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720 Participants NeededMy employer runs this trial

VAX-31 for Pneumococcal Infections

Recruiting at 29 trial locations
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 GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will evaluate the safety, tolerability, and immunogenicity of VAX-31 in adults ≥50 years of age.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 50 years old or older.
* In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
* Willing to have blood samples collected and used for research purposes.
See 6 more

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 or PCV20 administered via intramuscular injection at Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity after receiving the vaccine

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VAX-31

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combinationExperimental Treatment1 Intervention
Group II: Cohort 2 (VAX-31): Prior PCV20Experimental Treatment1 Intervention
Group III: Cohort 1 (VAX-31): Prior PPSV23Experimental Treatment1 Intervention
Group IV: Cohort 1 (PCV20): Prior PPSV23Active Control1 Intervention
Group V: Cohort 2 (PCV20): Prior PCV20Active Control1 Intervention
Group VI: Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combinationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vaxcyte, Inc.

Lead Sponsor

Trials
5
Recruited
3,700+

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