ACTIVE_NOT_RECRUITING

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

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Conditions

Pneumococcal Vaccines31 Valent PCVPneumoniaPneumococcal Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-11-25
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06720038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:42 Days to 89 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Healthy male or female infant ≥42 days to ≤89 days.
  2. 2. Full-term infant at least 37 weeks gestational age at birth.
  3. 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. 4. Able to attend all scheduled visits and comply with the study procedures.
  5. 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. 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. 7. Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.
  1. 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. 2. Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine).
  3. 3. Known hypersensitivity to any vaccine.
  4. 4. Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
  5. 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. 6. History of failure to thrive or prior hospitalization for any chronic condition.
  7. 7. Subject has a bleeding disorder contraindicating IM vaccination.
  8. 8. Subject or his/her mother has documented hepatitis B surface antigen-positive test.
  9. 9. Subject has a known neurologic or cognitive behavioral disorder.
  10. 10. Subject has a known clinically significant congenital malformation or serious chronic disorder.
  11. 11. Receipt of a blood transfusion or blood products, including immunoglobulins.
  12. 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. 13. Any infant who cannot be adequately followed for safety according to the protocol plan.
  14. 14. Any other reason that in the opinion of the Investigator may interfere with the evaluation required by the study.

Contacts and Locations

Study Locations (Sites)

The Children's Clinic of Jonesboro, P.A
Jonesboro, Arkansas, 72401
United States
Matrix Clinical Research
Gardena, California, 90237
United States
Matrix Clinical Research
Los Angeles, California, 90057
United States
Orange County Research Institute
Ontario, California, 91762
United States
Center for Clinical Trials of San Gabriel
West Covina, California, 91790
United States
Children's Hospital of Colorado - Dept. of Infectious Disease
Aurora, Colorado, 80045
United States
SEC Clinical Research
Pensacola, Florida, 32503
United States
PAS Research
Tampa, Florida, 33613
United States
Clinical Research Prime, LLP
Idaho Falls, Idaho, 83404
United States
Clinical Research Prime - Rexburg
Rexburg, Idaho, 83440
United States
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, 40004
United States
ACC Pediatric Research
Haughton, Louisiana, 71037
United States
Complete Children's Health
Lincoln, Nebraska, 68504
United States
Complete Children's Health
Lincoln, Nebraska, 68505
United States
Be Well Clinical Studies Nebraska
Lincoln, Nebraska, 68516
United States
Complete Children's Health
Lincoln, Nebraska, 68516
United States
Complete Children's Health
Lincoln, Nebraska, 68522
United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414
United States
Senders Pediatrics
South Euclid, Ohio, 44121
United States
Cyn3rgy Research
Gresham, Oregon, 97030
United States
UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry
Cranberry Township, Pennsylvania, 16066
United States
Allegheny Health & Wellness Pavilion West
Erie, Pennsylvania, 16506
United States
UPMC Children's Community Pediatrics - Norwin
North Huntingdon, Pennsylvania, 15642
United States
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
Pittsburgh, Pennsylvania, 15025
United States
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)
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
Tribe Clinical Research, LLC dba Neighbors Clinical Research
Charleston, South Carolina, 29407
United States
Tribe Clinical Research/Parkside Pediatrics
Simpsonville, South Carolina, 29680
United States
Proactive RGV LLC
Brownsville, Texas, 78520
United States
Javara Inc. /Texas Health Care, PLLC
Dallas, Texas, 75001-
United States
Oak Cliff Research Company
Dallas, Texas, 75287
United States
Kool Kids Pediatrics (Dynamed)
Houston, Texas, 77065
United States
Sunrise Pediatrics
Houston, Texas, 77077
United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, 77087
United States
University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program
League City, Texas, 77573
United States
Pediatric Center/Neutra Life Sciences
Richmond, Texas, 77469
United States
AMR - Layton
Layton, Utah, 84041
United States
AMR - Cottonwood
Murray, Utah, 84107
United States
AMR - Roy
Roy, Utah, 84067
United States
AMR South Jordan
South Jordan, Utah, 84095
United States
AMR - Syracuse
Syracuse, Utah, 84075
United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
United States
Pediatric Research of Charlottesville, LLC
Gordonsville, Virginia, 22942
United States
Clinical Research Partners, LLC.
Richmond, Virginia, 23226
United States

Collaborators and Investigators

Sponsor: Vaxcyte, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • 31 Valent PCV
  • Pneumonia
  • Pneumococcal Infection

Additional Relevant MeSH Terms

  • Pneumococcal Vaccines