Recruiting
Phase 3

PG4

Sponsor:

Pfizer

Code:

NCT07629440

Conditions

Pneumococcal Disease

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

PG4

20-valent pneumococcal conjugate vaccine (20vPnC)

Study Details

Brief summary:

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines.

To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.

There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are:

  • infants who are 2 months of age in Group 1;
  • infants who are 2 to 6 months of age in Groups 2 and 3; and
  • said to be healthy by the study doctor

About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.

About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.

About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.

Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Infants will have 3 blood samples collected.

Conditions

Pneumococcal Disease

Study ID

NCT07629440

Start date

May 29, 2026

Status verified date

Jul, 2026

Completion date

Jun 5, 2029

Anticipated

Primary completion date

Jun 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

  • infants who are 2 months of age in Group 1.
  • infants who are 2 to 6 months of age in Groups 2 and 3.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
  • Major known congenital malformation or serious chronic disorder.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Study Design

Enrollment

3230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1 PG4 (intramuscular)

Multivalent Pneumococcal Vaccine

active comparator: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)

20-valent pneumococcal conjugate vaccine (20vPnC)

experimental: Group 2 PG4 (intramuscular)

Multivalent Pneumococcal Vaccine

active comparator: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)

20-valent pneumococcal conjugate vaccine (20vPnC)

experimental: Group 3 PG4 (intramuscular)

Multivalent Pneumococcal Vaccine

experimental: Group 3 PG4 (subcutaneous)

Multivalent Pneumococcal Vaccine

active comparator: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)

20-valent pneumococcal conjugate vaccine (20vPnC)

Interventions

PG4

Multivalent Pneumococcal Vaccine

20-valent pneumococcal conjugate vaccine (20vPnC)

20-valent pneumococcal conjugate vaccine (20vPnC)

Primary outcome measure

  • Percentage of participants reporting local reactions within 7 days after each dose [ Time Frame: Day 7 ]
  • Percentage of participants reporting systemic events within 7 days after each dose [ Time Frame: Day 7 ]
  • Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 [ Time Frame: Dose 1 to 1 month after Dose 3 ]
  • Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 [ Time Frame: Dose 4 to 1 month after Dose 4 ]
  • Percentage of participants reporting serious adverse events (SAEs) [ Time Frame: Dose 1 to 6 months after Dose 4 ]
  • Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
  • Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4 [ Time Frame: 1 month after Dose 4 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates

Recruiting

Birmingham, Alabama, United States, 35205

Northwest Arkansas Pediatric Clinic

Recruiting

Fayetteville, Arkansas, United States, 72703

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

Recruiting

Jonesboro, Arkansas, United States, 72401

San Gabriel Woman's Health

Recruiting

Arcadia, California, United States, 91007

Family Medical Clinic

Recruiting

El Monte, California, United States, 91731

Clinical Research of Central California

Recruiting

Fresno, California, United States, 93704

SeraCollection Research Services, LLC

Recruiting

Montebello, California, United States, 90640

Childrens Hospital of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Direct Helpers Research Center

Recruiting

Hialeah, Florida, United States, 33012

C & R Research Services USA

Recruiting

Homestead, Florida, United States, 33030

Florida Pharmaceutical Research and Associates, Inc.

Recruiting

Miami, Florida, United States, 33143

Bioresearch Partner

Recruiting

Miami, Florida, United States, 33155

Gold Coast Health Research Center, LLC

Recruiting

Miami, Florida, United States, 33155

Riveldi and Associates

Recruiting

Miami Lakes, Florida, United States, 33014

Eminent Clinical Research and Associates

Recruiting

North Lauderdale, Florida, United States, 33068

Cordova Research Institute LLC

Recruiting

Sweetwater, Florida, United States, 33182

Altruistic Clinical Research Global

Recruiting

Norcross, Georgia, United States, 30093

Medical Research Partners

Recruiting

Ammon, Idaho, United States, 83406

Bingham Memorial Hospital

Recruiting

Blackfoot, Idaho, United States, 83221

ASR, LLC

Recruiting

Boise, Idaho, United States, 83702

MidValley Research, Inc

Recruiting

Moline, Illinois, United States, 61265

Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)

