NCT07629440ClinicalTrials.gov

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

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

RecruitingTaking participants now, according to the registry record.

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In brief

Phase 33,230 participants sought124 sites3 countries

Registered in 1 registry

ClinicalTrials.govNCT07629440Open this record at ClinicalTrials.govSynced 2 weeks ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 7 days after the recorded start)First posted 2026-06-05; recorded start 2026-05-29
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 606 other studies in this databaseCounted from the lead sponsor named in the record (Pfizer)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 97 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 3,230 participants (target), run at 124 sites, across 3 countries.

How this score is built

Enrolment34/40
3,230 participants (target)
Site count22/25
97 sites
Country count7/15
3 countries
Planned duration8/10
Planned over about 37 months
Sponsor scale10/10
Pfizer has led 584 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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

Eligibility

Eligibility
Sex	All
Ages	42 Days – 211 Days
Healthy volunteers	Yes

Eligibility as written in the registry

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	PREVENTION
Masking	QUADRUPLE (4)
Enrolment	3,230 participants sought

Sponsor and collaborators

Pfizer Sponsor

Arms and interventions

Group 1 PG4 (intramuscular)EXPERIMENTAL
Multivalent Pneumococcal Vaccine
Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR
20-valent pneumococcal conjugate vaccine (20vPnC)
Group 2 PG4 (intramuscular)EXPERIMENTAL
Multivalent Pneumococcal Vaccine
Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR
20-valent pneumococcal conjugate vaccine (20vPnC)
Group 3 PG4 (intramuscular)EXPERIMENTAL
Multivalent Pneumococcal Vaccine
Group 3 PG4 (subcutaneous)EXPERIMENTAL
Multivalent Pneumococcal Vaccine
Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR
20-valent pneumococcal conjugate vaccine (20vPnC)

Interventions

Biological 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Biological PG4
Multivalent Pneumococcal Vaccine

Outcome measures

Primary outcome
Percentage of participants reporting local reactions within 7 days after each dose
Prompted local reactions after each dose
Time frame Day 7
Primary outcome
Percentage of participants reporting systemic events within 7 days after each dose
Prompted systemic events after each dose
Time frame Day 7
Primary outcome
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
Time frame Dose 1 to 1 month after Dose 3
Primary outcome
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
Time frame Dose 4 to 1 month after Dose 4
Primary outcome
Percentage of participants reporting serious adverse events (SAEs)
SAEs occurring from Dose 1 to 6 months after Dose 4
Time frame Dose 1 to 6 months after Dose 4
Primary outcome
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
Time frame 1 month after Dose 3
Primary outcome
Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4
Pneumococcal IgG GMCs 1 month after Dose 4
Time frame 1 month after Dose 4
Secondary outcome
Pneumococcal IgG GMCs 1 month after Dose 3
Pneumococcal IgG GMCs 1 month after Dose 3
Time frame 1 month after Dose 3
Secondary outcome
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
Time frame 1 month after Dose 3
Secondary outcome
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
Time frame 1 month after Dose 4
Secondary outcome
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
Time frame 1 month after Dose 3
Secondary outcome
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
Time frame 1 month after Dose 4
Secondary outcome
Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3
Pneumococcal OPA titers 1 month after Dose 3
Time frame 1 month after Dose 3
Secondary outcome
Pneumococcal OPA titers prior to Dose 4
Pneumococcal OPA titers prior to Dose 4
Time frame Prior to Dose 4
Secondary outcome
Pneumococcal OPA titers 1 month after Dose 4
Pneumococcal OPA titers 1 month after Dose 4
Time frame 1 month after Dose 4
Secondary outcome
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
Time frame 1 month after Dose 4
Secondary outcome
Pneumococcal IgG concentrations 1 month after Dose 3
Pneumococcal IgG concentrations 1 month after Dose 3
Time frame 1 month after Dose 3
Secondary outcome
Pneumococcal IgG concentrations prior to Dose 4
Pneumococcal IgG concentrations prior to Dose 4
Time frame Prior to Dose 4
Secondary outcome
Pneumococcal IgG concentrations 1 month after Dose 4
Pneumococcal IgG concentrations 1 month after Dose 4
Time frame 1 month after Dose 4
Secondary outcome
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
Time frame Before Dose 4 to 1 month after Dose 4
Secondary outcome
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
Time frame From 1 month after Dose 3 to 1 month after Dose 4
Secondary outcome
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
Time frame 1 month after Dose 3
Secondary outcome
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
Time frame 1 month after Dose 4
Secondary outcome
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
Time frame 1 month after Dose 3

