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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
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En bref

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 participants recherchés124 sites3 pays

Catégories

Maladies infectieuses90%Respiratoire8%Dermatologie2%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Pneumococcal Disease

Éligibilité

SexeTous
Âges42 Days – 211 Days
Volontaires sainsOui

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalPREVENTION
InsuQUADRUPLE (4)
Recrutement3 230 participants recherchés

Promoteur et collaborateurs

  • Pfizer Promoteur

Groupes et 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

  • Produit biologique 20-valent pneumococcal conjugate vaccine (20vPnC)

    20-valent pneumococcal conjugate vaccine (20vPnC)

  • Produit biologique PG4

    Multivalent Pneumococcal Vaccine

Critères de jugement

  1. Critère de jugement principal

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

    Prompted local reactions after each dose

    Délai Day 7

  2. Critère de jugement principal

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

    Prompted systemic events after each dose

    Délai Day 7

  3. Critère de jugement principal

    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

    Délai Dose 1 to 1 month after Dose 3

  4. Critère de jugement principal

    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

    Délai Dose 4 to 1 month after Dose 4

  5. Critère de jugement principal

    Percentage of participants reporting serious adverse events (SAEs)

    SAEs occurring from Dose 1 to 6 months after Dose 4

    Délai Dose 1 to 6 months after Dose 4

  6. Critère de jugement principal

    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

    Délai 1 month after Dose 3

  7. Critère de jugement principal

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

    Pneumococcal IgG GMCs 1 month after Dose 4

    Délai 1 month after Dose 4

  8. Critère de jugement secondaire

    Pneumococcal IgG GMCs 1 month after Dose 3

    Pneumococcal IgG GMCs 1 month after Dose 3

    Délai 1 month after Dose 3

  9. Critère de jugement secondaire

    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

    Délai 1 month after Dose 3

  10. Critère de jugement secondaire

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Délai 1 month after Dose 4

  11. Critère de jugement secondaire

    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

    Délai 1 month after Dose 3

  12. Critère de jugement secondaire

    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

    Délai 1 month after Dose 4

  13. Critère de jugement secondaire

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

    Pneumococcal OPA titers 1 month after Dose 3

    Délai 1 month after Dose 3

  14. Critère de jugement secondaire

    Pneumococcal OPA titers prior to Dose 4

    Pneumococcal OPA titers prior to Dose 4

    Délai Prior to Dose 4

  15. Critère de jugement secondaire

    Pneumococcal OPA titers 1 month after Dose 4

    Pneumococcal OPA titers 1 month after Dose 4

    Délai 1 month after Dose 4

  16. Critère de jugement secondaire

    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

    Délai 1 month after Dose 4

  17. Critère de jugement secondaire

    Pneumococcal IgG concentrations 1 month after Dose 3

    Pneumococcal IgG concentrations 1 month after Dose 3

    Délai 1 month after Dose 3

  18. Critère de jugement secondaire

    Pneumococcal IgG concentrations prior to Dose 4

    Pneumococcal IgG concentrations prior to Dose 4

    Délai Prior to Dose 4

  19. Critère de jugement secondaire

    Pneumococcal IgG concentrations 1 month after Dose 4

    Pneumococcal IgG concentrations 1 month after Dose 4

    Délai 1 month after Dose 4

  20. Critère de jugement secondaire

    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

    Délai Before Dose 4 to 1 month after Dose 4

  21. Critère de jugement secondaire

    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

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

  22. Critère de jugement secondaire

    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

    Délai 1 month after Dose 3

  23. Critère de jugement secondaire

    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

    Délai 1 month after Dose 4

  24. Critère de jugement secondaire

    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

    Délai 1 month after Dose 3

Dates

Date de début29 mai 2026 (réelle)
Achèvement principal5 juin 2029 (estimée)
Achèvement5 juin 2029 (estimée)
Première publication5 juin 2026 (réelle)
Dernière mise à jour8 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

