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Pneumococcal DiseasePhase 2NCT06524414

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

A Phase 2 study testing PG4, 20-valent pneumococcal conjugate vaccine (20vPnC) and 15-valent pneumococcal conjugate vaccine (PCV15) in people with Pneumococcal Disease, run by Pfizer at 67 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine. Read more about this study

Who is it for?
Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for
Pneumococcal Disease
What is being tested?
PG4, 20-valent pneumococcal conjugate vaccine (20vPnC) and 15-valent pneumococcal conjugate vaccine (PCV15)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
67 sitesin 2 countries
Study dates
25 Jul 2024to 1 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 42 to 98 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Who cannot join

  • 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.

Trial locations and contacts

67 sites in 2 countries.

67 sites in 2 countries

United States60 sites
  • The Iowa Clinic

    Ankeny, Iowa, 50023

  • University of Maryland

    Baltimore, Maryland, 21201

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902

  • Javara Inc.

    Dallas, Texas, 75230

  • Oak Cliff Research Company, LLC

    Dallas, Texas, 75287

  • Dayton Clinical Research

    Dayton, Ohio, 45409

  • Ohio Pediatric Research Assn.

    Dayton, Ohio, 45414

  • Velocity Clinical Research Inc.

    Durham, North Carolina, 27701

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703

  • Durham Pediatrics at North Duke Street

    Durham, North Carolina, 27704

  • Child Health Care Associates

    East Syracuse, New York, 13057

  • PAS Research - McAllen

    Edinburg, Texas, 78539

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506

  • Square-1 Clincal Research

    Erie, Pennsylvania, 16506

  • Pediatric Associates of Fall River

    Fall River, Massachusetts, 02721

  • Northwest Arkansas Pediatric Clinic

    Fayetteville, Arkansas, 72703

  • UMB/CVD

    Frederick, Maryland, 21702

  • Boeson Research GTF

    Great Falls, Montana, 59405

  • OBGYN Associates

    Great Falls, Montana, 59405

  • Origin Health

    Great Falls, Montana, 59405

  • Cyn3rgy Research

    Gresham, Oregon, 97030

  • Mercury clinical research Inc.

    Houston, Texas, 77054

  • Mercury Clinical Research - Pediatric Associates

    Houston, Texas, 77087

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • The Children's Clinic

    Jonesboro, Arkansas, 72401

  • Boeson Research KAL

    Kalispell, Montana, 59901

  • Heart and Hands Midwifery and Family Practice

    Kalispell, Montana, 59901

  • POEM Healthcare

    Kalispell, Montana, 59901

  • AMR Clinical

    Kaysville, Utah, 84037

  • Tanner Clinic - Kaysville

    Kaysville, Utah, 84037

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Los Ninos Children's Medical Clinic

    La Puente, California, 91744

  • Alliance for Multispecialty Research, LLC

    Layton, Utah, 84041

  • Tanner Clinic

    Layton, Utah, 84041

  • Tanner Memorial Clinic

    Layton, Utah, 84041

  • University of Texas Medical Branch

    League City, Texas, 77573

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68522

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • All Children Pediatrics

    Louisville, Kentucky, 40243

  • Bluegrass Clinical Research, Inc.

