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 AreaInfectious Disease & VaccinesEnrollment5815% Female57.6%% White92.5%
Product ClassImmunizationsSponsor Protocol NumberVAC18193RSV2001 (CYPRESS)Data PartnerJohnson & JohnsonCondition StudiedRespiratory Syncytial VirusesMean/Median Age (Years)71.7

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

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.