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

NCT06720038
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
900
clinicaltrials.gov
Lead sponsor
Vaxcyte, Inc.
clinicaltrials.gov
Start date
2024-11-25
clinicaltrials.gov
Number of sites
48
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.
clinicaltrials.gov
Short title
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-12-01
clinicaltrials.gov
First posted
2024-12-06
clinicaltrials.gov
Registry last updated
2026-05-15
clinicaltrials.gov
Primary completion date
2027-12-01
clinicaltrials.gov
Start date
2024-11-25
clinicaltrials.gov

Actual participants
900
clinicaltrials.gov
Participants
900
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
8
clinicaltrials.gov
Number of sites
48
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Vaxcyte, Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06720038
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06720038
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination

    Timeframe: 7 days after each vaccination

    Solicited local reactions include erythema, edema, and tenderness at the injection site

  2. Percentage of subjects with any solicited systemic AE within 7 days after each vaccination

    Timeframe: 7 days after each vaccination

    Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep

  3. Percentage of subjects with any unsolicited AE within 1 month after each vaccination

    Timeframe: 1 months after each vaccination

    Percentage of subjects with unsolicited AE

  4. Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination

    Timeframe: 6 months after last vaccination

    Percentage of subjects with MAAE

  5. Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination

    Timeframe: 6 months after last vaccination

    Percentage of subjects with SAE

  6. Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination

    Timeframe: 6 months after last vaccination

    Percentage of subjects with NOCI

  1. Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL

  2. Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31

  3. Serotype-specific IgG antibody GMC 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
42 Days
Maximum age
89 Days
Healthy volunteers
Yes

  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.

  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.
Sources for eligibility
clinicaltrials.gov

  • The Children's Clinic of Jonesboro, P.AJonesboro, United States
  • Matrix Clinical ResearchGardena, United States
  • Matrix Clinical ResearchLos Angeles, United States
  • Orange County Research InstituteOntario, United States
  • Center for Clinical Trials of San GabrielWest Covina, United States
  • Children's Hospital of Colorado - Dept. of Infectious DiseaseAurora, United States
  • SEC Clinical ResearchPensacola, United States
  • PAS ResearchTampa, United States
  • Clinical Research Prime, LLPIdaho Falls, United States
  • Clinical Research Prime - RexburgRexburg, United States
  • Kentucky Pediatrics/Adult ResearchBardstown, United States
  • ACC Pediatric ResearchHaughton, United States
  • Complete Children's HealthLincoln, United States
  • Complete Children's HealthLincoln, United States
  • Be Well Clinical Studies NebraskaLincoln, United States
  • Complete Children's HealthLincoln, United States
  • Complete Children's HealthLincoln, United States
  • Ohio Pediatric Research AssociationDayton, United States
  • Senders PediatricsSouth Euclid, United States
  • Cyn3rgy ResearchGresham, United States
  • UPMC Children's Community Pediatrics - Bass Wolfson, CranberryCranberry Township, United States
  • Allegheny Health & Wellness Pavilion WestErie, United States
  • UPMC Children's Community Pediatrics - NorwinN. Huntingdon, United States
  • UPMC Children's Community Pediatrics South Hills-Jefferson HillsPittsburgh, United States
  • UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)Pittsburgh, United States

And 23 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (3)