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PG4 Multivalent Vaccine

Phase 3 Clinical Trial

Developer: Pfizer  |  Target Disease: Pneumococcal disease

Category Resource

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

View Pneumococcal disease Vaccine Guide →
  1. Phase 1
  2. Phase 2
  3. Phase 3
  4. Filed
  5. Approved
Development Phase Phase 3 Clinical Trial Primary Status
Platform Technology Conjugate vaccine Biologic Architecture
Target Indication Pneumococcal disease Pathogen / Antigen
Last Verified 2026-10-30 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

Progress and adoption outlook

Where this candidate sits on a fixed development ladder, and when a licence and a routine-use recommendation could follow in each jurisdiction, as scenario bands. Input grade: Stage known from the trial registry only; no jurisdiction-specific filing date.

60% of the ladderC · registry only
  1. Preclinical
  2. Phase 1
  3. Phase 1/2
  4. Phase 2
  5. Phase 2/3
  6. Phase 3
  7. Submitted to a regulator
  8. Under regulatory review
  9. Approved / authorised
  10. Recommended for routine use

Current position: Phase 3

Status and projected windows by jurisdiction
JurisdictionStatus in the recordSubmissionRegulator decisionEarliest routine use
United StatesFDA (CBER) · ACIP (CDC)no jurisdiction-specific filing known2028-032027-09 to 2028-122029-012028-03 to 2030-032029-042028-03 to 2030-11
European UnionEMA (CHMP) and European Commission · national bodies (STIKO, HAS, Folkhälsomyndigheten and others)no jurisdiction-specific filing known2028-032027-09 to 2028-122029-052028-06 to 2030-082029-112028-07 to 2032-02
CanadaHealth Canada · NACIno jurisdiction-specific filing known2028-032027-09 to 2028-122029-012028-03 to 2030-032029-052028-04 to 2031-03
United KingdomMHRA · JCVIno jurisdiction-specific filing knownThe MHRA 150-day national assessment and International Recognition Procedure pages could not be fetched on 2026-10-24; no target is used.
AustraliaTGA · ATAGIno jurisdiction-specific filing knownTGA registration-timeframe pages timed out on 2026-10-24; no target is used.
JapanPMDA / MHLW · MHLW immunisation subcommitteeno jurisdiction-specific filing knownPMDA English pages reached on 2026-10-24 state that target review times exist but give no figure.
WHO prequalificationWHO Prequalification · SAGEno jurisdiction-specific filing knownWHO prequalification procedure pages returned 404/500 on 2026-10-24; no target is used.

Each window shows the typical scenario with the fast-to-slow band beneath it (year-month). Bands come from the parameters on the outlook model page; they are not forecasts.

Scientific Profile & Documentation

Platform Architecture
Conjugate vaccine
Lead Developer
Pfizer
Next Expected Milestone
Primary completion (most advanced trial): 2027-06-07 (registry estimate)
Analyst & Development Notes
Auto-grouped from 1 ClinicalTrials.gov record(s) sharing intervention/sponsor. Phases and timelines are registry fields and may lag company disclosures.
Primary Source Documentation
ClinicalTrials.gov NCT07794748 →

Registered Clinical Trials & Studies

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

NCT07794748 Phase 3 Clinical Trial

A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine

Status: Active / Ongoing • Expected Readout: 2027-06-07

Milestone Overview

  • Stage Verification
    Phase 3 Clinical Trial confirmed as of 2026-10-30.
  • Target Milestone
    Primary completion (most advanced trial): 2027-06-07 (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.