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NCT06720038 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Pneumococcal Vaccines, sponsored by Vaxcyte.

Active
Registry status
Phase 2
Development phase
905
Enrollment target
20
Study locations

NCT06720038: Active Phase 2 study of Pneumococcal Vaccines, sponsored by Vaxcyte.

NCT06720038 is a Phase 2 study of Pneumococcal Vaccines that is active but no longer recruiting, run by Vaxcyte. The registered enrollment target is 905 participants, below the 1,406-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06720038, a Phase 2 study of Pneumococcal Vaccines, is active but no longer recruiting, sponsored by Vaxcyte.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
905 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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

Conditions Studied

Pneumococcal Vaccines

Interventions

  • BIOLOGICAL 0.5 mL of the low dose VAX-31
  • BIOLOGICAL 0.5 mL of the mid dose VAX-31
  • BIOLOGICAL 0.5 mL of the high dose VAX-31
  • BIOLOGICAL 0.5 mL dose of PCV20
  • BIOLOGICAL 0.5 mL of the High-PFS dose VAX-31

Study Locations (20)

Nebraska

  • Complete Children's Health - Lincoln
  • Complete Children's Health - Lincoln
  • Be Well Clinical Studies Nebraska - Lincoln
  • Complete Children's Health - Lincoln
  • Complete Children's Health - Lincoln

California

  • Matrix Clinical Research - Gardena
  • Matrix Clinical Research - Los Angeles
  • Orange County Research Institute - Ontario
  • Center for Clinical Trials of San Gabriel - West Covina

Florida

  • SEC Clinical Research - Pensacola
  • PAS Research - Tampa

Idaho

  • Clinical Research Prime, LLP - Idaho Falls
  • Clinical Research Prime - Rexburg - Rexburg

Ohio

  • Ohio Pediatric Research Association - Dayton
  • Senders Pediatrics - South Euclid

Arkansas

  • The Children's Clinic of Jonesboro, P.A - Jonesboro

Colorado

  • Children's Hospital of Colorado - Dept. of Infectious Disease - Aurora

Kentucky

  • Kentucky Pediatrics/Adult Research - Bardstown

Trial Details

FieldValue
Enrollment Target 905 participants
Start Date 2024-11-25
Est. Completion 2027-12
Phase Phase 2
Vaxcyte

8 total trials

What the registry record for NCT06720038 still lists

NCT06720038 is an interventional study that assigns participants to a tested intervention. The registered 905 participants enrollment target is mid-sized for trials with a published cap, below the 1,406-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (36% lower).

The record links to 1 condition, with Pneumococcal Vaccines appearing as the primary indexed condition, and to 5 interventions - of which 0.5 mL of the low dose VAX-31 is the first listed.

NCT06720038 names 20 study sites across 10 states, led by Nebraska, California, Florida.

Frequently Asked Questions

What is clinical trial NCT06720038 about?

NCT06720038 is a clinical study titled "A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants". 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 as...

What is the current status of trial NCT06720038?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 905 participants. The study started on 2024-11-25. Estimated completion is 2027-12.

What conditions does trial NCT06720038 study?

This clinical trial studies the following conditions: Pneumococcal Vaccines.

What interventions are being tested in trial NCT06720038?

The interventions under investigation include: 0.5 mL of the low dose VAX-31 (BIOLOGICAL), 0.5 mL of the mid dose VAX-31 (BIOLOGICAL), 0.5 mL of the high dose VAX-31 (BIOLOGICAL), 0.5 mL dose of PCV20 (BIOLOGICAL), 0.5 mL of the High-PFS dose VAX-31 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06720038?

This trial is sponsored by Vaxcyte, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06720038 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT06720038, the US trial registry maintained by the National Library of Medicine. NCT06720038 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.