Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With Pediatric Vaccines
1 other identifier
interventional
802
1 country
32
Brief Summary
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2023
CompletedFirst Submitted
Initial submission to the registry
April 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2025
CompletedSeptember 11, 2025
September 1, 2025
2.4 years
April 24, 2023
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination
Solicited local reactions include erythema, edema, and tenderness at the injection site
7 days after each vaccination
Percentage of participants with any solicited systemic AE within 7 days after each vaccination
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
7 days after each vaccination
Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination
Percentage of participants with related SAE
6 months after last vaccination
Secondary Outcomes (16)
Percentage of subjects with any unsolicited AE within 1 month after each vaccination
1 month after each vaccination
Percentage of subjects with any unsolicited AE from Dose 1 through 1 month post-Dose 3
First vaccination (Dose 1) through 1 month after third vaccination (Dose 3)
Percentage of subjects with any AE resulting in discontinuation of study within 6 months after last vaccination
6 months after last vaccination
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
6 months after last vaccination
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
6 months after last vaccination
- +11 more secondary outcomes
Study Arms (4)
VAX-24 Low
EXPERIMENTALParticipants 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.
VAX-24 Mid
EXPERIMENTALParticipants 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.
VAX-24 Mixed
EXPERIMENTALParticipants 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.
PCV20
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male or female infant ≥42 days to ≤89 days (inclusive).
- Full-term infant at least 37 weeks gestational age at birth.
- 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.\*
- Able to attend all scheduled visits and comply with the study procedures.
- Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
- 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.
- Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.
You may not qualify if:
- History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
- Known hypersensitivity to any vaccine.
- Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
- Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
- History of failure to thrive.
- Subject has a coagulation disorder contraindicating IM vaccination.
- Subject or his/her mother have documented hepatitis B surface antigen-positive.
- Has a known neurologic or cognitive behavioral disorder.
- Has a known clinically significant congenital malformation or serious chronic disorder.
- Receipt of a blood transfusion or blood products, including immunoglobulins.
- 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.
- Any infant who cannot be adequately followed for safety according to the protocol plan.
- Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vaxcyte, Inc.lead
Study Sites (32)
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Madera Family Medical Group
Madera, California, 93637, United States
Jedidiah Clinical Research
Tampa, Florida, 33617, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004, United States
ACC Pediatric Research
Haughton, Louisiana, 71037, United States
Meridian Clinical Research
Hastings, Nebraska, 68901, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68505, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68516, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68522, United States
Ohio Pediatric Research Assn.
Dayton, Ohio, 45414, United States
UPMC Bass Wolfson Cranberry
Cranberry Township, Pennsylvania, 16066, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506, United States
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
Jefferson Hills, Pennsylvania, 15025, United States
UPMC Primary Care Center Oakland
Pittsburgh, Pennsylvania, 15213, United States
UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
Pittsburgh, Pennsylvania, 15217, United States
UPMC Children's Community Pediatrics-Castle Shannon
Pittsburgh, Pennsylvania, 15234, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, 29406, United States
Tribe Clinical Research at Parkside Pediatrics
Simpsonville, South Carolina, 29680, United States
Coastal Pediatric Research
Summerville, South Carolina, 29486, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Ventavia Research Group
Burleson, Texas, 76028, United States
Ventavia
Houston, Texas, 77008, United States
Kool Kids Pediatrics
Houston, Texas, 77065, United States
Pediatric Associates
Houston, Texas, 77087, United States
Pediatric Center
Richmond, Texas, 77469, United States
Alliance for Multispecialty Research
Layton, Utah, 84041, United States
Alliance for Multispecialty Research
Murray, Utah, 84107, United States
Alliance for Multispecialty Research
Provo, Utah, 84604, United States
Alliance for Multispecialty Research
Roy, Utah, 84067, United States
Alliance for Multispecialty Research
Syracuse, Utah, 84075, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Triple (Participant, Investigator, Outcomes Assessor)
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 6, 2023
Study Start
March 29, 2023
Primary Completion
August 25, 2025
Study Completion
August 25, 2025
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.
- Access Criteria
- Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.
Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.