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

Summary

Participation Requirements

Description

The RSV PED-011 study is indicated as a Phase 1 in the study design due to programming limitations. In fact, the study is considered a Phase 1/2 and is designed to evaluate the safety, reactogenicity and immunogenicity of the RSV candidate vaccine when administered to infants aged 6 and 7 months bef...

The RSV PED-011 study is indicated as a Phase 1 in the study design due to programming limitations. In fact, the study is considered a Phase 1/2 and is designed to evaluate the safety, reactogenicity and immunogenicity of the RSV candidate vaccine when administered to infants aged 6 and 7 months before moving to a proof-of-concept trial in infants. The ChAd155-RSV vaccine will be administered before the RSV season to increase the probability of enrolling infants unexposed to RSV, who will be followed through two RSV seasons. For the 2 dose groups, the second dose of ChAd155-RSV vaccine will be given one month after the first dose. Approximately two thirds of the infants (100) in this study will be given the ChAd155-RSV vaccine, whereas all infants (150) will receive either an active control comparator vaccine (Bexsero, or Nimenrix, or Synflorix, or Menveo), or Placebo (Formulation buffer S9b). After a screening visit lasting up to 30 days (Epoch 1), this study will be conducted in an observer-blind manner, during the 2 month vaccination phase (Epoch 2) and in a single-blinded manner during the follow-up phase, for 10 months until the end of the first RSV season (Epoch 3) and then for an additional follow-up year, until the end of the second RSV season (Epoch 4).

Tracking Information