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Pneumococcal DiseasePhase 3NCT07629440

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

A Phase 3 study testing PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 130 sites in 3 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 infants when compared to the pneumococcal vaccine that… Read more about this study

Who is it for?
Ages 42 to 211 daysHealthy 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
3,230 participants
Where
130 sitesin 3 countries
Study dates
29 May 2026to 5 Jun 2029
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 42 to 211 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

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

130 sites in 3 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

130 sites in 3 countries

United States111 sites, 111 recruiting

  • Michigan Institute of Research

    Allen Park, Michigan, 48101

    Recruiting

  • Medical Research Partners

    Ammon, Idaho, 83406

    Recruiting

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

    Recruiting

  • The Iowa Clinic.

    Ankeny, Iowa, 50023

    Recruiting

  • San Gabriel Woman's Health

    Arcadia, California, 91007

    Recruiting

  • Childrens Hospital of Colorado

    Aurora, Colorado, 80045

    Recruiting

  • University of Maryland, Baltimore, Center for Vaccine Development and Global Health

    Baltimore, Maryland, 21201

    Recruiting

  • UPMC Children's Community Pediatrics- Bellevue

    Bellevue, Pennsylvania, 15202

    Recruiting

  • Coast Clinical Research, LLC

    Bellflower, California, 90706

    Recruiting

  • KUR Research, LLC

    Bessemer, Alabama, 35022

    Not yet recruiting

  • Michigan Center of Medical Research

    Bingham Farms, Michigan, 48025

    Recruiting

  • Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates

    Birmingham, Alabama, 35205

    Recruiting

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama, 35233

    Recruiting

  • Bingham Memorial Hospital

    Blackfoot, Idaho, 83221

    Recruiting

  • ASR, LLC

    Boise, Idaho, 83702

    Recruiting

  • Proactive RGV

    Brownsville, Texas, 78520

    Recruiting

  • ObjectiveHealth Clinical Research LLC - Chamblee

    Chamblee, Georgia, 30341

    Recruiting

  • Atrium Health Cannon Research Cente

    Charlotte, North Carolina, 28203

    Recruiting

  • Atrium Health - STRIVE Research clinic

    Charlotte, North Carolina, 28207

    Recruiting

  • Atrium Health Levine Children's Myers Park Pediatrics

    Charlotte, North Carolina, 28207

    Recruiting

  • Pediatric Associates of Mt. Carmel

    Cincinnati, Ohio, 45245

    Recruiting

  • Kur Research, LLC

    Columbia, Maryland, 21045

    Recruiting

  • The Pediatric Center

    Columbia, Maryland, 21045

    Recruiting

  • University of Missouri Pediatrics Clinic-South Providence

    Columbia, Missouri, 65201

    Recruiting

  • University of Missouri

    Columbia, Missouri, 65212

    Recruiting

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

    Not yet recruiting

  • UPMC Children's Community Pediatrics Bass Wolfson-Cranberry

    Cranberry Township, Pennsylvania, 16066

    Recruiting

  • PriMED Clinical Research

    Dayton, Ohio, 45429

    Recruiting

  • Vida Clinical Studies, LLC

    Dearborn Heights, Michigan, 48127

    Recruiting

  • Integrity Clinical Network, LLC

    Derby, Kansas, 67037

    Recruiting

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703

    Recruiting

  • Durham Pediatrics at North Duke Street

    Durham, North Carolina, 27704

    Recruiting

  • Child Health Care Associates

    East Syracuse, New York, 13057

    Recruiting

  • Proactive Clinical Research LLC

    Edinburg, Texas, 78539

    Recruiting

  • Family Medical Clinic

    El Monte, California, 91731

    Recruiting

  • Proactive El Paso,LLC

    El Paso, Texas, 79902

    Recruiting

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506

    Recruiting

  • Northwest Arkansas Pediatric Clinic

    Fayetteville, Arkansas, 72703

    Recruiting

  • SMS Clinical Research LLC.

    Forney, Texas, 75126

    Recruiting

  • Clinical Research of Central California

    Fresno, California, 93704

    Recruiting

  • University of Texas Medical Branch, Sealy Institute for Vaccine Sciences Clinical Trials Program

    Galveston, Texas, 77555

    Recruiting

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803

    Recruiting

  • ACC Pediatric Research

    Haughton, Louisiana, 71037

    Recruiting

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

    Recruiting

  • Barroso Medical Services LLC

    Hialeah, Florida, 33014

    Not yet recruiting

  • C & R Research Services USA

    Homestead, Florida, 33030

    Recruiting

  • HG Pediatrics/Chemidox TX LLC

    Houston, Texas, 77008

    Recruiting

  • Neutra Life Sciences

    Houston, Texas, 77042

    Recruiting

  • Mercury Clinical Research (Administrative Office)

    Houston, Texas, 77054

    Recruiting

  • Mercury Clinical Research - Administrative Office (Archival Purposes)

    Houston, Texas, 77054

    Recruiting

  • Kool Kids Pediatrics

    Houston, Texas, 77065

    Recruiting

  • Aavon Clinical Trials, LLC.

