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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

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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…

Phase 33.230 Teilnehmende gesucht124 Studienzentren3 Länder

Kategorien

Infektionskrankheiten90%Atemwege8%Dermatologie2%

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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.

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

Zusammenfassung

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.

Erkrankungen

  • Pneumococcal Disease

Eignung

GeschlechtAlle
Alter42 Days – 211 Days
Gesunde FreiwilligeJa

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielPREVENTION
VerblindungQUADRUPLE (4)
Teilnahme3.230 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Pfizer Sponsor

Studienarme und Interventionen

  • 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)

Interventionen

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

    20-valent pneumococcal conjugate vaccine (20vPnC)

  • Biologikum PG4

    Multivalent Pneumococcal Vaccine

Endpunkte

  1. Primärer Endpunkt

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

    Prompted local reactions after each dose

    Zeitrahmen Day 7

  2. Primärer Endpunkt

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

    Prompted systemic events after each dose

    Zeitrahmen Day 7

  3. Primärer Endpunkt

    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

    Zeitrahmen Dose 1 to 1 month after Dose 3

  4. Primärer Endpunkt

    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

    Zeitrahmen Dose 4 to 1 month after Dose 4

  5. Primärer Endpunkt

    Percentage of participants reporting serious adverse events (SAEs)

    SAEs occurring from Dose 1 to 6 months after Dose 4

    Zeitrahmen Dose 1 to 6 months after Dose 4

  6. Primärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 3

  7. Primärer Endpunkt

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

    Pneumococcal IgG GMCs 1 month after Dose 4

    Zeitrahmen 1 month after Dose 4

  8. Sekundärer Endpunkt

    Pneumococcal IgG GMCs 1 month after Dose 3

    Pneumococcal IgG GMCs 1 month after Dose 3

    Zeitrahmen 1 month after Dose 3

  9. Sekundärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 3

  10. Sekundärer Endpunkt

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Zeitrahmen 1 month after Dose 4

  11. Sekundärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 3

  12. Sekundärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 4

  13. Sekundärer Endpunkt

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

    Pneumococcal OPA titers 1 month after Dose 3

    Zeitrahmen 1 month after Dose 3

  14. Sekundärer Endpunkt

    Pneumococcal OPA titers prior to Dose 4

    Pneumococcal OPA titers prior to Dose 4

    Zeitrahmen Prior to Dose 4

  15. Sekundärer Endpunkt

    Pneumococcal OPA titers 1 month after Dose 4

    Pneumococcal OPA titers 1 month after Dose 4

    Zeitrahmen 1 month after Dose 4

  16. Sekundärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 4

  17. Sekundärer Endpunkt

    Pneumococcal IgG concentrations 1 month after Dose 3

    Pneumococcal IgG concentrations 1 month after Dose 3

    Zeitrahmen 1 month after Dose 3

  18. Sekundärer Endpunkt

    Pneumococcal IgG concentrations prior to Dose 4

    Pneumococcal IgG concentrations prior to Dose 4

    Zeitrahmen Prior to Dose 4

  19. Sekundärer Endpunkt

    Pneumococcal IgG concentrations 1 month after Dose 4

    Pneumococcal IgG concentrations 1 month after Dose 4

    Zeitrahmen 1 month after Dose 4

  20. Sekundärer Endpunkt

    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

    Zeitrahmen Before Dose 4 to 1 month after Dose 4

  21. Sekundärer Endpunkt

    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

    Zeitrahmen From 1 month after Dose 3 to 1 month after Dose 4

  22. Sekundärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 3

  23. Sekundärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 4

  24. Sekundärer Endpunkt

    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

    Zeitrahmen 1 month after Dose 3

Daten

Startdatum29. Mai 2026 (tatsächlich)
Primärer Abschluss5. Juni 2029 (geschätzt)
Abschluss5. Juni 2029 (geschätzt)
Erstveröffentlichung5. Juni 2026 (tatsächlich)
Zuletzt aktualisiert8. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

