Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants

Completed · Phase 2

Conditions studied: Pneumococcal Vaccines

In brief

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.

Key facts

Study ID

NCT05844423

Run by

Vaxcyte, Inc.

People needed

802

Starts

2023-03-29

Expected to finish

2025-08-25

Last updated by the study team

2025-09-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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