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VAX-31 (adult)

Phase 3 Clinical Trial

Developer: Vaxcyte  |  Target Disease: Invasive pneumococcal disease (31-valent conjugate)

Category Resource

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

View Invasive pneumococcal disease (31-valent conjugate) Vaccine Guide →
Development Phase Phase 3 Clinical Trial Primary Status
Platform Technology Conjugate vaccine Biologic Architecture
Target Indication Invasive pneumococcal disease (31-valent conjugate) 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 Phase 3 Date: 2026
EMA (Europe) Not Filed / Pre-submission
Health Canada Not Filed / Pre-submission
TGA (Australia) Not Filed / Pre-submission

Scientific Profile & Documentation

Platform Architecture
Conjugate vaccine
Lead Developer
Vaxcyte
Next Expected Milestone
Topline data from OPUS-1 (company: Q4 2026); planned BLA submission to follow if positive
Analyst & Development Notes
One candidate program with multiple concurrent Phase 3 sub-studies — not three separate candidates.
Primary Source Documentation
Vaxcyte SEC exhibit / investor disclosure →

Registered Clinical Trials & Studies

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

VAX-31 (adult) Study Phase 3 Clinical Trial

OPUS-1

Status: Active / Ongoing • Comparator: standard-of-care PCVs • Expected Readout: Q4 2026
VAX-31 (adult) Study Phase 3 Clinical Trial

OPUS-2

Status: Active / Ongoing • Comparator: concomitant influenza vaccine, ages 50+ • Expected Readout: TBD
VAX-31 (adult) Study Phase 3 Clinical Trial

OPUS-3

Status: Active / Ongoing • Comparator: prior pneumococcal vaccine recipients • Expected Readout: TBD

Milestone Overview

  • Stage Verification
    Phase 3 Clinical Trial confirmed as of 2026-07-10.
  • Target Milestone
    Topline data from OPUS-1 (company: Q4 2026); planned BLA submission to follow if positive

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.