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Active, not recruiting Phase 2

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

NCT06720038 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2024-11-25
Last updated
2026-05-15

Condition(s) studied

Pneumococcal Vaccines

Investigational drug(s) / intervention(s)

0.5 mL of the low dose VAX-310.5 mL of the mid dose VAX-310.5 mL of the high dose VAX-310.5 mL dose of PCV20 →0.5 mL of the High-PFS dose VAX-31

0.5 mL of the low dose VAX-31: 31 valent pneumococcal conjugate vaccine

0.5 mL of the mid dose VAX-31: 31 valent pneumococcal conjugate vaccine

0.5 mL of the high dose VAX-31: 31 valent pneumococcal conjugate vaccine

0.5 mL dose of PCV20: 20 valent pneumococcal conjugate vaccine

0.5 mL of the High-PFS dose VAX-31: 31 valent pneumococcal conjugate vaccine

Study 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.

Eligibility

Sex
ALL
Min age
42 Days
Max age
89 Days
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination — 7 days after each vaccination
    Solicited local reactions include erythema, edema, and tenderness at the injection site
  • Percentage of subjects with any solicited systemic AE within 7 days after each vaccination — 7 days after each vaccination
    Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
  • Percentage of subjects with any unsolicited AE within 1 month after each vaccination — 1 months after each vaccination
    Percentage of subjects with unsolicited AE
  • Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination — 6 months after last vaccination
    Percentage of subjects with MAAE
  • Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination — 6 months after last vaccination
    Percentage of subjects with SAE
  • 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 NOCI

Trial sites (48)

FacilityCityRegionStatus
The Children's Clinic of Jonesboro, P.A Jonesboro Arkansas
Matrix Clinical Research Gardena California
Matrix Clinical Research Los Angeles California
Orange County Research Institute Ontario California
Center for Clinical Trials of San Gabriel West Covina California
Children's Hospital of Colorado - Dept. of Infectious Disease Aurora Colorado
SEC Clinical Research Pensacola Florida
PAS Research Tampa Florida
Clinical Research Prime, LLP Idaho Falls Idaho
Clinical Research Prime - Rexburg Rexburg Idaho
Kentucky Pediatrics/Adult Research Bardstown Kentucky
ACC Pediatric Research Haughton Louisiana
Complete Children's Health Lincoln Nebraska
Complete Children's Health Lincoln Nebraska
Be Well Clinical Studies Nebraska Lincoln Nebraska
Complete Children's Health Lincoln Nebraska
Complete Children's Health Lincoln Nebraska
Ohio Pediatric Research Association Dayton Ohio
Senders Pediatrics South Euclid Ohio
Cyn3rgy Research Gresham Oregon
UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry Cranberry Township Pennsylvania
Allegheny Health & Wellness Pavilion West Erie Pennsylvania
UPMC Children's Community Pediatrics - Norwin N. Huntingdon Pennsylvania
UPMC Children's Community Pediatrics South Hills-Jefferson Hills Pittsburgh Pennsylvania
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP) Pittsburgh Pennsylvania
UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill Pittsburgh Pennsylvania
UPMC Children's Community Pediatrics-Castle Shannon Pittsburgh Pennsylvania
Tribe Clinical Research, LLC dba Neighbors Clinical Research Charleston South Carolina
Tribe Clinical Research/Parkside Pediatrics Simpsonville South Carolina
Proactive RGV LLC Brownsville Texas
Javara Inc. /Texas Health Care, PLLC Dallas Texas
Oak Cliff Research Company Dallas Texas
Kool Kids Pediatrics (Dynamed) Houston Texas
Sunrise Pediatrics Houston Texas
Mercury Clinical Research - Pediatric Associates Houston Texas
University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program League City Texas
Pediatric Center/Neutra Life Sciences Richmond Texas
AMR - Layton Layton Utah
AMR - Cottonwood Murray Utah
AMR - Roy Roy Utah

+ 8 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06720038 on ClinicalTrials.gov ↗ ← All trials in the USA