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RSVpreF

Phase 3 Clinical Trial

Developer: Pfizer  |  Target Disease: RSV

Category Resource

Explore licensed vaccines, adverse event reporting data, and history for this disease.

View RSV Vaccine Guide →
Development Phase Phase 3 Clinical Trial Primary Status
Platform Technology Biological (unspecified platform) Biologic Architecture
Target Indication RSV Pathogen / Antigen
Last Verified 2026-07-10 Tier 1 Multi-Source Checked

Multi-Jurisdiction Regulatory Status

Official licensing, rolling submissions, or authorization status tracked across major health authorities.

Regulatory Authority Status & Details
US FDA Not Filed / Pre-submission
EMA (Europe) Not Filed / Pre-submission
Health Canada Not Filed / Pre-submission
TGA (Australia) Not Filed / Pre-submission

Scientific Profile & Documentation

Platform Architecture
Biological (unspecified platform)
Lead Developer
Pfizer
Next Expected Milestone
Primary completion (most advanced trial): 2027-01-18 (registry estimate)
Analyst & Development Notes
Auto-grouped from 4 ClinicalTrials.gov record(s) sharing intervention/sponsor. Phases and timelines are registry fields and may lag company disclosures.
Primary Source Documentation
ClinicalTrials.gov NCT05035212 →
Additional Sources & Literature

Registered Clinical Trials & Studies

Direct registry links to active, completed, or pivotal registration studies across phases.

NCT05035212 Phase 3 Clinical Trial

Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.

Status: Active / Ongoing • Expected Readout: 2027-01-18
NCT07543380 Phase 3 Clinical Trial

A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.

Status: Active / Ongoing • Expected Readout: 2026-08-31
NCT06866405 Phase 3 Clinical Trial

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

Status: Active / Ongoing • Expected Readout: 2028-02-24
NCT07653100 Phase 3 Clinical Trial

A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF

Status: Active / Ongoing • Expected Readout: 2027-01-25

Milestone Overview

  • Stage Verification
    Phase 3 Clinical Trial confirmed as of 2026-07-10.
  • Target Milestone
    Primary completion (most advanced trial): 2027-01-18 (registry estimate)

Vaccine Data Navigator Candidate Profile Registry:

This candidate profile is indexed across all clinical development levels (Preclinical through Phase 1–3, Regulatory Filing, and Licensure) from primary registry databases (ClinicalTrials.gov, WHO ICTRP, FDA CBER, EMA, Health Canada, TGA Australia). Data are updated continuously to track global biologic and vaccine pipelines.