Last updated on August 2019

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


Brief description of study

The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV, and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.

Detailed Study 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 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).

Clinical Study Identifier: NCT03636906

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