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

NCT07365826 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1390

Last updated 2026-05-15

No results posted yet for this 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

BIOLOGICAL

31-valent pneumococcal conjugate vaccine

0.5 mL of VAX-31 will be administered into the deltoid muscle

BIOLOGICAL

Seasonal Influenza Vaccine (SIV) (Flublok)

0.5 mL of SIV into the deltoid muscle

BIOLOGICAL

Placebo

0.5mL of placebo (normal saline) into the deltoid muscle

Sponsors & Collaborators

  • Vaxcyte, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07365826 on ClinicalTrials.gov