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NCT07365826Phase 3ACTIVE NOT RECRUITING

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age

Study Summary

This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.

Conditions
Pneumococcal Vaccines
Interventions / Drugs
31-valent pneumococcal conjugate vaccineSeasonal Influenza Vaccine (SIV) (Flublok)Placebo
View on ClinicalTrials.gov ↗
Sponsor
PCVX
Vaxcyte Inc
Vaccines
D37/100
Study Details
Enrollment1390 participants
Primary Completion—
Lead SponsorVaxcyte, Inc.
Data Retrieved2026-04-11 04:24:14.205331+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 1,390 participants
Sponsor Catalyst Profile

Vaxcyte Inc (PCVX) is the sponsoring company for this trial. BiotechSign currently grades this company D (37/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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