Dates

Dates
Start date	May 29, 2026 (actual)
Primary completion	June 5, 2029 (estimated)
Completion	June 5, 2029 (estimated)
First posted	June 5, 2026 (actual)
Last updated	September 8, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

114 sites are recruiting

Japan

Japan
Facility	City	State or region	Status
Fukui Aiiku Hospital	Fukui		Recruiting
Shindo children's clinic	Fukuoka	Fukuoka	Recruiting
Fukazawa Pediatric Clinic	Fukuoka		Recruiting
Nintenkaikagoshima Children's Hospital	Hioki	Kagoshima-ken	Recruiting
Yokoyama Children'S Clinic	Kasuga	Fukuoka	Recruiting
Kose Children Clinic	Kofu	Yamanashi	Recruiting
Kubota Children's Clinic	Osaka		Recruiting
Ohigesenseino Kodomo Clinic	Sapporo	Hokkaido	Recruiting
Futaba Clinic	Shinjuku-ku	Tokyo	Recruiting
TOYOTA Memorial Hospital	Toyota-shi	Aichi-ken	Recruiting

Puerto Rico

Puerto Rico
Facility	City	Status
Clinical Research Investigator Group	Bayamón	Recruiting
San Juan Bautista School of Medicine - Clinical Research Unit	Caguas	Recruiting
Caguas Clinical Research	Caguas	Recruiting
Clinical Research Puerto Rico	Guayama	Recruiting
BRCR Global Puerto Rico	Ponce	Recruiting
Ponce Medical School Foundation Inc./ CAIMED Center	Ponce	Recruiting
BRCR Global Puerto Rico	San Juan	Recruiting
San Miguel Medical	Trujillo Alto	Recruiting

United States

United States
Facility	City	State or region	Status
Michigan Institute of Research	Allen Park	Michigan	Recruiting
Medical Research Partners	Ammon	Idaho	Recruiting
Advanced Research Center, Inc.	Anaheim	California	Recruiting
The Iowa Clinic.	Ankeny	Iowa	Recruiting
San Gabriel Woman's Health	Arcadia	California	Recruiting
Childrens Hospital of Colorado	Aurora	Colorado	Recruiting
University of Maryland, Baltimore, Center for Vaccine Development and Global Health	Baltimore	Maryland	Not yet recruiting
UPMC Children's Community Pediatrics- Bellevue	Bellevue	Pennsylvania	Recruiting
Coast Clinical Research, LLC	Bellflower	California	Recruiting
KUR Research, LLC	Bessemer	Alabama	Not yet recruiting
Michigan Center of Medical Research	Bingham Farms	Michigan	Recruiting
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates	Birmingham	Alabama	Recruiting
University of Alabama at Birmingham - School of Medicine	Birmingham	Alabama	Recruiting
Bingham Memorial Hospital	Blackfoot	Idaho	Recruiting
ASR, LLC	Boise	Idaho	Recruiting
Proactive RGV	Brownsville	Texas	Recruiting
KUR Research, LLC	Centreville	Alabama	Not yet recruiting
ObjectiveHealth Clinical Research LLC - Chamblee	Chamblee	Georgia	Not yet recruiting
Atrium Health Cannon Research Cente	Charlotte	North Carolina	Recruiting
Atrium Health Levine Children's Myers Park Pediatrics	Charlotte	North Carolina	Recruiting
Atrium Health - STRIVE Research clinic	Charlotte	North Carolina	Recruiting
Pediatric Associates of Mt. Carmel	Cincinnati	Ohio	Recruiting
University of Missouri	Columbia	Missouri	Recruiting
Kur Research, LLC	Columbia	Maryland	Recruiting
The Pediatric Center	Columbia	Maryland	Not yet recruiting
University of Missouri Pediatrics Clinic-South Providence	Columbia	Missouri	Recruiting
South Texas Clinical Research	Corpus Christi	Texas	Not yet recruiting
UPMC Children's Community Pediatrics Bass Wolfson-Cranberry	Cranberry Township	Pennsylvania	Recruiting
PriMED Clinical Research	Dayton	Ohio	Recruiting
Vida Clinical Studies, LLC	Dearborn Heights	Michigan	Recruiting
Integrity Clinical Network, LLC	Derby	Kansas	Recruiting
Duke Vaccine and Trials Unit	Durham	North Carolina	Recruiting

74 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 8, 2026
Site added
27 sites added (124 total)
97124

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07629440

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Japan

Puerto Rico

United States

Study documents

Changes over time