Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults
NCT ID: NCT06151288
Last Updated: 2025-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
1015 participants
INTERVENTIONAL
2023-11-08
2024-07-17
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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Group 1
Participants received a single low dose of VAX-31 administered as an intramuscular injection at Day 1.
1.1 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 1.65 mcg.
31 valent pneumococcal conjugate vaccine
0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1
Group 2
Participants received a single mid dose of VAX-31 administered as an intramuscular injection at Day 1.
2.2 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 3.3 mcg.
31 valent pneumococcal conjugate vaccine
0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1
Group 3
Participants received a single high dose of VAX-31 administered as an intramuscular injection at Day 1.
3.3 mcg for all serotypes with the exception of serotypes 1, 5, and 22F which is 4.4 mcg.
31 valent pneumococcal conjugate vaccine
0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1
Group 4
Participants received a single intramuscular injection of the standard dose of PCV20 at Day 1.
20 valent pneumococcal conjugate vaccine
0.5 ml dose of PCV20 was administered into the deltoid muscle at Day 1
Interventions
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31 valent pneumococcal conjugate vaccine
0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1
20 valent pneumococcal conjugate vaccine
0.5 ml dose of PCV20 was administered into the deltoid muscle at Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able and willing to complete the informed consent process.
3. Available for clinical follow-up through the last study visit at 6 months after the study vaccination.
4. In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the Investigator.
5. Willing to have blood samples collected, stored indefinitely, and used for research purposes.
6. Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.
7. Women 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
8. 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.
Exclusion Criteria
2. Previous receipt of a licensed or investigational pneumococcal vaccine.
3. Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
4. Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Month 1.
5. Physical examination indicating any clinically significant medical condition.
6. Body Temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).
7. Previous or existing diagnosis of HIV, Hepatitis B, or Hepatitis C.
8. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
9. Female who is pregnant, breastfeeding, or planning to become pregnant during study participation.
10. 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.
11. Any other chronic or clinically significant medical condition that, in the opinion of the Investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.
12. 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.
13. Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.
14. Received systemic corticosteroids (except for inhaled, topical, intra-articular) for
≥14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.
15. Receiving immunosuppressive therapy.
16. History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
50 Years
ALL
Yes
Sponsors
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Vaxcyte, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Vaxcyte, Inc.
Locations
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AMR Mobile
Mobile, Alabama, United States
AMR Phoenix
Phoenix, Arizona, United States
Research Centers of America
Hollywood, Florida, United States
Health Awareness
Jupiter, Florida, United States
Optimal Research
Melbourne, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
DM Clinical Research - Detroit
Detroit, Michigan, United States
Velocity Clinical Research Omaha
Omaha, Nebraska, United States
WR-CRCN
Las Vegas, Nevada, United States
Cenexel AMRI
Toms River, New Jersey, United States
Rochester Clinical Research
Rochester, New York, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Velocity Clinical Research, Cleveland
Cleveland, Ohio, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
Velocity Clinical Research
Warwick, Rhode Island, United States
Coastal Carolina Research
North Charleston, South Carolina, United States
AMR Knoxville
Knoxville, Tennessee, United States
Benchmark Research
Fort Worth, Texas, United States
Benchmark Research
San Angelo, Texas, United States
CenExel JBR Clinical Research
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VAX31-101
Identifier Type: -
Identifier Source: org_study_id
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