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NCT07794748PHASE3RecruitingAccepts Healthy Volunteers

A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults

Pfizer

Start Date

9/8/2026

Completion Date

6/7/2027

Summary

The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine. This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines. The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC. Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC. Each participant will take part in the study for approximately 6 months.

Eligibility Criteria

Age Range: 18 years to 49 years

Inclusion Criteria: Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age. Exclusion Criteria: Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.

Interventions

BIOLOGICAL

PG4 Multivalent Vaccine

BIOLOGICAL

PG4 Multivalent Vaccine

BIOLOGICAL

PG4 Multivalent Vaccine

BIOLOGICAL

20 Valent Pneumococcal Conjugate Vaccine (20vPnC)

Interested in This Trial?

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Conditions

Pneumococcal Disease

Locations

Achieve Clinical Research, LLC d/b/a Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama 35216

United States

Orange County Research Center

Lake Forest, California 92630

United States

Diablo Clinical Research, LLC dba Flourish Research

Walnut Creek, California 94598

United States

Clinical Research Consulting

Milford, Connecticut 06460

United States

Suncoast Research Associates

Doral, Florida 33172

United States

Research Centers of America

Hollywood, Florida 33024

United States

East Coast Institute for Research, LLC

Jacksonville, Florida 32216

United States

Entrust Clinical Research

Miami, Florida 33176

United States

Palm Springs Community Health Center

Miami Lakes, Florida 33014

United States

Indago Research and Health Center, Inc.

Miami Lakes, Florida 33016

United States

Innovation Medical Research, LLC

Palmetto Bay, Florida 33157

United States

Palm Beach Research Center

West Palm Beach, Florida 33409

United States

Javara Inc.

Fayetteville, Georgia 30214

United States

Clinical Research Atlanta

Stockbridge, Georgia 30281

United States

East-West Medical Research Institute

Honolulu, Hawaii 96814

United States

DM Clinical Research

Melrose Park, Illinois 60160

United States

Velocity Clinical Research, Sioux City

Sioux City, Iowa 51106

United States

Henry Ford St. John Hospital - Thomas Mackey Center for Infectious Disease Research

Grosse Pointe Woods, Michigan 48236

United States

Clinical Research Professionals

Chesterfield, Missouri 63005

United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri 65802

United States

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

Springfield, Missouri 65807

United States

Sundance Clinical Research, LLC

St Louis, Missouri 63141

United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska 68803

United States

South Jersey Infectious Disease

Somers Point, New Jersey 08244

United States

Accellacare - Wilmington

Wilmington, North Carolina 28401

United States

Cincinnati Children's Hospital Medical Center Investigational Drug Services

Cincinnati, Ohio 45206

United States

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio 45206

United States

CTI Clinical Research Center

Cincinnati, Ohio 45212

United States

Clinical Trials of South Carolina

Moncks Corner, South Carolina 29461

United States

TMA Headlands LLC (d/b/a Trial Management Associates)

Myrtle Beach, South Carolina 29572

United States

Coastal Carolina Research Center, LLC

North Charleston, South Carolina 29405

United States

SMS Clinical Research LLC

Mesquite, Texas 75149

United States

DM Clinical Research - Sugar Land

Sugar Land, Texas 77478

United States

DM Clinical Research

Tomball, Texas 77375

United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah 84109

United States

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

Salt Lake City, Utah 84121

United States