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NCT05844423 · ClinicalTrials.gov registry record · Phase 2

Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants

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

Completed
Registry status
Phase 2
Development phase
802
Enrollment target
20
Study locations

NCT05844423: Completed Phase 2 study of Pneumococcal Vaccines, sponsored by Vaxcyte.

NCT05844423 is a Phase 2 study of Pneumococcal Vaccines that has completed, run by Vaxcyte. The registered enrollment target is 802 participants, below the 1,426-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05844423, a Phase 2 study of Pneumococcal Vaccines, has completed, sponsored by Vaxcyte.

COMPLETED
Registry status
Phase 2
Development phase
802 participants
Enrollment target
20
Study locations

Study Summary

The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 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 the remainder of the sample size.

Primary Outcome

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

Conditions Studied

Pneumococcal Vaccines

Interventions

  • BIOLOGICAL 0.5 ml dose of 1.1 mcg VAX-24
  • BIOLOGICAL 0.5 ml dose of PCV20
  • BIOLOGICAL 0.5 ml dose of 2.2 mcg VAX-24
  • BIOLOGICAL 0.5 ml dose of 2.2/4.4 mcg VAX-24

Study Locations (20)

Pennsylvania

  • UPMC Bass Wolfson Cranberry - Cranberry Township
  • Allegheny Health and Wellness Pavilion - Erie
  • UPMC Children's Community Pediatrics South Hills-Jefferson Hills - Jefferson Hills
  • UPMC Primary Care Center Oakland - Pittsburgh
  • UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill - Pittsburgh
  • UPMC Children's Community Pediatrics-Castle Shannon - Pittsburgh

Nebraska

  • Meridian Clinical Research - Hastings
  • Midwest Children's Health Research Institute - Lincoln
  • Midwest Children's Health Research Institute - Lincoln
  • Midwest Children's Health Research Institute - Lincoln
  • Midwest Children's Health Research Institute - Lincoln

South Carolina

  • Palmetto Pediatrics, PA - North Charleston
  • Tribe Clinical Research at Parkside Pediatrics - Simpsonville
  • Coastal Pediatric Research - Summerville

Arkansas

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

California

  • Madera Family Medical Group - Madera

Florida

  • Jedidiah Clinical Research - Tampa

Kentucky

  • Kentucky Pediatric/ Adult Research - Bardstown

Louisiana

  • ACC Pediatric Research - Haughton

Trial Details

FieldValue
Enrollment Target 802 participants
Start Date 2023-03-29
Est. Completion 2025-08-25
Phase Phase 2
Vaxcyte

8 total trials

What the finished NCT05844423 record still lists

NCT05844423 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, below the 1,426-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (44% lower).

The record links to 1 condition, with Pneumococcal Vaccines appearing as the primary indexed condition, and to 4 interventions - of which 0.5 ml dose of 1.1 mcg VAX-24 is the first listed.

NCT05844423 names 20 study sites across 9 states, led by Pennsylvania, Nebraska, South Carolina.

Frequently Asked Questions

What is clinical trial NCT05844423 about?

NCT05844423 is a clinical study titled "Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants". The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 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. ...

What is the current status of trial NCT05844423?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 802 participants. The study started on 2023-03-29. Estimated completion is 2025-08-25.

What conditions does trial NCT05844423 study?

This clinical trial studies the following conditions: Pneumococcal Vaccines.

What interventions are being tested in trial NCT05844423?

The interventions under investigation include: 0.5 ml dose of 1.1 mcg VAX-24 (BIOLOGICAL), 0.5 ml dose of PCV20 (BIOLOGICAL), 0.5 ml dose of 2.2 mcg VAX-24 (BIOLOGICAL), 0.5 ml dose of 2.2/4.4 mcg VAX-24 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05844423?

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

Where is trial NCT05844423 being conducted?

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

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Related registry views

Source: ClinicalTrials.gov NCT05844423, the US trial registry maintained by the National Library of Medicine. NCT05844423 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.