114 sites sont en recrutement

Japan

ÉtablissementVilleÉtat ou régionStatut
Fukui Aiiku HospitalFukuiEn recrutement
Shindo children's clinicFukuokaFukuokaEn recrutement
Fukazawa Pediatric ClinicFukuokaEn recrutement
Nintenkaikagoshima Children's HospitalHiokiKagoshima-kenEn recrutement
Yokoyama Children'S ClinicKasugaFukuokaEn recrutement
Kose Children ClinicKofuYamanashiEn recrutement
Kubota Children's ClinicOsakaEn recrutement
Ohigesenseino Kodomo ClinicSapporoHokkaidoEn recrutement
Futaba ClinicShinjuku-kuTokyoEn recrutement
TOYOTA Memorial HospitalToyota-shiAichi-kenEn recrutement

Puerto Rico

ÉtablissementVilleÉtat ou régionStatut
Clinical Research Investigator GroupBayamónEn recrutement
San Juan Bautista School of Medicine - Clinical Research UnitCaguasEn recrutement
Caguas Clinical ResearchCaguasEn recrutement
Clinical Research Puerto RicoGuayamaEn recrutement
BRCR Global Puerto RicoPonceEn recrutement
Ponce Medical School Foundation Inc./ CAIMED CenterPonceEn recrutement
BRCR Global Puerto RicoSan JuanEn recrutement
San Miguel MedicalTrujillo AltoEn recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Michigan Institute of ResearchAllen ParkMichiganEn recrutement
Medical Research PartnersAmmonIdahoEn recrutement
Advanced Research Center, Inc.AnaheimCaliforniaEn recrutement
The Iowa Clinic.AnkenyIowaEn recrutement
San Gabriel Woman's HealthArcadiaCaliforniaEn recrutement
Childrens Hospital of ColoradoAuroraColoradoEn recrutement
University of Maryland, Baltimore, Center for Vaccine Development and Global HealthBaltimoreMarylandPas encore en recrutement
UPMC Children's Community Pediatrics- BellevueBellevuePennsylvaniaEn recrutement
Coast Clinical Research, LLCBellflowerCaliforniaEn recrutement
KUR Research, LLCBessemerAlabamaPas encore en recrutement
Michigan Center of Medical ResearchBingham FarmsMichiganEn recrutement
Alabama Clinical Therapeutics, LLC Birmingham Pediatric AssociatesBirminghamAlabamaEn recrutement
University of Alabama at Birmingham - School of MedicineBirminghamAlabamaEn recrutement
Bingham Memorial HospitalBlackfootIdahoEn recrutement
ASR, LLCBoiseIdahoEn recrutement
Proactive RGVBrownsvilleTexasEn recrutement
KUR Research, LLCCentrevilleAlabamaPas encore en recrutement
ObjectiveHealth Clinical Research LLC - ChambleeChambleeGeorgiaPas encore en recrutement
Atrium Health Cannon Research CenteCharlotteNorth CarolinaEn recrutement
Atrium Health Levine Children's Myers Park PediatricsCharlotteNorth CarolinaEn recrutement
Atrium Health - STRIVE Research clinicCharlotteNorth CarolinaEn recrutement
Pediatric Associates of Mt. CarmelCincinnatiOhioEn recrutement
University of MissouriColumbiaMissouriEn recrutement
Kur Research, LLCColumbiaMarylandEn recrutement
The Pediatric CenterColumbiaMarylandPas encore en recrutement
University of Missouri Pediatrics Clinic-South ProvidenceColumbiaMissouriEn recrutement
South Texas Clinical ResearchCorpus ChristiTexasPas encore en recrutement
UPMC Children's Community Pediatrics Bass Wolfson-CranberryCranberry TownshipPennsylvaniaEn recrutement
PriMED Clinical ResearchDaytonOhioEn recrutement
Vida Clinical Studies, LLCDearborn HeightsMichiganEn recrutement
Integrity Clinical Network, LLCDerbyKansasEn recrutement
Duke Vaccine and Trials UnitDurhamNorth CarolinaEn recrutement

74 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 8 septembre 2026

    Site ajouté

    27 sites added (124 total)

    97124

Registre: ClinicalTrials.gov · NCT########

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