114 Studienzentren rekrutieren

Japan

EinrichtungStadtBundesland oder RegionStatus
Fukui Aiiku HospitalFukuiRekrutiert
Shindo children's clinicFukuokaFukuokaRekrutiert
Fukazawa Pediatric ClinicFukuokaRekrutiert
Nintenkaikagoshima Children's HospitalHiokiKagoshima-kenRekrutiert
Yokoyama Children'S ClinicKasugaFukuokaRekrutiert
Kose Children ClinicKofuYamanashiRekrutiert
Kubota Children's ClinicOsakaRekrutiert
Ohigesenseino Kodomo ClinicSapporoHokkaidoRekrutiert
Futaba ClinicShinjuku-kuTokyoRekrutiert
TOYOTA Memorial HospitalToyota-shiAichi-kenRekrutiert

Puerto Rico

EinrichtungStadtBundesland oder RegionStatus
Clinical Research Investigator GroupBayamónRekrutiert
San Juan Bautista School of Medicine - Clinical Research UnitCaguasRekrutiert
Caguas Clinical ResearchCaguasRekrutiert
Clinical Research Puerto RicoGuayamaRekrutiert
BRCR Global Puerto RicoPonceRekrutiert
Ponce Medical School Foundation Inc./ CAIMED CenterPonceRekrutiert
BRCR Global Puerto RicoSan JuanRekrutiert
San Miguel MedicalTrujillo AltoRekrutiert

United States

EinrichtungStadtBundesland oder RegionStatus
Michigan Institute of ResearchAllen ParkMichiganRekrutiert
Medical Research PartnersAmmonIdahoRekrutiert
Advanced Research Center, Inc.AnaheimCaliforniaRekrutiert
The Iowa Clinic.AnkenyIowaRekrutiert
San Gabriel Woman's HealthArcadiaCaliforniaRekrutiert
Childrens Hospital of ColoradoAuroraColoradoRekrutiert
University of Maryland, Baltimore, Center for Vaccine Development and Global HealthBaltimoreMarylandRekrutierung noch nicht begonnen
UPMC Children's Community Pediatrics- BellevueBellevuePennsylvaniaRekrutiert
Coast Clinical Research, LLCBellflowerCaliforniaRekrutiert
KUR Research, LLCBessemerAlabamaRekrutierung noch nicht begonnen
Michigan Center of Medical ResearchBingham FarmsMichiganRekrutiert
Alabama Clinical Therapeutics, LLC Birmingham Pediatric AssociatesBirminghamAlabamaRekrutiert
University of Alabama at Birmingham - School of MedicineBirminghamAlabamaRekrutiert
Bingham Memorial HospitalBlackfootIdahoRekrutiert
ASR, LLCBoiseIdahoRekrutiert
Proactive RGVBrownsvilleTexasRekrutiert
KUR Research, LLCCentrevilleAlabamaRekrutierung noch nicht begonnen
ObjectiveHealth Clinical Research LLC - ChambleeChambleeGeorgiaRekrutierung noch nicht begonnen
Atrium Health Cannon Research CenteCharlotteNorth CarolinaRekrutiert
Atrium Health Levine Children's Myers Park PediatricsCharlotteNorth CarolinaRekrutiert
Atrium Health - STRIVE Research clinicCharlotteNorth CarolinaRekrutiert
Pediatric Associates of Mt. CarmelCincinnatiOhioRekrutiert
University of MissouriColumbiaMissouriRekrutiert
Kur Research, LLCColumbiaMarylandRekrutiert
The Pediatric CenterColumbiaMarylandRekrutierung noch nicht begonnen
University of Missouri Pediatrics Clinic-South ProvidenceColumbiaMissouriRekrutiert
South Texas Clinical ResearchCorpus ChristiTexasRekrutierung noch nicht begonnen
UPMC Children's Community Pediatrics Bass Wolfson-CranberryCranberry TownshipPennsylvaniaRekrutiert
PriMED Clinical ResearchDaytonOhioRekrutiert
Vida Clinical Studies, LLCDearborn HeightsMichiganRekrutiert
Integrity Clinical Network, LLCDerbyKansasRekrutiert
Duke Vaccine and Trials UnitDurhamNorth CarolinaRekrutiert

74 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 8. September 2026

    Studienzentrum hinzugefügt

    27 sites added (124 total)

    97124

Register: ClinicalTrials.gov · NCT########

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