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

NCT07629440 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: C4931008
• Study Type: interventional
• Target: 3,230
• Locations: 3 countries
• Sites: 73

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

Outcome Measures

Primary Outcomes (7)

• Percentage of participants reporting local reactions within 7 days after each dose

  Prompted local reactions after each dose

  Day 7

• Percentage of participants reporting systemic events within 7 days after each dose

  Prompted systemic events after each dose

  Day 7

• Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3

  AEs occurring from Dose 1 to 1 month after Dose 3

  Dose 1 to 1 month after Dose 3

• Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4

  AEs occurring from Dose 4 to 1 month after Dose 4

  Dose 4 to 1 month after Dose 4

• Percentage of participants reporting serious adverse events (SAEs)

  SAEs occurring from Dose 1 to 6 months after Dose 4

  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

  Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3

  1 month after Dose 3

• Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4

  Pneumococcal IgG GMCs 1 month after Dose 4

  1 month after Dose 4

Secondary Outcomes (17)

• Pneumococcal IgG GMCs 1 month after Dose 3

  1 month after Dose 3

• Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3

  1 month after Dose 3

• Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

  1 month after Dose 4

• Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3

  1 month after Dose 3

• Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4

  1 month after Dose 4

Study Arms (7)

Group 1 PG4 (intramuscular)

EXPERIMENTAL

Multivalent Pneumococcal Vaccine

Biological: PG4

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

ACTIVE COMPARATOR

20-valent pneumococcal conjugate vaccine (20vPnC)

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

Group 2 PG4 (intramuscular)

EXPERIMENTAL

Multivalent Pneumococcal Vaccine

Biological: PG4

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

ACTIVE COMPARATOR

20-valent pneumococcal conjugate vaccine (20vPnC)

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

Group 3 PG4 (intramuscular)

EXPERIMENTAL

Multivalent Pneumococcal Vaccine

Biological: PG4

Group 3 PG4 (subcutaneous)

EXPERIMENTAL

Multivalent Pneumococcal Vaccine

Biological: PG4

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

ACTIVE COMPARATOR

20-valent pneumococcal conjugate vaccine (20vPnC)

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

Interventions

PG4 BIOLOGICAL

Multivalent Pneumococcal Vaccine

Group 1 PG4 (intramuscular); Group 2 PG4 (intramuscular); Group 3 PG4 (intramuscular); Group 3 PG4 (subcutaneous)

20-valent pneumococcal conjugate vaccine (20vPnC) BIOLOGICAL

20-valent pneumococcal conjugate vaccine (20vPnC)

Also known as: Prevnar 20

Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular); Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular); Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)

Eligibility Criteria

• Age: 42 Days - 211 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (73)

Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates

Birmingham, Alabama, 35205, United States

RECRUITING

Northwest Arkansas Pediatric Clinic

Fayetteville, Arkansas, 72703, United States

NOT YET RECRUITING

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

Jonesboro, Arkansas, 72401, United States

NOT YET RECRUITING

San Gabriel Woman's Health

Arcadia, California, 91007, United States

NOT YET RECRUITING

Family Medical Clinic

El Monte, California, 91731, United States

NOT YET RECRUITING

Clinical Research of Central California

Fresno, California, 93704, United States

RECRUITING

SeraCollection Research Services, LLC

Montebello, California, 90640, United States

NOT YET RECRUITING

Stanford University Medical Center CTRU - 800 Welch Road

Palo Alto, California, 94304, United States

NOT YET RECRUITING

C & R Research Services USA

Homestead, Florida, 33030, United States

RECRUITING

Florida Pharmaceutical Research and Associates, Inc.

Miami, Florida, 33143, United States

RECRUITING

Bioresearch Partner

Miami, Florida, 33155, United States

NOT YET RECRUITING

Gold Coast Health Research Center, LLC

Miami, Florida, 33155, United States

NOT YET RECRUITING

Dade Research Center

Miami, Florida, 33173, United States

NOT YET RECRUITING

Vasconcello-Cohen MD Research, LLC.

Miami, Florida, 33183, United States

NOT YET RECRUITING

Riveldi and Associates

Miami Lakes, Florida, 33014, United States

NOT YET RECRUITING

Eminent Clinical Research and Associates

North Lauderdale, Florida, 33068, United States

RECRUITING

Cordova Research Institute LLC

Sweetwater, Florida, 33182, United States

NOT YET RECRUITING

Altruistic Clinical Research Global

Norcross, Georgia, 30093, United States

RECRUITING

Medical Research Partners

Ammon, Idaho, 83406, United States

NOT YET RECRUITING

ASR, LLC

Boise, Idaho, 83702, United States

NOT YET RECRUITING

MidValley Research, Inc

Moline, Illinois, 61265, United States

NOT YET RECRUITING

The Iowa Clinic.

