Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
NCT ID: NCT07284654
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
4000 participants
INTERVENTIONAL
2025-12-01
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cohort 1 (VAX-31), participant ≥ 50 years of age
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1
31 valent pneumococcal conjugate vaccine
0.5 mL of VAX-31 will be administered into the deltoid muscle
Cohort 1 (PCV21), participant ≥ 50 years of age
Participants will receive a single dose of PCV21 (Capvaxive) administered via intramuscular injection at Day 1
PCV21
0.5 mL of the 21 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Cohort 1 (PCV20), participant ≥ 50 years of age
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1
PCV20
0.5 mL of the 20 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Cohort 2 (VAX-31), participant 18-49 years of age
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1
31 valent pneumococcal conjugate vaccine
0.5 mL of VAX-31 will be administered into the deltoid muscle
Cohort 2 (PCV20), participant 18-49 years of age
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1
PCV20
0.5 mL of the 20 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Interventions
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31 valent pneumococcal conjugate vaccine
0.5 mL of VAX-31 will be administered into the deltoid muscle
PCV20
0.5 mL of the 20 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
PCV21
0.5 mL of the 21 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to complete the informed consent process.
* Available for clinical follow-up through the last study visit.
* 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.
* Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process.
* Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method.
* Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
Exclusion Criteria
* Previous receipt of any licensed or investigational pneumococcal vaccine at any age.
* Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
* Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1.
* Body temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened).
* Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C.
* History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
* Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
* Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
* Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
* Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to enrollment into the study.
* Is currently receiving immunosuppressive or immune-modifying therapy, including systemic corticosteroids (this includes ≥3 months of prednisone equivalent from 5 to \<10 mg/day and ≥2 weeks of prednisone equivalent ≥10 mg/day).
* Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent \>10 mg/day) within 14 days of study vaccination.
* History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
* Employee of, or first-degree relative of, any person employed by the Sponsor, the contract research organization (CRO), the Investigator, site personnel, or site.
18 Years
ALL
Yes
Sponsors
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Vaxcyte, Inc.
INDUSTRY
Responsible Party
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Locations
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Accel Research Site - Achieve - Birmingham - ERN
Birmingham, Alabama, United States
Center for Indigenous Health - Chinle - Johns Hopkins Project
Chinle, Arizona, United States
Center for Indigineous Health - Whiteriver - John Hopkins Project
Whiteriver, Arizona, United States
Clinical Innovations Trials - Riverside - CenExel
Riverside, California, United States
Research Centers of America - Hollywood - CenExel
Hollywood, Florida, United States
Health Awareness - Jupiter - ERN
Jupiter, Florida, United States
Suncoast Research Group LLC
Miami, Florida, United States
Precision Clinical Research - Sunrise
Sunrise, Florida, United States
Clinical Research Atlanta - Headlands
Stockbridge, Georgia, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
Valparaiso, Indiana, United States
Johnson County Clin-Trials - JCCT
Lenexa, Kansas, United States
Alliance for Multispecialty Research, LLC - West Wichita
Wichita, Kansas, United States
DelRicht Clinical Research, LLC - New Orleans
New Orleans, Louisiana, United States
Headlands Research - Detroit - Headlands
Southfield, Michigan, United States
DelRicht Research, LLC - Gulfport
Gulfport, Mississippi, United States
Sky Integrative Medical Center - SKYCRNG
Ridgeland, Mississippi, United States
Alliance for Multispecialty Research, LLC - Kansas City
Kansas City, Missouri, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Advanced Memory Research Institute - CenExe
Toms River, New Jersey, United States
Center for Indigineous Health - Gallup - John Hopkins Project
Gallup, New Mexico, United States
Center for Indigineous Health - Shiprock - John Hopkins Project
Shiprock, New Mexico, United States
Rochester Clinical Research - ATLAS - Rochester
Rochester, New York, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center - Alcanza - HyperCore
North Charleston, South Carolina, United States
Flourish Research - San Antonio
San Antonio, Texas, United States
DM Clinical Research - Sugarland
Sugar Land, Texas, United States
JBR Clinical Research - CenExel JBR
Salt Lake City, Utah, United States
Charlottesville Medical Research Center - Alcanza - HyperCore
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VAX31-103
Identifier Type: -
Identifier Source: org_study_id