    Houston, Texas, 77074

    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

  • Houston Clinical Research Associates

    Houston, Texas, 77090

    Recruiting

  • Leavitt Clinical Research

    Idaho Falls, Idaho, 83404

    Recruiting

  • UPMC Children's Community Pediatrics South Hills-Jefferson Hills

    Jefferson Hills, Pennsylvania, 15025

    Recruiting

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

    Jonesboro, Arkansas, 72401

    Recruiting

  • Prime Clinical Research - Lewisville

    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 - Mansfield

    Mansfield, Texas, 76063

    Recruiting

  • Marshfield Medical Center - Marshfield

    Marshfield, Wisconsin, 54449

    Recruiting

  • Atrium Health Levine Children's Charlotte Pediatrics

    Matthews, North Carolina, 28105

    Recruiting

  • Atrium Health STRIVE Research Clinic - Matthews

    Matthews, North Carolina, 28105

    Recruiting

  • Dr. Ruben Aleman & Associates

    McAllen, Texas, 78504

    Recruiting

  • Le Bonheur Children's Hospital - Outpatient Building

    Memphis, Tennessee, 38105

    Recruiting

  • SMS Clinical Research LLC

    Mesquite, Texas, 75149

    Recruiting

  • SMS Clinical Research LLC

    Mesquite, Texas, 75150

    Recruiting

  • Florida Pharmaceutical Research and Associates, Inc.

    Miami, Florida, 33143

    Recruiting

  • International Research II, LLC.

    Miami, Florida, 33144

    Not yet recruiting

  • Bioresearch Partner

    Miami, Florida, 33155

    Recruiting

  • Gold Coast Health Research Center, LLC

    Miami, Florida, 33155

    Recruiting

  • Dade Research Center

    Miami, Florida, 33173

    Recruiting

  • Vasconcello-Cohen MD Research, LLC.

    Miami, Florida, 33183

    Recruiting

  • Riveldi and Associates

    Miami Lakes, Florida, 33014

    Recruiting

  • MidValley Research, Inc

    Moline, Illinois, 61265

    Recruiting

  • SeraCollection Research Services, LLC

    Montebello, California, 90640

    Recruiting

  • Bailony Pediatrics

    National City, California, 91950

    Recruiting

  • Altruistic Clinical Research Global

    Norcross, Georgia, 30093

    Recruiting

  • UPMC Children's Community Pediatrics - Norwin

    North Huntingdon, Pennsylvania, 15642

    Recruiting

  • Eminent Clinical Research and Associates

    North Lauderdale, Florida, 33068

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Not yet recruiting

  • UPMC Children's Hospital of Pittsburgh Primary Care Center-Oakland

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill

    Pittsburgh, Pennsylvania, 15217

    Recruiting

  • UPMC Children's Community Pediatrics-Brentwood

    Pittsburgh, Pennsylvania, 15227

    Recruiting

  • UPMC Children's Community Pediatrics-Castle Shannon

    Pittsburgh, Pennsylvania, 15234

    Recruiting

  • AMR Clinical

    Provo, Utah, 84604

    Recruiting

  • Pediatric Center- Neutra Life Sciences

    Richmond, Texas, 77469

    Recruiting

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

    Recruiting

  • Tekton Research, LLC.

    Richmond, Virginia, 23233

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Recruiting

  • Sun Research Institute

    San Antonio, Texas, 78215

    Recruiting

  • Helios Clinical Research

    Sherwood, Arkansas, 72120

    Recruiting

  • Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road

    Simpsonville, South Carolina, 29680

    Recruiting

  • Senders Pediatrics

    South Euclid, Ohio, 44121

    Recruiting

  • Carolina Family Care

    Summerville, South Carolina, 29486

    Recruiting

  • MUSC Children's Health

    Summerville, South Carolina, 29486

    Recruiting

  • Cordova Research Institute LLC

    Sweetwater, Florida, 33182

    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

  • Crossroads Clinical Research

    Victoria, Texas, 77901

    Recruiting

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

    West Des Moines, Iowa, 50265

    Recruiting

  • Wilmington Health

    Wilmington, North Carolina, 28405

    Recruiting

Other trials in United States

Japan11 sites, 11 recruiting

  • Hosaka Children's Clinic

    Bunkyo, Tokyo, 112-0001

    Recruiting

  • Fukui Aiiku Hospital

    Fukui-shi, Fukui, 910-0833

    Recruiting

  • Fukazawa Pediatric Clinic

    Fukuoka, Fukuoka, 813-0036

    Recruiting

  • Shindo children's clinic

    Fukuoka, Fukuoka, 814-0121

    Recruiting

  • Nintenkaikagoshima Children's Hospital

    Hioki, Kagoshima-ken, 899-2503

    Recruiting

  • Yokoyama Children'S Clinic

    Kasuga, Fukuoka, 816-0801

    Recruiting

  • Kose Children Clinic

    Kofu, Yamanashi, 400-0853

    Recruiting

  • Kubota Children's Clinic

    Osaka, Osaka, 544-0033

    Recruiting

  • Ohigesenseino Kodomo Clinic

    Sapporo, Hokkaido, 062-0907

    Recruiting

  • Futaba Clinic

    Shinjuku-ku, Tokyo, 160-0017

    Recruiting

  • TOYOTA Memorial Hospital

    Toyota-shi, Aichi-ken, 471-8513

    Recruiting

Other trials in Japan

Puerto Rico8 sites, 8 recruiting

  • Clinical Research Investigator Group

    Bayamón, Puerto RICO, 00960

    Recruiting

  • Caguas Clinical Research

    Caguas, Puerto RICO, 00725

    Recruiting

  • San Juan Bautista School of Medicine - Clinical Research Unit

    Caguas, Puerto RICO, 00726

    Recruiting

  • Clinical Research Puerto Rico

    Guayama, Puerto RICO, 00784

    Recruiting

  • Ponce Medical School Foundation Inc./ CAIMED Center

    Ponce, Puerto RICO, 00716

    Recruiting

  • BRCR Global Puerto Rico

    Ponce, Puerto RICO, 00728

    Recruiting

  • BRCR Global Puerto Rico

    San Juan, Puerto RICO, 00907

    Recruiting

  • San Miguel Medical

    Trujillo Alto, Puerto RICO, 00976-3910

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A PHASE 3, 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 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.

Read more

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.

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 NCT07629440
Study groupRoleWhat they receive
Group 1 PG4 (intramuscular)ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)Active comparator20-valent pneumococcal conjugate vaccine (20vPnC)
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
Group 2 PG4 (intramuscular)ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)Active comparator20-valent pneumococcal conjugate vaccine (20vPnC)
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
Group 3 PG4 (intramuscular)ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 3 PG4 (subcutaneous)ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4
Group 3 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 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 events after each dose

    Measured: Day 7

  3. 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

    Measured: Dose 1 to 1 month after Dose 3

  4. 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

    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

  6. 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

    Measured: 1 month after Dose 3

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

    Pneumococcal IgG GMCs 1 month after Dose 4

    Measured: 1 month after Dose 4

Secondary outcomes (17)

  1. Pneumococcal IgG GMCs 1 month after Dose 3

    Pneumococcal IgG GMCs 1 month after Dose 3

    Measured: 1 month after Dose 3

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

    Pneumococcal serotype 3 IgG concentrations 1 month after Dose 3

    Measured: 1 month after Dose 3

  3. Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Measured: 1 month after Dose 4

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

    Differences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3

    Measured: 1 month after Dose 3

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

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

    Measured: 1 month after Dose 4

  6. Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3

    Pneumococcal OPA titers 1 month after Dose 3

    Measured: 1 month after Dose 3

  7. Pneumococcal OPA titers prior to Dose 4

    Pneumococcal OPA titers prior to Dose 4

    Measured: Prior to Dose 4

  8. Pneumococcal OPA titers 1 month after Dose 4

    Pneumococcal OPA titers 1 month after Dose 4

    Measured: 1 month after Dose 4

  9. Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4

    Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4

    Measured: 1 month after Dose 4

  10. Pneumococcal IgG concentrations 1 month after Dose 3

    Pneumococcal IgG concentrations 1 month after Dose 3

    Measured: 1 month after Dose 3

  11. Pneumococcal IgG concentrations prior to Dose 4

    Pneumococcal IgG concentrations prior to Dose 4

    Measured: Prior to Dose 4

  12. Pneumococcal IgG concentrations 1 month after Dose 4

    Pneumococcal IgG concentrations 1 month after Dose 4

    Measured: 1 month after Dose 4

  13. IgG geometric mean fold rise (GMFR) from before Dose 4 to 1 month after Dose 4

    IgG GMFR from before Dose 4 to 1 month after Dose 4

    Measured: Before Dose 4 to 1 month after Dose 4

  14. IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4

    IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4

    Measured: From 1 month after Dose 3 to 1 month after Dose 4

  15. Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3

    Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3

    Measured: 1 month after Dose 3

  16. Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4

    Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4

    Measured: 1 month after Dose 4

  17. Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3

    Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3

    Measured: 1 month after Dose 3

Timeline

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

  1. First posted5 Jun 2026
  2. Study start29 May 2026
  3. Primary completion5 Jun 2029 (estimated)
  4. Study completion5 Jun 2029 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629440
Sponsor's protocol ID
C4931008
Status last verified
Oct 2026
First submitted
27 May 2026
Last updated
20 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 130 sites in 3 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 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: looking for participants now, as of the sponsor's last update on 20 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 130 sites in United States, Japan, 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 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 reporting local reactions within 7 days after each dose (time frame: Day 7). The study lists 7 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 NCT07629440.

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 20 Oct 2026.

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