Ankeny, Iowa, 50023, United States

NOT YET RECRUITING

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

West Des Moines, Iowa, 50265, United States

NOT YET RECRUITING

Integrity Clinical Network, LLC

Derby, Kansas, 67037, United States

NOT YET RECRUITING

ACC Pediatric Research

Haughton, Louisiana, 71037, United States

RECRUITING

Kur Research, LLC

Columbia, Maryland, 21045, United States

NOT YET RECRUITING

Michigan Institute of Research

Allen Park, Michigan, 48101, United States

NOT YET RECRUITING

Michigan Center of Medical Research

Bingham Farms, Michigan, 48025, United States

NOT YET RECRUITING

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, 68803, United States

NOT YET RECRUITING

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68504, United States

NOT YET RECRUITING

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68505, United States

NOT YET RECRUITING

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68516, United States

RECRUITING

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68522, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

NOT YET RECRUITING

Duke Vaccine and Trials Unit

Durham, North Carolina, 27703, United States

RECRUITING

Durham Pediatrics at North Duke Street

Durham, North Carolina, 27704, United States

RECRUITING

Wilmington Health

Wilmington, North Carolina, 28405, United States

NOT YET RECRUITING

Pediatric Associates of Mt. Carmel

Cincinnati, Ohio, 45245, United States

NOT YET RECRUITING

PriMED Clinical Research

Dayton, Ohio, 45429, United States

NOT YET RECRUITING

Senders Pediatrics

South Euclid, Ohio, 44121, United States

RECRUITING

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States

NOT YET RECRUITING

Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road

Simpsonville, South Carolina, 29680, United States

RECRUITING

Pediatric Clinical Trials of Tennessee, LLC

Tullahoma, Tennessee, 37388, United States

NOT YET RECRUITING

Proactive RGV

Brownsville, Texas, 78520, United States

NOT YET RECRUITING

Proactive Clinical Research LLC

Edinburg, Texas, 78539, United States

NOT YET RECRUITING

Proactive El Paso,LLC

El Paso, Texas, 79902, United States

NOT YET RECRUITING

Neutra Life Sciences

Houston, Texas, 77042, United States

NOT YET RECRUITING

Mercury Clinical Research (Administrative Office)

Houston, Texas, 77054, United States

RECRUITING

Kool Kids Pediatrics

Houston, Texas, 77065, United States

NOT YET RECRUITING

Mercury Clinical Research - Sunrise Pediatrics

Houston, Texas, 77077, United States

RECRUITING

Mercury Clinical Research - Pediatric Associates

Houston, Texas, 77087, United States

RECRUITING

Houston Clinical Research Associates

Houston, Texas, 77090, United States

NOT YET RECRUITING

SMS Clinical Research LLC

Mesquite, Texas, 75149, United States

RECRUITING

Pediatric Center- Neutra Life Sciences

Richmond, Texas, 77469, United States

NOT YET RECRUITING

AMR Clinical

Provo, Utah, 84604, United States

NOT YET RECRUITING

AMR Clinical

Syracuse, Utah, 84075, United States

NOT YET RECRUITING

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

RECRUITING

Tekton Research, LLC.

Richmond, Virginia, 23233, United States

NOT YET RECRUITING

Shindo children's clinic

Fukuoka, Fukuoka, 814-0121, Japan

NOT YET RECRUITING

Yokoyama Children'S Clinic

Kasuga, Fukuoka, 816-0801, Japan

NOT YET RECRUITING

Ohigesenseino Kodomo Clinic

Sapporo, Hokkaido, 062-0907, Japan

NOT YET RECRUITING

Futaba Clinic

Shinjuku-ku, Tokyo, 160-0017, Japan

NOT YET RECRUITING

Kose Children Clinic

Kofu, Yamanashi, 400-0853, Japan

NOT YET RECRUITING

Fukui Aiiku Hospital

Fukui, 910-0833, Japan

NOT YET RECRUITING

Kubota Children's Clinic

Osaka, 544-0033, Japan

NOT YET RECRUITING

Clinical Research Investigator Group

Bayamón, 00960, Puerto Rico

NOT YET RECRUITING

Caguas Clinical Research

Caguas, 00725, Puerto Rico

NOT YET RECRUITING

San Juan Bautista School of Medicine - Clinical Research Unit

Caguas, 00726, Puerto Rico

NOT YET RECRUITING

Clinical Research Puerto Rico

Guayama, 00784, Puerto Rico

NOT YET RECRUITING

Ponce Medical School Foundation Inc./ CAIMED Center

Ponce, 00716, Puerto Rico

NOT YET RECRUITING

BRCR Global Puerto Rico

Ponce, 00717, Puerto Rico

NOT YET RECRUITING

BRCR Global Puerto Rico

San Juan, 00907, Puerto Rico

NOT YET RECRUITING

San Miguel Medical

Trujillo Alto, 00976-3910, Puerto Rico

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 5, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): June 5, 2029
• Study Completion (Estimated): June 5, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

PR (8); JP (7); US (58)