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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 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.

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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.

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

Sponsor

Vaxcyte

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06720038

The ClinicalTrials.gov registry entry for NCT06720038 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 905 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,406-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (36% lower). The listed sponsor is Vaxcyte, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.