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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

April 8, 2019

Primary Completion Date

January 16, 2020

Study Completion Date

July 22, 2021

Conditions
Respiratory Syncytial Virus Infections
Interventions
BIOLOGICAL

RSV (GSK3389245A) lower dose formulation vaccine

1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.

BIOLOGICAL

RSV (GSK3389245A) higher dose formulation vaccine

2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.

BIOLOGICAL

GSK's multicomponent meningococcal B vaccine

3 doses of GSK's multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

BIOLOGICAL

Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine

3 doses of Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

BIOLOGICAL

GSK's pneumococcal polysaccharide conjugate vaccine

3 doses of GSK's pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.

BIOLOGICAL

GSK's meningococcal group A, C, W-135 and Y conjugate vaccine

2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.

DRUG

Placebo

1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 31 and Day 121, depending on the vaccination schedule.

Trial Locations (37)

10330

GSK Investigational Site, Bangkok

15706

GSK Investigational Site, Santiago de Compostela

20520

GSK Investigational Site, Turku

21201

GSK Investigational Site, Baltimore

26040

GSK Investigational Site, Eskişehir

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Majadahonda (Madrid)

30322

GSK Investigational Site, Atlanta

33100

GSK Investigational Site, Tampere

35340

GSK Investigational Site, Izmir

38030

GSK Investigational Site, Kayseri

40243

GSK Investigational Site, Louisville

41014

GSK Investigational Site, Seville

46020

GSK Investigational Site, Valencia

50368

GSK Investigational Site, Wroclaw

83686

GSK Investigational Site, Nampa

760042

GSK Investigational Site, Santiago de Cali

30130-100

GSK Investigational Site, Belo Horizonte

14048-900

GSK Investigational Site, Ribeirão Preto

B3K 6R8

GSK Investigational Site, Halifax

H3T 1C5

GSK Investigational Site, Montreal

G1V 4G2

GSK Investigational Site, Québec

04400

GSK Investigational Site, Järvenpää

00165

GSK Investigational Site, Rome

04530

GSK Investigational Site, México

0401

GSK Investigational Site, Chiriquí

07126

GSK Investigational Site, Panama City

0801

GSK Investigational Site, Panama City

39-200

GSK Investigational Site, Dębica

80-542

GSK Investigational Site, Gdansk

55-100

GSK Investigational Site, Trzebnica

02-739

GSK Investigational Site, Warsaw

09006

GSK Investigational Site, Burgos

M13 9WL

GSK Investigational Site, Manchester

S016 6YD

GSK Investigational Site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03636906 - Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV | Biotech Hunter | Biotech Hunter