Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06720038

PHASE2

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

Sponsor: Vaxcyte, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines

Key Details

Gender

All

Age Range

42 Days - 89 Days

Study Type

INTERVENTIONAL

Enrollment

905

Start Date

2024-11-25

Completion Date

2027-12

Last Updated

2026-01-26

Healthy Volunteers

Yes

Conditions

Pneumococcal Vaccines

Interventions

BIOLOGICAL

0.5 mL of the low dose VAX-31

31 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL of the mid dose VAX-31

31 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL of the high dose VAX-31

31 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL dose of PCV20

20 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL of the High-PFS dose VAX-31

31 valent pneumococcal conjugate vaccine

Inclusion Criteria: 1. Healthy male or female infant ≥42 days to ≤89 days. 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: 1. 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. 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.

Locations (48)

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