A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
NCT ID: NCT06720038
Last Updated: 2026-01-26
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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ACTIVE_NOT_RECRUITING
PHASE2
905 participants
INTERVENTIONAL
2024-11-25
2027-12-31
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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VAX-31 High
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
0.5 mL of the high dose VAX-31
31 valent pneumococcal conjugate vaccine
PCV20
Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age.
0.5 mL dose of PCV20
20 valent pneumococcal conjugate vaccine
VAX-31 High-PFS
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
0.5 mL of the High-PFS dose VAX-31
31 valent pneumococcal conjugate vaccine
VAX-31 Low
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
0.5 mL of the low dose VAX-31
31 valent pneumococcal conjugate vaccine
VAX-31 Mid
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
0.5 mL of the mid dose VAX-31
31 valent pneumococcal conjugate vaccine
Interventions
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0.5 mL of the low dose VAX-31
31 valent pneumococcal conjugate vaccine
0.5 mL of the mid dose VAX-31
31 valent pneumococcal conjugate vaccine
0.5 mL of the high dose VAX-31
31 valent pneumococcal conjugate vaccine
0.5 mL dose of PCV20
20 valent pneumococcal conjugate vaccine
0.5 mL of the High-PFS dose VAX-31
31 valent pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
2. Full-term infant at least 37 weeks gestational age at birth.
3. Afebrile for ≥72 hours with an tympanic or rectal temperature \<38.0°C (\<100.4°F) before receipt of study vaccine.\*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours.
4. Able to attend all scheduled visits and comply with the study procedures.
5. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
6. Subject's parent/legal guardian is able to fill out an eDiary of solicited AE and take daily tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
7. Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.
Exclusion Criteria
2. Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine).
3. Known hypersensitivity to any vaccine.
4. Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
5. Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a \<14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted.
6. History of failure to thrive or prior hospitalization for any chronic condition.
7. Subject has a bleeding disorder contraindicating IM vaccination.
8. Subject or his/her mother has documented hepatitis B surface antigen-positive test.
9. Subject has a known neurologic or cognitive behavioral disorder.
10. Subject has a known clinically significant congenital malformation or serious chronic disorder.
11. Receipt of a blood transfusion or blood products, including immunoglobulins.
12. Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or plans to receive another investigational product while on study.
13. Any infant who cannot be adequately followed for safety according to the protocol plan.
14. Any other reason that in the opinion of the Investigator may interfere with the evaluation required by the study.
42 Days
89 Days
ALL
Yes
Sponsors
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Vaxcyte, Inc.
INDUSTRY
Responsible Party
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Locations
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The Children's Clinic of Jonesboro, P.A
Jonesboro, Arkansas, United States
Matrix Clinical Research
Gardena, California, United States
Matrix Clinical Research
Los Angeles, California, United States
Orange County Research Institute
Ontario, California, United States
Center for Clinical Trials of San Gabriel
West Covina, California, United States
Children's Hospital of Colorado - Dept. of Infectious Disease
Aurora, Colorado, United States
SEC Clinical Research
Pensacola, Florida, United States
PAS Research
Tampa, Florida, United States
Clinical Research Prime, LLP
Idaho Falls, Idaho, United States
Clinical Research Prime - Rexburg
Rexburg, Idaho, United States
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, United States
ACC Pediatric Research
Haughton, Louisiana, United States
Complete Children's Health
Lincoln, Nebraska, United States
Complete Children's Health
Lincoln, Nebraska, United States
Be Well Clinical Studies Nebraska
Lincoln, Nebraska, United States
Complete Children's Health
Lincoln, Nebraska, United States
Complete Children's Health
Lincoln, Nebraska, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, United States
Allegheny Health & Wellness Pavilion West
Erie, Pennsylvania, United States
UPMC Children's Community Pediatrics - Norwin
North Huntingdon, Pennsylvania, United States
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
Pittsburgh, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)
Pittsburgh, Pennsylvania, United States
UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
Pittsburgh, Pennsylvania, United States
UPMC Children's Community Pediatrics-Castle Shannon
Pittsburgh, Pennsylvania, United States
Tribe Clinical Research, LLC dba Neighbors Clinical Research
Charleston, South Carolina, United States
Tribe Clinical Research/Parkside Pediatrics
Simpsonville, South Carolina, United States
Proactive RGV LLC
Brownsville, Texas, United States
Javara Inc. /Texas Health Care, PLLC
Dallas, Texas, United States
Oak Cliff Research Company
Dallas, Texas, United States
Kool Kids Pediatrics (Dynamed)
Houston, Texas, United States
Sunrise Pediatrics
Houston, Texas, United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, United States
University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program
League City, Texas, United States
Pediatric Center/Neutra Life Sciences
Richmond, Texas, United States
AMR - Layton
Layton, Utah, United States
AMR - Cottonwood
Murray, Utah, United States
AMR - Roy
Roy, Utah, United States
AMR South Jordan
South Jordan, Utah, United States
AMR - Syracuse
Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Pediatric Research of Charlottesville, LLC
Gordonsville, Virginia, United States
Clinical Research Partners, LLC.
Richmond, Virginia, United States
Ponce Medical School Foundation Inc. / CAIMED Center
Ponce, , Puerto Rico
BRCR Global Puerto Rico
San Juan, , Puerto Rico
Caribbean Medical Research Center
San Juan, , Puerto Rico
Countries
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Other Identifiers
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VAX31-201
Identifier Type: -
Identifier Source: org_study_id
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