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Cancer Vaccine

31-Valent Pneumococcal Vaccine for Preventing Pneumococcus-related Diseases

Phase 1 & 2
Waitlist Available
Research Sponsored by Vaxcyte, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 50 to 64 years (inclusive) for Stage 1, or 50 years and older (inclusive) for Stage 2 at the time of randomization into the study
Able to access and use a smartphone, tablet, computer, or other device connected to Wi-Fi or cellular network for completion of an electronic diary
Must not have
Receiving immunosuppressive therapy
Previous or existing diagnosis of HIV, Hepatitis B, or Hepatitis C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial tests the safety and effectiveness of a new vaccine in adults 50-64, compared to the existing Prevnar 20 vaccine.

Who is the study for?
Adults aged 50-64 for Stage 1, and 50+ for Stage 2, in good health with the ability to consent and follow-up. Must be willing to provide blood samples and use a smart device. Women must not be pregnant or breastfeeding and agree to contraception. Excludes those with previous pneumococcal disease/vaccine, recent investigational products, certain vaccines within a month before enrollment, acute illnesses, significant medical conditions including bleeding disorders or immunosuppression.
What is being tested?
The trial is testing the safety and immune response of VAX-31 (a new vaccine) against Prevnar 20™ (an existing vaccine). Participants will receive one injection of either VAX-31 at different doses or PCV20. The study has two stages based on age groups.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, general body reactions such as fever or fatigue, allergic responses ranging from mild rashes to more severe reactions like difficulty breathing if an allergy exists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 64 years old for Stage 1, or 50+ for Stage 2.
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I can use a smart device and have internet access for an e-diary.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication to suppress my immune system.
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I have been diagnosed with HIV, Hepatitis B, or Hepatitis C.
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I have a bleeding disorder that causes significant bruising or bleeding.
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I've been on corticosteroids for more than 14 days and stopped less than 30 days ago.
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I have had pneumococcal disease before.
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I have received a pneumococcal vaccine before.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3Experimental Treatment1 Intervention
Participants will receive a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
Group II: Group 2Experimental Treatment1 Intervention
Participants will receive a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
Group III: Group 1Experimental Treatment1 Intervention
Participants will receive a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
Group IV: Group 4Active Control1 Intervention
Participants will receive a single intramuscular injection of the standard dose of PCV20 at Day 1.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vaxcyte, Inc.Lead Sponsor
3 Previous Clinical Trials
1,842 Total Patients Enrolled
Clinical DevelopmentStudy DirectorVaxcyte, Inc.
36 Previous Clinical Trials
86,644 Total Patients Enrolled
~554 spots leftby Sep 2025
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