At a glance
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A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months
In Brief
A Phase 2 clinical trial evaluating RSV (GSK3389245A) low dose formulation vaccine, RSV (GSK3389245A) middle dose formulation vaccine, and 2 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 107 participants across 24 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.
Study Details
Timeline
Interventions
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.
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.
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.
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.