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ACTIVE NOT RECRUITING
NCT07086677
PHASE1

A Study to Learn About How a New Pneumococcal Vaccine Works in Adults

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: * an experimental PG4 vaccine * a PG4 vaccine comparator * a standard 20vPnC vaccine comparator * placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO DESCRIBE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS

Key Details

Gender

All

Age Range

65 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2025-07-22

Completion Date

2027-10-21

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

PG4 vaccine in Buffer 1 with low dose PA-001

Multivalent pneumococcal conjugate vaccine

BIOLOGICAL

PG4 in Buffer 1 with low dose PA-002

Multivalent pneumococcal conjugate vaccine

BIOLOGICAL

PG4 in Buffer 1 with high dose PA-001

Multivalent pneumococcal conjugate vaccine

BIOLOGICAL

PG4 vaccine in Buffer 1 with high dose PA-002

Multivalent pneumococcal conjugate vaccine

BIOLOGICAL

PG4 vaccine in Buffer 2

Multivalent pneumococcal conjugate vaccine

BIOLOGICAL

20-valent pneumococcal conjugate vaccine

(20vPnC)

BIOLOGICAL

Saline injection

Placebo

Locations (19)

Orange County Research Center

Lake Forest, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Finlay Medical Research

Greenacres City, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Johnson County Clinical Trials

Lenexa, Kansas, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center

Springfield, Missouri, United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Upstate Global Health Institute

East Syracuse, New York, United States

NYU Langone Health

New York, New York, United States

Duke Vaccine and Trials Unit

Durham, North Carolina, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Headlands Horizons, LLC dba Headlands Research-Brownsville

Brownsville, Texas, United States

Valley Regional Medical Center

Brownsville, Texas, United States

LabCorp

Houston, Texas, United States

IMA Clinical Research San Antonio

San Antonio, Texas, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Tomball, Texas, United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States