Study Phase 1

A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health

Trial Information

Generic NameAd26.RSV.preFProduct NameN/ATherapeutic AreaAnti-Infectives for Systemic UseProduct ClassVaccinesCondition StudiedRespiratory Syncytial VirusesChemical SubgroupsN/APharmacological SubgroupsN/A
Sponsor Protocol NumberVAC18193RSV1003Enrollment73Data PartnerJohnson & Johnson% Female50%Mean/Median Age (Years)68% White93%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Disclaimer

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