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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 3,230 مشاركاً124 موقعاً3 دول

الفئات

الأمراض المُعدية90%الجهاز التنفسي8%الأمراض الجلدية2%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Pneumococcal Disease

الأهلية

الجنسالجميع
الأعمار42 Days – 211 Days
المتطوعون الأصحّاءنعم

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيPREVENTION
التعميةQUADRUPLE (4)
التجنيدمطلوب 3,230 مشاركاً

الجهة الراعية والمتعاونون

  • Pfizer الجهة الراعية

الأذرع والتدخلات

  • 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)

التدخلات

  • منتج بيولوجي 20-valent pneumococcal conjugate vaccine (20vPnC)

    20-valent pneumococcal conjugate vaccine (20vPnC)

  • منتج بيولوجي PG4

    Multivalent Pneumococcal Vaccine

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    Prompted local reactions after each dose

    الإطار الزمني Day 7

  2. مقياس النتيجة الأولي

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

    Prompted systemic events after each dose

    الإطار الزمني Day 7

  3. مقياس النتيجة الأولي

    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

    الإطار الزمني Dose 1 to 1 month after Dose 3

  4. مقياس النتيجة الأولي

    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

    الإطار الزمني Dose 4 to 1 month after Dose 4

  5. مقياس النتيجة الأولي

    Percentage of participants reporting serious adverse events (SAEs)

    SAEs occurring from Dose 1 to 6 months after Dose 4

    الإطار الزمني Dose 1 to 6 months after Dose 4

  6. مقياس النتيجة الأولي

    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

    الإطار الزمني 1 month after Dose 3

  7. مقياس النتيجة الأولي

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

    Pneumococcal IgG GMCs 1 month after Dose 4

    الإطار الزمني 1 month after Dose 4

  8. مقياس النتيجة الثانوي

    Pneumococcal IgG GMCs 1 month after Dose 3

    Pneumococcal IgG GMCs 1 month after Dose 3

    الإطار الزمني 1 month after Dose 3

  9. مقياس النتيجة الثانوي

    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

    الإطار الزمني 1 month after Dose 3

  10. مقياس النتيجة الثانوي

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    الإطار الزمني 1 month after Dose 4

  11. مقياس النتيجة الثانوي

    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

    الإطار الزمني 1 month after Dose 3

  12. مقياس النتيجة الثانوي

    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

    الإطار الزمني 1 month after Dose 4

  13. مقياس النتيجة الثانوي

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

    Pneumococcal OPA titers 1 month after Dose 3

    الإطار الزمني 1 month after Dose 3

  14. مقياس النتيجة الثانوي

    Pneumococcal OPA titers prior to Dose 4

    Pneumococcal OPA titers prior to Dose 4

    الإطار الزمني Prior to Dose 4

  15. مقياس النتيجة الثانوي

    Pneumococcal OPA titers 1 month after Dose 4

    Pneumococcal OPA titers 1 month after Dose 4

    الإطار الزمني 1 month after Dose 4

  16. مقياس النتيجة الثانوي

    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

    الإطار الزمني 1 month after Dose 4

  17. مقياس النتيجة الثانوي

    Pneumococcal IgG concentrations 1 month after Dose 3

    Pneumococcal IgG concentrations 1 month after Dose 3

    الإطار الزمني 1 month after Dose 3

  18. مقياس النتيجة الثانوي

    Pneumococcal IgG concentrations prior to Dose 4

    Pneumococcal IgG concentrations prior to Dose 4

    الإطار الزمني Prior to Dose 4

  19. مقياس النتيجة الثانوي

    Pneumococcal IgG concentrations 1 month after Dose 4

    Pneumococcal IgG concentrations 1 month after Dose 4

    الإطار الزمني 1 month after Dose 4

  20. مقياس النتيجة الثانوي

    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

    الإطار الزمني Before Dose 4 to 1 month after Dose 4

  21. مقياس النتيجة الثانوي

    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

    الإطار الزمني From 1 month after Dose 3 to 1 month after Dose 4

  22. مقياس النتيجة الثانوي

    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

    الإطار الزمني 1 month after Dose 3

  23. مقياس النتيجة الثانوي

    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

    الإطار الزمني 1 month after Dose 4

  24. مقياس النتيجة الثانوي

    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

    الإطار الزمني 1 month after Dose 3

التواريخ

تاريخ البدء29 مايو 2026 (فعلي)
الإتمام الأولي5 يونيو 2029 (تقديري)
الإتمام5 يونيو 2029 (تقديري)
أول نشر5 يونيو 2026 (فعلي)
آخر تحديث8 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

