NCT02927873 - 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 | Biotech Hunter

Enrollment

107

Participants

Timeline

Start Date

January 11, 2017

Primary Completion Date

February 19, 2019

Study Completion Date

November 26, 2020

Conditions

Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV (GSK3389245A) low dose formulation vaccine

2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

BIOLOGICAL

RSV (GSK3389245A) middle dose formulation vaccine

2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

BIOLOGICAL

RSV (GSK3389245A) high dose formulation vaccine

2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

DRUG

Placebo

2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

Trial Locations (24)

100

GSK Investigational Site, Taipei

104

GSK Investigational Site, Taipei

300

GSK Investigational Site, Hsinchu

333

GSK Investigational Site, Taoyuan District

13210

GSK Investigational Site, Syracuse

15706

GSK Investigational Site, Santiago de Compostela

20122

GSK Investigational Site, Milan

21702

GSK Investigational Site, Frederick

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Majadahonda (Madrid)

46020

GSK Investigational Site, Valencia

57105

GSK Investigational Site, Sioux Falls

66604

GSK Investigational Site, Topeka

80045

GSK Investigational Site, Aurora

92804

GSK Investigational Site, Anaheim

B3K 6R8

GSK Investigational Site, Halifax

06132

GSK Investigational Site, Perugia

04530

GSK Investigational Site, México

0401

GSK Investigational Site, David

0801

GSK Investigational Site, Panama City

39-200

GSK Investigational Site, Dębica

09006

GSK Investigational Site, Burgos