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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
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In breve

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…

Fase 33230 partecipanti ricercati124 centri3 paesi

Categorie

Malattie infettive90%Apparato respiratorio8%Dermatologia2%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Pneumococcal Disease

Idoneità

SessoTutti
Età42 Days – 211 Days
Volontari saniSì

Idoneità come riportata nel registro

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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principalePREVENTION
MascheramentoQUADRUPLE (4)
Arruolamento3230 partecipanti ricercati

Sponsor e collaboratori

  • Pfizer Sponsor

Bracci e interventi

  • 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)

Interventi

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

    20-valent pneumococcal conjugate vaccine (20vPnC)

  • Biologico PG4

    Multivalent Pneumococcal Vaccine

Esiti misurati

  1. Esito primario

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

    Prompted local reactions after each dose

    Orizzonte temporale Day 7

  2. Esito primario

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

    Prompted systemic events after each dose

    Orizzonte temporale Day 7

  3. Esito primario

    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

    Orizzonte temporale Dose 1 to 1 month after Dose 3

  4. Esito primario

    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

    Orizzonte temporale Dose 4 to 1 month after Dose 4

  5. Esito primario

    Percentage of participants reporting serious adverse events (SAEs)

    SAEs occurring from Dose 1 to 6 months after Dose 4

    Orizzonte temporale Dose 1 to 6 months after Dose 4

  6. Esito primario

    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

    Orizzonte temporale 1 month after Dose 3

  7. Esito primario

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

    Pneumococcal IgG GMCs 1 month after Dose 4

    Orizzonte temporale 1 month after Dose 4

  8. Esito secondario

    Pneumococcal IgG GMCs 1 month after Dose 3

    Pneumococcal IgG GMCs 1 month after Dose 3

    Orizzonte temporale 1 month after Dose 3

  9. Esito secondario

    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

    Orizzonte temporale 1 month after Dose 3

  10. Esito secondario

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Orizzonte temporale 1 month after Dose 4

  11. Esito secondario

    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

    Orizzonte temporale 1 month after Dose 3

  12. Esito secondario

    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

    Orizzonte temporale 1 month after Dose 4

  13. Esito secondario

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

    Pneumococcal OPA titers 1 month after Dose 3

    Orizzonte temporale 1 month after Dose 3

  14. Esito secondario

    Pneumococcal OPA titers prior to Dose 4

    Pneumococcal OPA titers prior to Dose 4

    Orizzonte temporale Prior to Dose 4

  15. Esito secondario

    Pneumococcal OPA titers 1 month after Dose 4

    Pneumococcal OPA titers 1 month after Dose 4

    Orizzonte temporale 1 month after Dose 4

  16. Esito secondario

    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

    Orizzonte temporale 1 month after Dose 4

  17. Esito secondario

    Pneumococcal IgG concentrations 1 month after Dose 3

    Pneumococcal IgG concentrations 1 month after Dose 3

    Orizzonte temporale 1 month after Dose 3

  18. Esito secondario

    Pneumococcal IgG concentrations prior to Dose 4

    Pneumococcal IgG concentrations prior to Dose 4

    Orizzonte temporale Prior to Dose 4

  19. Esito secondario

    Pneumococcal IgG concentrations 1 month after Dose 4

    Pneumococcal IgG concentrations 1 month after Dose 4

    Orizzonte temporale 1 month after Dose 4

  20. Esito secondario

    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

    Orizzonte temporale Before Dose 4 to 1 month after Dose 4

  21. Esito secondario

    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

    Orizzonte temporale From 1 month after Dose 3 to 1 month after Dose 4

  22. Esito secondario

    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

    Orizzonte temporale 1 month after Dose 3

  23. Esito secondario

    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

    Orizzonte temporale 1 month after Dose 4

  24. Esito secondario

    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

    Orizzonte temporale 1 month after Dose 3

Date

Data di inizio29 maggio 2026 (effettiva)
Conclusione primaria5 giugno 2029 (stimata)
Conclusione5 giugno 2029 (stimata)
Prima pubblicazione5 giugno 2026 (effettiva)
Ultimo aggiornamento8 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