114 موقعاً قيد التجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Fukui Aiiku HospitalFukuiقيد التجنيد
Shindo children's clinicFukuokaFukuokaقيد التجنيد
Fukazawa Pediatric ClinicFukuokaقيد التجنيد
Nintenkaikagoshima Children's HospitalHiokiKagoshima-kenقيد التجنيد
Yokoyama Children'S ClinicKasugaFukuokaقيد التجنيد
Kose Children ClinicKofuYamanashiقيد التجنيد
Kubota Children's ClinicOsakaقيد التجنيد
Ohigesenseino Kodomo ClinicSapporoHokkaidoقيد التجنيد
Futaba ClinicShinjuku-kuTokyoقيد التجنيد
TOYOTA Memorial HospitalToyota-shiAichi-kenقيد التجنيد

Puerto Rico

المنشأةالمدينةالولاية أو المنطقةالحالة
Clinical Research Investigator GroupBayamónقيد التجنيد
San Juan Bautista School of Medicine - Clinical Research UnitCaguasقيد التجنيد
Caguas Clinical ResearchCaguasقيد التجنيد
Clinical Research Puerto RicoGuayamaقيد التجنيد
BRCR Global Puerto RicoPonceقيد التجنيد
Ponce Medical School Foundation Inc./ CAIMED CenterPonceقيد التجنيد
BRCR Global Puerto RicoSan Juanقيد التجنيد
San Miguel MedicalTrujillo Altoقيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Michigan Institute of ResearchAllen ParkMichiganقيد التجنيد
Medical Research PartnersAmmonIdahoقيد التجنيد
Advanced Research Center, Inc.AnaheimCaliforniaقيد التجنيد
The Iowa Clinic.AnkenyIowaقيد التجنيد
San Gabriel Woman's HealthArcadiaCaliforniaقيد التجنيد
Childrens Hospital of ColoradoAuroraColoradoقيد التجنيد
University of Maryland, Baltimore, Center for Vaccine Development and Global HealthBaltimoreMarylandلم يبدأ التجنيد بعد
UPMC Children's Community Pediatrics- BellevueBellevuePennsylvaniaقيد التجنيد
Coast Clinical Research, LLCBellflowerCaliforniaقيد التجنيد
KUR Research, LLCBessemerAlabamaلم يبدأ التجنيد بعد
Michigan Center of Medical ResearchBingham FarmsMichiganقيد التجنيد
Alabama Clinical Therapeutics, LLC Birmingham Pediatric AssociatesBirminghamAlabamaقيد التجنيد
University of Alabama at Birmingham - School of MedicineBirminghamAlabamaقيد التجنيد
Bingham Memorial HospitalBlackfootIdahoقيد التجنيد
ASR, LLCBoiseIdahoقيد التجنيد
Proactive RGVBrownsvilleTexasقيد التجنيد
KUR Research, LLCCentrevilleAlabamaلم يبدأ التجنيد بعد
ObjectiveHealth Clinical Research LLC - ChambleeChambleeGeorgiaلم يبدأ التجنيد بعد
Atrium Health Cannon Research CenteCharlotteNorth Carolinaقيد التجنيد
Atrium Health Levine Children's Myers Park PediatricsCharlotteNorth Carolinaقيد التجنيد
Atrium Health - STRIVE Research clinicCharlotteNorth Carolinaقيد التجنيد
Pediatric Associates of Mt. CarmelCincinnatiOhioقيد التجنيد
University of MissouriColumbiaMissouriقيد التجنيد
Kur Research, LLCColumbiaMarylandقيد التجنيد
The Pediatric CenterColumbiaMarylandلم يبدأ التجنيد بعد
University of Missouri Pediatrics Clinic-South ProvidenceColumbiaMissouriقيد التجنيد
South Texas Clinical ResearchCorpus ChristiTexasلم يبدأ التجنيد بعد
UPMC Children's Community Pediatrics Bass Wolfson-CranberryCranberry TownshipPennsylvaniaقيد التجنيد
PriMED Clinical ResearchDaytonOhioقيد التجنيد
Vida Clinical Studies, LLCDearborn HeightsMichiganقيد التجنيد
Integrity Clinical Network, LLCDerbyKansasقيد التجنيد
Duke Vaccine and Trials UnitDurhamNorth Carolinaقيد التجنيد

يُدرَج 74 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 8 سبتمبر 2026

    أُضيف موقع

    27 sites added (124 total)

    97124

السجل: ClinicalTrials.gov · NCT########

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