Recruiting

Phase 3

PG4 & 20vPnCA Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults

Sponsor:

Pfizer

Code:

NCT07794748

Conditions

Pneumococcal Disease

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

PG4 Multivalent Vaccine

PG4 Multivalent Vaccine

PG4 Multivalent Vaccine

20 Valent Pneumococcal Conjugate Vaccine (20vPnC)

Study Details

Brief 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.

Conditions

Pneumococcal Disease

Study ID

NCT07794748

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Jun 7, 2027

Anticipated

Primary completion date

Jun 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

4670 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PG4 Vaccine Lot 3

Multivalent Pneumococcal Vaccine

experimental: PG4 Vaccine Lot 2

Multivalent Pneumococcal Vaccine

experimental: PG4 Vaccine Lot 1

Multivalent Pneumococcal Vaccine

active comparator: 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)

20 Valent Pneumococcal Conjugate Vaccine

Interventions

PG4 Multivalent Vaccine

Multivalent Pneumococcal Vaccine

PG4 Multivalent Vaccine

Multivalent Pneumococcal Vaccine

PG4 Multivalent Vaccine

Multivalent Pneumococcal Vaccine

20 Valent Pneumococcal Conjugate Vaccine (20vPnC)

20 Valent Pneumococcal Conjugate Vaccine

Primary outcome measure

Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination [ Time Frame: Within 7 days after Vaccination ]
Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination [ Time Frame: Within 7 days after Vaccination ]
Percentage of Participants with Adverse Events (AEs) [ Time Frame: From Vaccination to 1 month after Vaccination ]
Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: From Vaccination to 6 months after Vaccination ]
OPA geometric mean ratios (GMR) between each pair of PG4 vaccine lots [ Time Frame: 1 month after Vaccination ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

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

Recruiting

Birmingham, Alabama, United States, 35216

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Diablo Clinical Research, LLC dba Flourish Research

Recruiting

Walnut Creek, California, United States, 94598

Clinical Research Consulting

Recruiting

Milford, Connecticut, United States, 06460

Suncoast Research Associates

Recruiting

Doral, Florida, United States, 33172

Research Centers of America

Recruiting

Hollywood, Florida, United States, 33024

East Coast Institute for Research, LLC

Recruiting

Jacksonville, Florida, United States, 32216

Entrust Clinical Research

Recruiting

Miami, Florida, United States, 33176

Palm Springs Community Health Center

Recruiting

Miami Lakes, Florida, United States, 33014

Indago Research and Health Center, Inc.

Recruiting

Miami Lakes, Florida, United States, 33016

Innovation Medical Research, LLC

Recruiting

Palmetto Bay, Florida, United States, 33157

Palm Beach Research Center

Recruiting

West Palm Beach, Florida, United States, 33409

Javara Inc.

Recruiting

Fayetteville, Georgia, United States, 30214

Clinical Research Atlanta

Recruiting

Stockbridge, Georgia, United States, 30281

East-West Medical Research Institute

Recruiting

Honolulu, Hawaii, United States, 96814

DM Clinical Research

Recruiting

Melrose Park, Illinois, United States, 60160

Velocity Clinical Research, Sioux City

Recruiting

Sioux City, Iowa, United States, 51106

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

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Clinical Research Professionals

Recruiting

Chesterfield, Missouri, United States, 63005

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Recruiting

Springfield, Missouri, United States, 65802

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

Recruiting

Springfield, Missouri, United States, 65807

Sundance Clinical Research, LLC

Recruiting

St Louis, Missouri, United States, 63141

Velocity Clinical Research, Grand Island

Recruiting

Grand Island, Nebraska, United States, 68803

South Jersey Infectious Disease

Recruiting

Somers Point, New Jersey, United States, 08244

Accellacare - Wilmington

Recruiting

Wilmington, North Carolina, United States, 28401

Cincinnati Children's Hospital Medical Center Investigational Drug Services

Recruiting

Cincinnati, Ohio, United States, 45206

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Recruiting

Cincinnati, Ohio, United States, 45206

CTI Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Clinical Trials of South Carolina

Recruiting

Moncks Corner, South Carolina, United States, 29461

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

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Coastal Carolina Research Center, LLC

Recruiting

North Charleston, South Carolina, United States, 29405

SMS Clinical Research LLC

Recruiting

Mesquite, Texas, United States, 75149

DM Clinical Research - Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

DM Clinical Research

Recruiting

Tomball, Texas, United States, 77375

J. Lewis Research, Inc. / Foothill Family Clinic

Recruiting

Salt Lake City, Utah, United States, 84109

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

Recruiting

Salt Lake City, Utah, United States, 84121

More Information

Sponsor

Pfizer

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.