114 centri stanno reclutando

Japan

StrutturaCittàStato o regioneStato
Fukui Aiiku HospitalFukuiIn reclutamento
Shindo children's clinicFukuokaFukuokaIn reclutamento
Fukazawa Pediatric ClinicFukuokaIn reclutamento
Nintenkaikagoshima Children's HospitalHiokiKagoshima-kenIn reclutamento
Yokoyama Children'S ClinicKasugaFukuokaIn reclutamento
Kose Children ClinicKofuYamanashiIn reclutamento
Kubota Children's ClinicOsakaIn reclutamento
Ohigesenseino Kodomo ClinicSapporoHokkaidoIn reclutamento
Futaba ClinicShinjuku-kuTokyoIn reclutamento
TOYOTA Memorial HospitalToyota-shiAichi-kenIn reclutamento

Puerto Rico

StrutturaCittàStato o regioneStato
Clinical Research Investigator GroupBayamónIn reclutamento
San Juan Bautista School of Medicine - Clinical Research UnitCaguasIn reclutamento
Caguas Clinical ResearchCaguasIn reclutamento
Clinical Research Puerto RicoGuayamaIn reclutamento
BRCR Global Puerto RicoPonceIn reclutamento
Ponce Medical School Foundation Inc./ CAIMED CenterPonceIn reclutamento
BRCR Global Puerto RicoSan JuanIn reclutamento
San Miguel MedicalTrujillo AltoIn reclutamento

United States

StrutturaCittàStato o regioneStato
Michigan Institute of ResearchAllen ParkMichiganIn reclutamento
Medical Research PartnersAmmonIdahoIn reclutamento
Advanced Research Center, Inc.AnaheimCaliforniaIn reclutamento
The Iowa Clinic.AnkenyIowaIn reclutamento
San Gabriel Woman's HealthArcadiaCaliforniaIn reclutamento
Childrens Hospital of ColoradoAuroraColoradoIn reclutamento
University of Maryland, Baltimore, Center for Vaccine Development and Global HealthBaltimoreMarylandNon ancora in reclutamento
UPMC Children's Community Pediatrics- BellevueBellevuePennsylvaniaIn reclutamento
Coast Clinical Research, LLCBellflowerCaliforniaIn reclutamento
KUR Research, LLCBessemerAlabamaNon ancora in reclutamento
Michigan Center of Medical ResearchBingham FarmsMichiganIn reclutamento
Alabama Clinical Therapeutics, LLC Birmingham Pediatric AssociatesBirminghamAlabamaIn reclutamento
University of Alabama at Birmingham - School of MedicineBirminghamAlabamaIn reclutamento
Bingham Memorial HospitalBlackfootIdahoIn reclutamento
ASR, LLCBoiseIdahoIn reclutamento
Proactive RGVBrownsvilleTexasIn reclutamento
KUR Research, LLCCentrevilleAlabamaNon ancora in reclutamento
ObjectiveHealth Clinical Research LLC - ChambleeChambleeGeorgiaNon ancora in reclutamento
Atrium Health Cannon Research CenteCharlotteNorth CarolinaIn reclutamento
Atrium Health Levine Children's Myers Park PediatricsCharlotteNorth CarolinaIn reclutamento
Atrium Health - STRIVE Research clinicCharlotteNorth CarolinaIn reclutamento
Pediatric Associates of Mt. CarmelCincinnatiOhioIn reclutamento
University of MissouriColumbiaMissouriIn reclutamento
Kur Research, LLCColumbiaMarylandIn reclutamento
The Pediatric CenterColumbiaMarylandNon ancora in reclutamento
University of Missouri Pediatrics Clinic-South ProvidenceColumbiaMissouriIn reclutamento
South Texas Clinical ResearchCorpus ChristiTexasNon ancora in reclutamento
UPMC Children's Community Pediatrics Bass Wolfson-CranberryCranberry TownshipPennsylvaniaIn reclutamento
PriMED Clinical ResearchDaytonOhioIn reclutamento
Vida Clinical Studies, LLCDearborn HeightsMichiganIn reclutamento
Integrity Clinical Network, LLCDerbyKansasIn reclutamento
Duke Vaccine and Trials UnitDurhamNorth CarolinaIn reclutamento

Nella scheda del registro sono indicati altri 74 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 8 settembre 2026

    Centro aggiunto

    27 sites added (124 total)

    97124

Registro: ClinicalTrials.gov · NCT########

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