Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
NCT ID: NCT05844423
Last Updated: 2025-09-11
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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COMPLETED
PHASE2
802 participants
INTERVENTIONAL
2023-03-29
2025-08-25
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-24 Low
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
0.5 ml dose of 1.1 mcg VAX-24
24 valent pneumococcal conjugate vaccine
VAX-24 Mid
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
0.5 ml dose of 2.2 mcg VAX-24
24 valent pneumococcal conjugate vaccine
VAX-24 Mixed
Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
0.5 ml dose of 2.2/4.4 mcg VAX-24
24 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
Interventions
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0.5 ml dose of 1.1 mcg VAX-24
24 valent pneumococcal conjugate vaccine
0.5 ml dose of PCV20
20 valent pneumococcal conjugate vaccine
0.5 ml dose of 2.2 mcg VAX-24
24 valent pneumococcal conjugate vaccine
0.5 ml dose of 2.2/4.4 mcg VAX-24
24 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 a rectal temperature \<38.0°C (\<100.4°F) or axillary temperature \<37.8°C (\<100.0°F) before receipt of study vaccine.\*
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 axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
7. Subject's parent/legal guardian has an e-mail 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 hepatitis B vaccine).
3. Known hypersensitivity to any vaccine.
4. Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
5. Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
6. History of failure to thrive.
7. Subject has a coagulation disorder contraindicating IM vaccination.
8. Subject or his/her mother have documented hepatitis B surface antigen-positive.
9. Has a known neurologic or cognitive behavioral disorder.
10. 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 having plans to receive another investigational product(s) 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
Madera Family Medical Group
Madera, California, United States
Jedidiah Clinical Research
Tampa, Florida, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
ACC Pediatric Research
Haughton, Louisiana, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Ohio Pediatric Research Assn.
Dayton, Ohio, United States
UPMC Bass Wolfson Cranberry
Cranberry Township, Pennsylvania, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
Jefferson Hills, Pennsylvania, United States
UPMC Primary Care Center Oakland
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
Palmetto Pediatrics, PA
North Charleston, South Carolina, United States
Tribe Clinical Research at Parkside Pediatrics
Simpsonville, South Carolina, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Ventavia Research Group
Burleson, Texas, United States
Ventavia
Houston, Texas, United States
Kool Kids Pediatrics
Houston, Texas, United States
Pediatric Associates
Houston, Texas, United States
Pediatric Center
Richmond, Texas, United States
Alliance for Multispecialty Research
Layton, Utah, United States
Alliance for Multispecialty Research
Murray, Utah, United States
Alliance for Multispecialty Research
Provo, Utah, United States
Alliance for Multispecialty Research
Roy, Utah, United States
Alliance for Multispecialty Research
Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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VAX24-112
Identifier Type: -
Identifier Source: org_study_id
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