Respiratory Syncytial Virus Infections Clinical Trial
Official title:
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
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.
The RSV PED-002 study, designed to evaluate the safety, reactogenicity and immunogenicity of the RSV candidate vaccine when administered in 3 sequential doses to seropositive infants aged 12 to 23 months, will be conducted in an observer-blind manner in Epoch 1 and single-blinded in Epoch 2. ;
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