    Louisville, Kentucky, 40291

  • Riveldi Biomedical Research and Associates - Miami

    Miami Lakes, Florida, 33014

  • Blue Moose Pediatrics

    Missoula, Montana, 59804

  • Boeson Research Laboratory

    Missoula, Montana, 59804

  • Boeson Research MSO

    Missoula, Montana, 59804

  • AMR Clinical

    Murray, Utah, 84107

  • AMR Clinical

    Provo, Utah, 84604

  • University of Rochester

    Rochester, New York, 14611

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • AMR Clinical

    Roy, Utah, 84067

  • LSUHSC Clinical Trials Office

    Shreveport, Louisiana, 71101

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana, 71103

  • Ochsner/LSU Health Ambulatory Care Center

    Shreveport, Louisiana, 71103

  • Senders Pediatrics

    South Euclid, Ohio, 44121

  • AMR Clinical

    South Jordan, Utah, 84095

  • Coastal Pediatric Research

    Summerville, South Carolina, 29486

  • AMR Clinical

    Syracuse, Utah, 84075

  • Cotton O'Neil Pediatrics

    Topeka, Kansas, 66604

  • Velocity Clinical Research, Washington DC

    Washington D.C., District of Columbia, 20016

  • Los Ninos Children's Medical Clinic

    West Covina, California, 91790

Other trials in United States

Puerto Rico7 sites
  • Clinical Research Puerto Rico

    Guayama, 00784

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

  • BRCR Global Puerto Rico

    San Juan, 00907-1509

  • CMRC Headlands, LLC

    San Juan, 00918

  • University of Puerto Rico - Medical Sciences Campus

    San Juan, 00935-6528

  • The Hispanic Alliance for Clinical and Translational Research

    San Juan, 00935

  • San Miguel Medical

    Trujillo Alto, PR, 00976

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

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 in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine.

To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution.

Read more

The immune response is how the body's cells; tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.

This study is seeking participants who are:

  • male or female infants who are 2 months of age,
  • infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and,
  • said to be healthy by the study doctor

There are four groups in this study. All participants will be assigned to one of the four groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study.

The first 400 participants who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1.

Once 400 participants have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3. Half the participants in Group 3 will receive PG4 in the second solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Groups 3 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age.

Once the 100 participants have been assigned to Group 3 then 300 new participants will be assigned to Group 4. Half the participants in Group 4 will receive PG4 in the first solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Group 4 will receive 4 doses of a licensed pneumococcal comparator vaccine at 2, 4, 6, and 12 to 15 months of age.

Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.

Being tested
PG4, 20-valent pneumococcal conjugate vaccine (20vPnC), 15-valent pneumococcal conjugate vaccine (PCV15)
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PG4Biological

    Multivalent pneumococcal conjugate vaccine

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

    Also called Prevnar 20

    20-valent pneumococcal conjugate vaccine

  • 15-valent pneumococcal conjugate vaccine (PCV15)Biological

    Also called PCV15

    15-valent pneumococcal conjugate vaccine

Study groups in NCT06524414
Study groupRoleWhat they receive
Group 1 PG4ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)Active comparator20-valent pneumococcal conjugate vaccine (20vPnC)
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
Group 2 PG4ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)Active comparator20-valent pneumococcal conjugate vaccine (20vPnC)
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
Group 3 PG4ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 3 20-valent pneumococcal conjugate vaccine (20vPnC)Active comparator20-valent pneumococcal conjugate vaccine (20vPnC)
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
Group 4 PG4ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 4 15-valent pneumococcal conjugate vaccine (PCV15)Active comparator15-valent pneumococcal conjugate vaccine (PCV15)
Receives: Biological: 15-valent pneumococcal conjugate vaccine (PCV15)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Prompted local reactions after each dose

    Measured: Day 7

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

    Prompted systemic reactions after each dose

    Measured: Day 7

  3. Percentage of participants reporting adverse events (AEs)

    AEs occurring from Dose 1 to 1 month after Dose 2

    Measured: Dose 1 to 1 month after Dose 3

  4. Percentage of participants reporting AEs

    AEs occurring from Dose 4 to 1 month after Dose 4

    Measured: Dose 4 to 1 month after Dose 4

  5. Percentage of participants reporting serious adverse events (SAEs)

    SAEs occurring from Dose 1 to 6 months after Dose 4

    Measured: Dose 1 to 6 months after Dose 4

Secondary outcomes (1)
  1. Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)

    Pneumococcal IgG GMCs 1 month after Dose 4

    Measured: 1 month after Dose 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start25 Jul 2024
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524414
Sponsor's protocol ID
C4931002
Other IDs
NCT06524414, 2025-000081-28, 2025
Status last verified
Oct 2026
First submitted
23 Jul 2024
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PG4, 20-valent pneumococcal conjugate vaccine (20vPnC) and 15-valent pneumococcal conjugate vaccine (PCV15) in people with Pneumococcal Disease, run by Pfizer at 67 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants reporting local reactions within 7 days after each dose (time frame: Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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