Study Phase 2

A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of RT PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older

Trial Information

Generic NameAd26.RSV.preFProduct NameN/ATherapeutic AreaAnti-Infectives for Systemic UseProduct ClassVaccinesCondition StudiedRespiratory Syncytial VirusesChemical SubgroupsN/APharmacological SubgroupsN/A
Sponsor Protocol NumberVAC18193RSV2001Enrollment5815Data PartnerJohnson & Johnson% Female57.6%Mean/Median Age (Years)71.7% White92.5%

Supporting Documentation

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

Additional primary citation found here: https://pubmed.ncbi.nlm.nih.gov/38801826/

Disclaimer

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