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NCT07284654 · ClinicalTrials.gov registry record · Phase 3

Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49

A Phase 3 study of Pneumococcal Vaccines, sponsored by Vaxcyte.

Recruiting
Registry status
Phase 3
Development phase
4,000
Enrollment target
20
Study locations

NCT07284654: Recruiting Phase 3 study of Pneumococcal Vaccines, sponsored by Vaxcyte.

NCT07284654 is a Phase 3 study of Pneumococcal Vaccines that is actively recruiting participants, run by Vaxcyte. The registered enrollment target is 4,000 participants, above the 787-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (408% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07284654, a Phase 3 study of Pneumococcal Vaccines, is actively recruiting participants, sponsored by Vaxcyte.

RECRUITING
Registry status
Phase 3
Development phase
4,000 participants
Enrollment target
20
Study locations

Study Summary

The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.

Conditions Studied

Interventions

  • BIOLOGICAL PCV21
  • BIOLOGICAL 31 valent pneumococcal conjugate vaccine
  • BIOLOGICAL PCV20

Study Locations (20)

Florida

  • Research Centers of America - Hollywood - CenExel - Hollywood
  • Health Awareness - Jupiter - ERN - Jupiter
  • Suncoast Research Group LLC - Miami
  • Precision Clinical Research - Sunrise - Sunrise

Arizona

  • Center for Indigenous Health - Chinle - Johns Hopkins Project - Chinle
  • Center for Indigineous Health - Whiteriver - John Hopkins Project - Whiteriver

Kansas

  • Johnson County Clin-Trials - JCCT - Lenexa
  • Alliance for Multispecialty Research, LLC - West Wichita - Wichita

Mississippi

  • DelRicht Research, LLC - Gulfport - Gulfport
  • Sky Integrative Medical Center - SKYCRNG - Ridgeland

Alabama

  • Accel Research Site - Achieve - Birmingham - ERN - Birmingham

California

  • Clinical Innovations Trials - Riverside - CenExel - Riverside

Georgia

  • Clinical Research Atlanta - Headlands - Stockbridge

Indiana

  • Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - Valparaiso

Trial Details

FieldValue
Enrollment Target 4,000 participants
Start Date 2025-12-01
Est. Completion 2027-01
Phase Phase 3
Vaxcyte

8 total trials

What NCT07284654 shows while recruiting

NCT07284654 is an interventional study that assigns participants to a tested intervention. Its 4,000 participants enrollment target places it among the larger protocols in the corpus, above the 787-participant average among 5 other Pneumococcal Vaccines trials with a reported enrollment target (408% higher).

The record links to 1 condition, with Pneumococcal Vaccines appearing as the primary indexed condition, and to 3 interventions - of which PCV21 is the first listed.

NCT07284654 names 20 study sites across 14 states, led by Florida, Arizona, Kansas.

Frequently Asked Questions

What is clinical trial NCT07284654 about?

NCT07284654 is a clinical study titled "Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49". The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in...

What is the current status of trial NCT07284654?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,000 participants. The study started on 2025-12-01. Estimated completion is 2027-01.

What conditions does trial NCT07284654 study?

This clinical trial studies the following conditions: Pneumococcal Vaccines.

What interventions are being tested in trial NCT07284654?

The interventions under investigation include: PCV21 (BIOLOGICAL), 31 valent pneumococcal conjugate vaccine (BIOLOGICAL), PCV20 (BIOLOGICAL).

Who is sponsoring clinical trial NCT07284654?

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

Where is trial NCT07284654 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT07284654, the US trial registry maintained by the National Library of Medicine. NCT07284654 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.