A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Study sites: 96 to 97
  2. Eligibility criteria expanded, about 18 words
    • Study sites revised (96)
    • Study description expanded, about 2 words
  3. Study sites: 97 to 96v27
  4. Re-verified, no change to tracked fieldsv26
  5. Site details revised at 1 of 97 sitesv25
Show 23 earlier versionsHide 23 earlier versions
  1. Site details revised at 1 of 97 sitesv24
  2. Study sites: 95 to 97v23
  3. Study sites: 94 to 95v22
  4. Study sites: 93 to 94v21
  5. Site details revised at 2 of 93 sitesv20
  6. Study sites: 89 to 93
    • Eligibility criteria expanded, about 9 words
    v19
  7. Study sites: 90 to 89v18
  8. Site details revised at 2 of 90 sitesv17
  9. Study sites: 89 to 90v16
  10. Study sites: 87 to 89v15
  11. Study sites: 81 to 87v14
  12. Study sites: 78 to 81v13
  13. Study sites: 76 to 78v12
  14. Study sites: 66 to 76v11
  15. Study sites: 56 to 66v10
  16. Study sites: 45 to 56v9
  17. Study sites: 38 to 45v8
  18. Study sites: 39 to 38v7
  19. Study sites: 35 to 39v6
  20. Study sites: 29 to 35v5
  21. Study sites: 23 to 29v4
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 23
    • Primary and study completion dates: Mar 10, 2028 to Feb 24, 2028
    • Start date changed from estimate of Apr 23, 2025 to Apr 16, 2025
    v3
  23. Study sites: 0 to 1
    • Primary and study completion dates: Feb 24, 2028 to Mar 10, 2028
    • Start date: Apr 8, 2025 to Apr 23, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
441 trials monitored
See 31 trials at risk
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.
Trial Details
NCT Number NCT06866405
Lead Sponsor Pfizer
Conditions
(from sponsor)		 RSV Infection
Related terms Respiratory Syncytial Virus Infections
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov