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Pneumococcal DiseasePhase 3NCT07573462

A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

A Phase 3 study testing PG4 and 20-valent pneumococcal conjugate vaccine (20vPnC) in people with Pneumococcal Disease, run by Pfizer at 78 sites in 10 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 98 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
2,400 participants
Where
78 sitesin 10 countries
Study dates
4 May 2026to 30 Dec 2028
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 98 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants who are about 2 months of age
  • 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

78 sites in 10 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

78 sites in 10 countries

United States25 sites, 25 recruiting

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004

    Recruiting

  • Eagle Clinical Research

    Chicago, Illinois, 60621

    Recruiting

  • Starz Pediatrics

    Estero, Florida, 33928

    Recruiting

  • Pediatric Associates of Fall River

    Fall River, Massachusetts, 02721

    Recruiting

  • Innovate Research Centers, LLC

    Fort Lauderdale, Florida, 33304

    Recruiting

  • MacKoul Pediatrics Fort Myers

    Fort Myers, Florida, 33908

    Recruiting

  • Pediatric Research of Charlottesville, LLC.

    Gordonsville, Virginia, 22942

    Recruiting

  • Cyn3rgy Research Corporation

    Gresham, Oregon, 97030

    Recruiting

  • Boston Children's Health Physicians

    Hawthorne, New York, 10532

    Recruiting

  • Speranza Research Center

    Hialeah, Florida, 33018

    Recruiting

  • Rosemark Women Care Specialists

    Idaho Falls, Idaho, 83404

    Recruiting

  • Lincoln Pediatric Group

    Lincoln, Nebraska, 68516

    Recruiting

  • Dr. Gala, LLC

    Miami, Florida, 33135

    Recruiting

  • Legacy Clinical Trials

    Oklahoma City, Oklahoma, 73103

    Recruiting

  • National Research Centers, Plano LLC

    Plano, Texas, 75093

    Recruiting

  • Donald Guthrie Foundation

    Sayre, Pennsylvania, 18840

    Recruiting

  • Guthrie Medical Group

    Sayre, Pennsylvania, 18840

    Recruiting

  • LSU Health Shreveport Clinical Trials Office

    Shreveport, Louisiana, 71101

    Recruiting

  • Ochsner LSU Health - Progressive Pediatrics

    Shreveport, Louisiana, 71101

    Recruiting

  • Ochsner LSU Health Shreveport Academic Medical Center

    Shreveport, Louisiana, 71103

    Recruiting

  • Ochsner LSU Health Shreveport Ambulatory Care Center

    Shreveport, Louisiana, 71103

    Recruiting

  • Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks

    Simpsonville, South Carolina, 29680

    Recruiting

  • Senders Pediatrics

    South Euclid, Ohio, 44121

    Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

    Recruiting

  • Maria Fareri Children's Hospital

    Valhalla, New York, 10595

    Recruiting

Other trials in United States

Poland11 sites, 11 recruiting

  • IN-VIVO Bydgoszcz

    Bydgoszcz, 85-048

    Recruiting

  • Pratia S.A.

    Bydgoszcz, 85-796

    Recruiting

  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym

    Dziekanów Leśny, 05-092

    Recruiting

  • Przylądek Zdrowia

    Krakow, Lesser Poland Voivodeship, 30-644

    Recruiting

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

    Krakow, 30-348

    Recruiting

  • NZOZ Salmed

    Łęczna, 21-010

    Not yet recruiting

  • ZOZ Medyk

    Milówka, Silesian Voivodeship, 34-360

    Recruiting

  • Healthy Steps Clinic

    Poznan, 60-822

    Recruiting

  • MICS Centrum Medyczne Torun

    Torun, 87-100

    Recruiting

  • Szpital im. Św Jadwigi Śląskiej w Trzebnicy

    Trzebnica, 55-100

    Recruiting

  • Centrum Medyczne AD-MED Sp. z o.o.

    Wroclaw, 50-107

    Recruiting

Other trials in Poland

Finland8 sites, 8 recruiting

  • FVR, Espoon rokotetutkimusklinikka

    Espoo, Uusimaa, 02230

    Recruiting

  • FVR, Etelä-Helsingin rokotetutkimusklinikka

    Helsinki, Uusimaa, 00100

    Recruiting

  • MeVac - Meilahti Vaccine Research Center

    Helsinki, Uusimaa, 00290

    Recruiting

  • FVR, Järvenpään rokotetutkimusklinikka

    Jarvenpaa, Uusimaa, 04400

    Recruiting

  • FVR, Kokkolan rokotetutkimusklinikka

    Kokkola, Keski-Pohjanmaa, 67100

    Recruiting

  • FVR, Oulun rokotetutkimusklinikka

    Oulu, North Ostrobothnia, 90220

    Recruiting

  • FVR, Tampereen rokotetutkimusklinikka

    Tampere, Pirkanmaa, 33100

    Recruiting

  • FVR, Turun rokotetutkimusklinikka

    Turku, Southwest Finland, 20520

    Recruiting

Other trials in Finland

Spain8 sites, 8 recruiting

  • Hospital Antequera

    Antequera, 29200

    Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [barcelona], 08916

    Recruiting

  • Hm Sanchinarro

    Madrid, Madrid, Comunidad de, 28050

    Recruiting

  • HM Montepríncipe

    Madrid, Madrid, Comunidad de, 28660

    Recruiting

  • Hospital Universitario HM Puerta del Sur

    Madrid, Madrid, Comunidad de, 28938

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Instituto Hispalense de Pediatria- IHP1

    Seville, Andalusia, 41014

    Not yet recruiting

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, Madrid, 28850

    Not yet recruiting

Other trials in Spain

Australia7 sites, 7 recruiting

  • Queensland Children's Hospital

    Brisbane, Queensland, 4101

    Recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Recruiting

  • Perth Children's Hospital

    Nedlands, Western Australia, 6009

    Recruiting

  • The Kids Research Institute Australia

    Nedlands, Western Australia, 6009

    Recruiting

  • Murdoch Children's Research Institute

    Parkville, Victoria, 3052

    Recruiting

  • Centre for Children's Health Research

    South Brisbane, Queensland, 4101

    Recruiting

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145

    Recruiting

Other trials in Australia

Germany7 sites, 7 recruiting

  • Praxis J. S. Iffland u. Dr. med. M. Gärtner

    Hamburg, 22415

    Not yet recruiting

  • Dr. med. Karsten Jünger

    Herxheim, Rhineland-Palatinate, 76863

    Recruiting

  • Private office pediatrics

    Hürth, North Rhine-Westphalia, 50354

    Not yet recruiting

  • FMZ Radowsky

    Leipzig, Saxony, 04179

    Recruiting

  • Kinder- und Jugendarztpraxis Dr. med. Michael Horn

    Schönau am Königssee, Bavaria, 83471

    Recruiting

  • Gemeinschaftspraxis für Kinder- und Jugendmedizin

    Tuttlingen, Baden-Wurttemberg, 78532

    Not yet recruiting

  • Kinderärztliche Gemeinschaftspraxis Dr. med. Sören Westerholt Dr. med. Jan Matyas

    Wolfsburg, Lower Saxony, 38448

    Recruiting

Other trials in Germany

Canada4 sites, 4 recruiting

  • Milestone Research Inc.

    London, Ontario, N5W 6A2

    Recruiting

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Not yet recruiting

  • McGill University Health Centre - Vaccine Study Centre

    Pierrefonds-Roxboro, Quebec, H9H4Y6

    Not yet recruiting

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

    Recruiting

Other trials in Canada

Argentina3 sites, 3 recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, X5800AEV

    Not yet recruiting

  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

    San Miguel de Tucumán, Tucumán Province, 4000

    Not yet recruiting

  • Hospital del Niño Jesus

    San Miguel de Tucumán, Tucumán Province, 4000

    Not yet recruiting

Other trials in Argentina

Italy3 sites, 3 recruiting

  • AOU Policlinico di Bari

    Bari, 70124

    Recruiting

  • Policlinico Foggia Hospital

    Foggia, 71122

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano

    Milan, Milan, 20122

    Recruiting

Other trials in Italy

Hungary2 sites, 2 recruiting

  • Elitance Duo Kft.

    Budapest, 1188

    Not yet recruiting

  • BEBI-MED Egeszsegugyi Szolgaltato Kft.

    Miskolc, 3529

    Not yet recruiting

Other trials in Hungary

About this study

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY 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. 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.

Read more

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

  • infants who are about 2 months of age

About 2400 infants will be assigned by chance to one of the two groups to receive 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.

Infants will take part in this study for about 16 to 19 months (about 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.

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 NCT07573462
Study groupRoleWhat they receive
20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)Active comparator20-valent pneumococcal conjugate vaccine (20vPnC)
Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
PG4 (intramuscular)ExperimentalMultivalent Pneumococcal Vaccine
Receives: Biological: PG4

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

Timeline

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

  1. First posted7 May 2026
  2. Study start4 May 2026
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2028 (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
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573462
Sponsor's protocol ID
C4931007
Other IDs
2025-523447-35-00, 2025
Status last verified
Oct 2026
First submitted
30 Apr 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 78 sites in 10 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: 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 78 sites in United States, Poland, Finland, Spain, Australia and 5 more countries. 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 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?

On the ClinicalTrials.gov record for NCT07573462.

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.

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