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Pneumococcal DiseasePhase 3NCT07660198

Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

A Phase 3 study testing PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 77 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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 that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that… Read more about this study

Who is it for?
Ages 15 months to 17 yearsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Disease
What is being tested?
PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
77 sitesin 4 countries
Study dates
15 Jun 2026to 2 Dec 2027
Phase
Phase 3
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 15 months to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.
  • Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.
  • Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.

Who cannot join

  • All Cohorts (Participants ≥15 Months to <18 Years of Age)
  • Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial

Trial locations and contacts

77 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

77 sites in 4 countries

United States62 sites, 62 recruiting

  • Medical Research Partners

    Ammon, Idaho, 83406

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004

    Recruiting

  • Michigan Center of Medical Research

    Bingham Farms, Michigan, 48025

    Recruiting

  • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates

    Birmingham, Alabama, 35205

    Recruiting

  • UAB Child Health Research Unit (CHRU)

    Birmingham, Alabama, 35233

    Recruiting

  • Bingham Memorial Hospital

    Blackfoot, Idaho, 83221

    Recruiting

  • ASR, LLC

    Boise, Idaho, 83702

    Recruiting

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902

    Recruiting

  • Cincinnati Children's Hospital Medical Center Investigational Drug Services

    Cincinnati, Ohio, 45206

    Recruiting

  • Cincinnati Children's Hospital Medical Center Vaccine Research Center

    Cincinnati, Ohio, 45206

    Recruiting

  • Pediatric Associates of Mt. Carmel

    Cincinnati, Ohio, 45245

    Recruiting

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

    Recruiting

  • Driscoll Children's Hosptial

    Corpus Christi, Texas, 78411

    Recruiting

  • Avacare

    Covington, Louisiana, 70433

    Recruiting

  • Dayton Clinical Research

    Dayton, Ohio, 45409

    Recruiting

  • Child Health Care Associates

    East Syracuse, New York, 13057

    Recruiting

  • Apex Research Group

    Fair Oaks, California, 95628

    Recruiting

  • Pediatric Associates of Fall River

    Fall River, Massachusetts, 02721

    Recruiting

  • Lakeview Clinical Research, LLC

    Guntersville, Alabama, 35976

    Recruiting

  • Corning Center for Clinical Research

    Horseheads, New York, 14845

    Recruiting

  • HG Pediatrics/Chemidox TX LLC

    Houston, Texas, 77008

    Recruiting

  • Mercury Clinical Research (Administrative Office)

    Houston, Texas, 77054

    Recruiting

  • Mercury Clinical Research - Administrative Office

    Houston, Texas, 77054

    Recruiting

  • Kool Kids Pediatrics

    Houston, Texas, 77065

    Recruiting

  • RTX Clinical Research

    Houston, Texas, 77074

    Recruiting

  • Mercury Clinical Research - Sunrise Pediatrics

    Houston, Texas, 77077

    Recruiting

  • Mercury Clinical Research - MD Kids Pediatrics

    Houston, Texas, 77087

    Recruiting

  • Neutra Life Sciences

    Houston, Texas, 77402

    Recruiting

  • Velocity Clinical Research, Lafayette

    Lafayette, Louisiana, 70508

    Recruiting

  • Tanner Clinic - Layton Parkway

    Layton, Utah, 84041

    Recruiting

  • Tanner Clinic

    Layton, Utah, 84041

    Recruiting

  • University of Texas Medical Branch,

    League City, Texas, 77573

    Recruiting

  • Prime Clinical Research Inc.

    Lewisville, Texas, 75067

    Recruiting

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68504

    Recruiting

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68505

    Recruiting

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68516

    Recruiting

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68522

    Recruiting

  • Prime Clinical Research Inc.

    Mansfield, Texas, 76063

    Recruiting

  • Riveldi and Associates

    Miami Lakes, Florida, 33014

    Recruiting

  • Indago Research & Health Center, Inc

    Miami Lakes, Florida, 33016

    Recruiting

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

    Recruiting

  • Orange County Research Institute

    Ontario, California, 91762

    Recruiting

  • AMR Clinical

    Provo, Utah, 84604

    Recruiting

  • Pediatric Center- Neutra Life Sciences

    Richmond, Texas, 77469

    Recruiting

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Recruiting

  • Sun Research Institute

    San Antonio, Texas, 78215

    Recruiting

  • LSU Health Shreveport Clinical Trials Office

    Shreveport, Louisiana, 71101

    Recruiting

  • Ochsner/LSU Health Shreveport - Progressive Pediatrics

    Shreveport, Louisiana, 71101

    Recruiting

  • Ochsner LSU Health Shreveport Ambulatory Care Center

    Shreveport, Louisiana, 71103

    Recruiting

  • Ochsner/LSU Health Shreveport Academic Medical Center

    Shreveport, Louisiana, 71103

    Recruiting

  • Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks

    Simpsonville, South Carolina, 29681

    Recruiting

  • Senders Pediatrics

    South Euclid, Ohio, 44121

    Recruiting

  • AMR Clinical

    Syracuse, Utah, 84075

    Recruiting

  • South Tampa Center for Advanced Healthcare- USF Health

    Tampa, Florida, 33606

    Recruiting

  • USF Health

    Tampa, Florida, 33606

    Recruiting

  • USF Health Department of Pediatrics The Chalsty Clinics at the Curran Children's Health Center (CMS)

