Participants	0 Participants	4 Participants
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) Any Drowsiness	10 Participants	18 Participants	3 Participants	5 Participants	0 Participants	0 Participants	4 Participants
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) Any Fever	6 Participants	28 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects With Any Solicited General AEs During a 7-day Follow-up Period After the Second Vaccination (Administered at Day 31) Any Irritability/Fussiness	18 Participants	33 Participants	3 Participants	9 Participants	0 Participants	0 Participants	6 Participants

PRIMARY outcome

Timeframe: During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31

Population: The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. Study interest was to check unsolicited AEs only during the follow-up period of study RSV vaccine.

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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Any Unsolicited AEs	34 Participants	45 Participants	36 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 up to Day 61

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

Assessed serious adverse events (SAEs) include 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. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of theindividual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61	3 Participants	3 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31

Population: The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. Study interest was to check episode of spontaneous or excessive bleeding (AE of special interest) only during the follow-up period of study RSV vaccine.

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 special interest. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Special Interest)	1 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)

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

According to standardized case definitions,RSV-RTI is a subject having runny nose/blocked nose/ cough \& confirmed RSV infection.RSV-LRTI is a subject having history of cough/ difficulty breathing\[based on history reported by parents\] \& blood oxygen saturation (SpO2) lower than(\<)95 percent (%)/ respiratory rate (RR) increase \& confirmed RSV infection Severe RSV-LRTI-Cases meeting RSV-LRTI case definition \& an SpO2\<93 %/lower chest wall in-drawing. Very severe RSV-LRTI-Cases meeting RSV-LRTI case definition \& an SpO2\<90%/inability to feed/failure to respond/unconscious.Analysis of this outcome measure was reported for RSV1D pooled, RSV2D pooled \& comparator\_placebo pooled groups as data was collected based on different standard of care provided at participating countries rather than randomization to each of the groups.Per the pre-specified analysis plan,data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI), Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) RSV-RTI	21 Participants	17 Participants	27 Participants	—	—	—	—
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI), Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) RSV-LRTI	3 Participants	3 Participants	4 Participants	—	—	—	—
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI), Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) Severe RSV-LRTI	1 Participants	1 Participants	3 Participants	—	—	—	—
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI), Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) Very severe RSV-LRTI	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)

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

Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) RSV-RTI	23 Participants	18 Participants	30 Participants	—	—	—	—
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) RSV-LRTI	3 Participants	3 Participants	4 Participants	—	—	—	—
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) Severe RSV-LRTI	1 Participants	1 Participants	3 Participants	—	—	—	—
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI and Very Severe RSV-LRTI (According to Standardized Case Definitions) Very severe RSV-LRTI	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)

Population: The analysis was performed on the Exposed set, which includes all subjects with at least one study vaccine administration documented.

Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the 15 groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With SAEs From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years)	7 Participants	11 Participants	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)

Population: The analysis was performed on the Exposed set, which includes all subjects with at least one study vaccine administration documented.

Subjects experiencing an LRTI associated with RSV infection were reported as AE of special 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. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the First RSV Transmission Season (up to 1 Year)	7 Participants	6 Participants	7 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)

Population: The analysis was performed on the Exposed set, which includes all subjects with at least one study vaccine administration documented.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=65 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=65 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of Subjects With RSV-LRTI (AE of Special Interest) From First Vaccination (Day 1) up to the End of the Second RSV Transmission Season (up to 2 Years)	7 Participants	6 Participants	7 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)

Population: The analysis was performed on the Exposed set with a negative RSV exposure status, which included all vaccinated subjects assessed as RSV unexposed at screening based on in-stream baseline serological testing.

Very severe RSV LRTI are cases meeting the case definition of RSV-LRTI AND a SpO2 \<90%, OR inability to feed, OR failure to respond/unconscious. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=49 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=58 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=52 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Number of RSV Infected Subjects With a Negative RSV Exposure Status (at Screening Based on In-stream Baseline Serological Testing) With Very Severe RSV-LRTI (According to Standardized Case Definition)	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year)

Population: The analysis was performed on the Per-protocol set for analysis of immunogenicity, which included all subjects with at least one study vaccine administration documented, who complied with eligibility criteria, study procedures up to the end of the study and had 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. Analysis of this outcome measure were reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=64 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=61 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Anti-RSV-A Neutralizing Antibody Titers Screening	26.8 Titers Interval 20.7 to 34.6	29.6 Titers Interval 23.6 to 37.3	32.2 Titers Interval 24.9 to 41.6	—	—	—	—
Anti-RSV-A Neutralizing Antibody Titers Day 31	60.2 Titers Interval 44.2 to 81.9	116.2 Titers Interval 87.6 to 153.9	18.9 Titers Interval 14.8 to 24.1	—	—	—	—
Anti-RSV-A Neutralizing Antibody Titers Day 61	54.3 Titers Interval 37.7 to 78.0	259.4 Titers Interval 211.6 to 318.1	14.4 Titers Interval 11.8 to 17.7	—	—	—	—
Anti-RSV-A Neutralizing Antibody Titers EOS1	165 Titers Interval 95.0 to 286.6	223.7 Titers Interval 154.7 to 323.4	66.3 Titers Interval 40.2 to 109.5	—	—	—	—

SECONDARY outcome

Timeframe: At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year)

Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL). Analysis of this outcome measure was reported for the RSV1D pooled, RSV2D pooled, and comparator\_placebo pooled groups as data collection was based on different standard of care provided at participating countries rather than randomization to each of the individual groups. According to the pre-specified analysis plan, data collected for participant flow, baseline characteristics and adverse events reporting were not analyzed for the individual groups.

Outcome measures

Outcome measures
Measure	RSV1D Pooled Group n=64 Participants Subjects received the interventions as follows: * Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.	RSV2D Pooled Group n=71 Participants Subjects received the interventions as follows: * Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). * Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.	Placebo Group n=61 Participants Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).	Active Comparators Pooled Group Subjects received either one of interventions schedule as follows: * 3 doses of GSK's multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). * 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). * 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .	Nimenrix Group Subjects received 3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).	Synflorix Group Subjects received 3 doses of GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).	Menveo Group Subjects received 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)
Anti-RSV-F Antibody Concentrations Screening	93.1 EU/mL Interval 72.7 to 119.1	81.9 EU/mL Interval 61.8 to 108.6	86 EU/mL Interval 65.5 to 112.7	—	—	—	—
Anti-RSV-F Antibody Concentrations Day 31	2035.2 EU/mL Interval 1490.0 to 2779.9	4550.8 EU/mL Interval 3354.6 to 6173.7	46.2 EU/mL Interval 31.6 to 67.6	—	—	—	—
Anti-RSV-F Antibody Concentrations Day 61	1976.5 EU/mL Interval 1346.2 to 2901.8	9287.9 EU/mL Interval 7885.5 to 10939.7	24.6 EU/mL Interval 18.3 to 33.0	—	—	—	—
Anti-RSV-F Antibody Concentrations EOS1	5108.7 EU/mL Interval 3096.7 to 8428.0	4935.5 EU/mL Interval 3639.8 to 6692.4	345.1 EU/mL Interval 165.9 to 717.7	—	—	—	—

Adverse Events

RSV1D Pooled Group

Serious events: 7 serious events

Other events: 57 other events

Deaths: 0 deaths

RSV2D Pooled Group

Serious events: 11 serious events

Other events: 67 other events

Deaths: 0 deaths

Comparator_Placebo Pooled Group

Serious events: 3 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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