VAX-31 + Influenza Vaccine for Pneumonia

Recruiting at 24 trial locations

Overseen By Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vaxcyte, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 month

1300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Adults aged 50 or older who are in good health or have stable chronic conditions can join this trial. They must be willing to give blood samples, use Wi-Fi or cellular devices for an eDiary, and follow up for 7 months. Women of childbearing age need a negative pregnancy test and must agree to contraception; men with such partners should also practice contraception.

Inclusion Criteria

I am willing to give blood for research.

I am 50 years old or older.

I can attend all follow-up visits for 7 months after my first vaccine dose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of VAX-31 and seasonal influenza vaccine at Day 1, followed by placebo or VAX-31 at Month 1

1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after receiving the vaccines

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VAX-31

Trial Overview

The study is testing the safety and immune response when giving VAX-31 (a pneumococcal vaccine) alongside a seasonal flu shot compared to separate administrations in adults over 50 who haven't had pneumococcal vaccines before.

How Is the Trial Designed?

Group I: VAX-31 + SIV Experimental Treatment 3 Interventions

Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1.

Group II: Placebo + SIV Experimental Treatment 3 Interventions

Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1.

Who Is Running the Clinical Trial?

Vaxcyte, Inc.

Lead Sponsor

Trials

5

Recruited

3,700+