drugset
Drugs / VAX-31
last change 6 days ago re-read 9 days ago

VAX-31

Vaccine

Investigated by
Vaxcyte, Inc.

Trials 5

today NCT07425392 · Ph 3 NCT07365826 · Ph 3 NCT07284654 · Ph 3 NCT06720038 · Ph 2 NCT06151288 · Ph 1/2
20242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial · 1 met primary
Phase 1/2 NCT06151288 Nov 2023 → Jul 2024 — Vaxcyte, Inc. Completed Met primary
Phase 21 trial
Phase 2 NCT06720038 Nov 2024 → Dec 2027 expected — Vaxcyte, Inc. Active not recruiting No outcome recorded
Phase 33 trials · 1 met primary
Phase 3 NCT07425392 Feb 2026 → Mar 2027 expected — Vaxcyte, Inc. Active not recruiting No outcome recorded
Phase 3 NCT07365826 Jan 2026 → Mar 2027 expected — Vaxcyte, Inc. Active not recruiting No outcome recorded
Phase 3 NCT07284654 Dec 2025 → Jan 2027 expected — Vaxcyte, Inc. Active not recruiting Met primary

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2026-10-05 Vaxcyte, Inc. Results Vaxcyte Reports Positive Topline Data from OPUS-1, the Pivotal Adult Phase 3 Trial of VAX-31, the Company’s 31-Valent Pneumococcal Conjugate Vaccine Candidate vaxcyte.com ↗
VAX-31 Met All Prespecified Primary Endpoints Across Age Groups Studied Compared to Prevnar 20 ® (PCV20) and/or Capvaxive ® (PCV21)
2026-03-18 Vaxcyte, Inc. Results Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte’s 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate vaxcyte.com ↗
2024-11-12 Vaxcyte, Inc. Regulatory Vaxcyte Provides Positive Regulatory Updates on VAX-31 Pediatric and Adult Programs vaxcyte.com ↗
VAX-31 Infant Indication: Investigational New Drug Application Cleared by FDA
2024-09-03 Vaxcyte, Inc. Results Vaxcyte Reports Positive Topline Data from Phase 1/2 Study of VAX-31, its 31-Valent Pneumococcal Conjugate Vaccine Candidate, in Adults Aged 50 and Older vaxcyte.com ↗
VAX-31 showed robust opsonophagocytic activity (OPA) immune responses for all 31 serotypes at all doses studied.
2023-10-19 Vaxcyte, Inc. Regulatory Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-31 for the Prevention of Invasive Pneumococcal Disease in Adults vaxcyte.com ↗

All press releases naming this drug 18 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as VAX-31 “Safety, tolerability, and immunogenicity of a 31-valent pneumococcal conjugate vaccine (VAX-31) in healthy adults aged 50 years and older from the USA: a phase 1/2,...” PMID 41864214 ↗ Mar 2026
4

“Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1” NCT07365826 ↗

“Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1” NCT07425392 ↗

“0.5 mL of VAX-31 will be administered into the deltoid muscle” NCT07284654 ↗

NCT06720038 ↗
Modality Vaccine “VAX-31, a 31-valent PCV candidate designed to provide broad serotype coverage and higher immunogenicity.” PMID 41864214 ↗ Mar 2026
Route Intramuscular “Participants were block randomised (1:1:1:1) using a web-based randomisation and trial management system to receive a dose of intramuscular low-dose, mid-dose, or high-dose...” PMID 41864214 ↗ Mar 2026