Recruiting

West Des Moines, Iowa, United States, 50265

Integrity Clinical Network, LLC

Recruiting

Derby, Kansas, United States, 67037

ACC Pediatric Research

Recruiting

Haughton, Louisiana, United States, 71037

Kur Research, LLC

Recruiting

Columbia, Maryland, United States, 21045

Michigan Institute of Research

Recruiting

Allen Park, Michigan, United States, 48101

Michigan Center of Medical Research

Recruiting

Bingham Farms, Michigan, United States, 48025

Vida Clinical Studies, LLC

Recruiting

Dearborn Heights, Michigan, United States, 48127

Velocity Clinical Research, Grand Island

Recruiting

Grand Island, Nebraska, United States, 68803

Midwest Children's Health Research Institute

Recruiting

Lincoln, Nebraska, United States, 68504

Midwest Children's Health Research Institute

Recruiting

Lincoln, Nebraska, United States, 68505

Midwest Children's Health Research Institute

Recruiting

Lincoln, Nebraska, United States, 68516

Midwest Children's Health Research Institute

Recruiting

Lincoln, Nebraska, United States, 68522

Child Health Care Associates

Recruiting

East Syracuse, New York, United States, 13057

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Atrium Health Cannon Research Cente

Recruiting

Charlotte, North Carolina, United States, 28203

Atrium Health - STRIVE Research clinic

Recruiting

Charlotte, North Carolina, United States, 28207

Atrium Health Levine Children's Myers Park Pediatrics

Recruiting

Charlotte, North Carolina, United States, 28207

Duke Vaccine and Trials Unit

Recruiting

Durham, North Carolina, United States, 27703

Durham Pediatrics at North Duke Street

Recruiting

Durham, North Carolina, United States, 27704

Atrium Health Levine Children's Charlotte Pediatrics

Recruiting

Matthews, North Carolina, United States, 28105

Atrium Health STRIVE Research Clinic - Matthews

Recruiting

Matthews, North Carolina, United States, 28105

Pediatric Associates of Mt. Carmel

Recruiting

Cincinnati, Ohio, United States, 45245

PriMED Clinical Research

Recruiting

Dayton, Ohio, United States, 45429

Senders Pediatrics

Recruiting

South Euclid, Ohio, United States, 44121

Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road

Recruiting

Simpsonville, South Carolina, United States, 29680

Proactive RGV

Recruiting

Brownsville, Texas, United States, 78520

Proactive Clinical Research LLC

Recruiting

Edinburg, Texas, United States, 78539

Neutra Life Sciences

Recruiting

Houston, Texas, United States, 77042

Mercury Clinical Research (Administrative Office)

Recruiting

Houston, Texas, United States, 77054

Kool Kids Pediatrics

Recruiting

Houston, Texas, United States, 77065

Mercury Clinical Research - Sunrise Pediatrics

Recruiting

Houston, Texas, United States, 77077

Mercury Clinical Research - Pediatric Associates

Recruiting

Houston, Texas, United States, 77087

Prime Clinical Research - Lewisville

Recruiting

Lewisville, Texas, United States, 75067

Prime Clinical Research - Mansfield

Recruiting

Mansfield, Texas, United States, 76063

SMS Clinical Research LLC

Recruiting

Mesquite, Texas, United States, 75149

Pediatric Center- Neutra Life Sciences

Recruiting

Richmond, Texas, United States, 77469

AMR Clinical

Recruiting

Provo, Utah, United States, 84604

AMR Clinical

Recruiting

Syracuse, Utah, United States, 84075

Clinical Research Partners, LLC

Recruiting

Richmond, Virginia, United States, 23226

Tekton Research, LLC.

Recruiting

Richmond, Virginia, United States, 23233

More Information

Sponsor

Pfizer

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-09.