    Tampa, Florida, 33612

    Recruiting

  • Children's Health Center

    Tampa, Florida, 33617

    Recruiting

  • Pediatric Clinical Trials of Tennessee, LLC

    Tullahoma, Tennessee, 37388

    Recruiting

  • Victoria Clinical Research Group

    Victoria, Texas, 77901

    Recruiting

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

    Recruiting

Other trials in United States

Poland6 sites, 6 recruiting

  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym

    Dziekanów Leśny, 05-092

    Not yet recruiting

  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

    Krakow, 30-348

    Not yet recruiting

  • Przylądek Zdrowia

    Krakow, 30-644

    Not yet recruiting

  • ZOZ Medyk

    Milówka, Silesian Voivodeship, 34-360

    Not yet recruiting

  • ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o.

    Tarnów, 33-100

    Not yet recruiting

  • Szpital im. Św Jadwigi Śląskiej w Trzebnicy

    Trzebnica, 55-100

    Not yet recruiting

Other trials in Poland

Puerto Rico6 sites, 6 recruiting

  • Caguas Clinical Research LLC

    Caguas, 00725

    Recruiting

  • Ponce Medical School Foundation Inc. / CAIMED Center

    Ponce, 00716

    Recruiting

  • BRCR Global Puerto Rico

    Ponce, 00728

    Recruiting

  • BRCR Global Puerto Rico

    San Juan, 00907-1509

    Recruiting

  • CMRC Headlands, LLC

    San Juan, 00918

    Recruiting

  • San Miguel Medical

    Trujillo Alto, 00976-3910

    Recruiting

Other trials in Puerto Rico

Finland3 sites, 3 recruiting

  • MeVac - Meilahti Vaccine Research Center

    Helsinki, Uusimaa, 00290

    Not yet recruiting

  • FVR, Tampereen rokotetutkimusklinikka

    Tampere, Pirkanmaa, 33100

    Not yet recruiting

  • FVR, Turun rokotetutkimusklinikka

    Turku, Southwest Finland, 20520

    Not yet recruiting

Other trials in Finland

About this study

Official title: A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS

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 children 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. 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 children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae

Read more

This study is seeking participants who:

  • Are children aged 15 months to 18 years.
  • May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.

The study will be conducted in the United States, Puerto Rico, and other countries.

Participants will be assigned to 1 of 3 groups based on age:

Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)

Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.

Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).

At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.

Being tested
PG4, 20-valent pneumococcal conjugate vaccine (20vPnC)
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 Vaccine

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

    Also called Prevnar 20

    20-valent pneumococcal conjugate vaccine (20vPnC)

Study groups in NCT07660198
Study groupRoleWhat they receive
PG4 (intramuscular)ExperimentalMultivalent Pneumococcal vaccine
Receives: Biological: PG4
20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)Active comparator20-valent pneumococcal conjugate vaccine (20vPnC)
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

What is being measured

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

  1. Percentage of Participants With Local Reactions Within 7 Days After Vaccination

    Measured: Within 7 days after Vaccination

  2. Percentage of Participants With Systemic Events Within 7 Days after Vaccination

    Measured: Within 7 days after Vaccination

  3. Percentage of Participants With Adverse Events (AEs)

    Measured: From Vaccination to 1 month after Vaccination

  4. Percentage of Participants With Serious Adverse Events (SAEs)

    Measured: From Vaccination to 6 months after Vaccination

  5. GMCs of serotype-specific IgG concentrations

    Measured: 1 month after vaccination

  6. GMTs of serotype-specific OPA titers

    Measured: 1 month after vaccination

Secondary outcomes (4)

  1. Percentage of participants with predefined serotype-specific IgG concentrations

    Measured: 1 month after vaccination

  2. IgG GMFRs

    Measured: 1 month after vaccination

  3. Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers

    Measured: before to 1 month after vaccination

  4. OPA GMFRs

    Measured: before to 1 month after vaccination

Timeline

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

  1. First posted22 Jun 2026
  2. Study start15 Jun 2026
  3. Primary completion2 Dec 2027 (estimated)
  4. Study completion2 Dec 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07660198
Sponsor's protocol ID
C4931004
Other IDs
2025-523445-10-00, 2025
Status last verified
Oct 2026
First submitted
15 Jun 2026
Last updated
26 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 3 study testing PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 77 sites in 4 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 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 77 sites in United States, Poland, Puerto Rico, Finland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Local Reactions Within 7 Days After Vaccination (time frame: Within 7 days after Vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07660198.

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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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