A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

Running, not enrolling · Phase 2

Conditions studied: Pneumococcal Vaccines

In brief

The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 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 approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.

Key facts

Study ID

NCT06720038

Run by

Vaxcyte, Inc.

People needed

900

Starts

2024-11-25

Expected to finish

2027-12-01

Last updated by the study team

2026-05-15

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.
• Full-term infant at least 37 weeks gestational age at birth.
• 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.
• 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 tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
• Subject's parent/legal guardian has an email 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 of hepatitis B vaccine).
• Known hypersensitivity to any vaccine.
• Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
• 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.
• History of failure to thrive or prior hospitalization for any chronic condition.
• Subject has a bleeding disorder contraindicating IM vaccination.
• Subject or his/her mother has documented hepatitis B surface antigen-positive test.
• Subject has a known neurologic or cognitive behavioral disorder.
• Subject 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 plans to receive another investigational product 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
• 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 — N. 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

Full record on ClinicalTrials.gov

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