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Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

30. november 2018 opdateret af: Pfizer

A Phase 3, Randomized, Active-controlled, Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine Given With Dtap Compared To Open-label Dtap In Healthy Japanese Infants

Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

551

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Fukuoka, Japan, 811-1394
        • National Hospital Organization Fukuoka National Hospital
      • Fukuoka, Japan, 816-0094
        • Harada Clinic
      • Kumamoto, Japan, 860-0812
        • Hattori Pediatric Clinic
      • Kumamoto, Japan, 860-0834
        • Medical Corporation Seiaikai Seguchi Pediatric Clinic
      • Kumamoto, Japan, 862-0924
        • Medical Corporation Oukakai Sakuranbo Kodomo Clinic
      • Okayama, Japan, 701-0205
        • Momotaro Clinic
    • Chiba
      • Funabashi, Chiba, Japan, 273-0035
        • Sunrise Children's Clinic
      • Isumi-city, Chiba, Japan, 299-4503
        • Sotobo Children's Clinic
    • Ehime
      • Matsuyama-city, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital
    • Fukuoka
      • Higashi-ku, Fukuoka-city, Fukuoka, Japan, 813-0036
        • Fukazawa Pediatric Clinic
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-8520
        • National Hospital Organization Fukuyama Medical Center
      • Kure, Hiroshima, Japan, 737-0023
        • National Hospital Organization Kure Medical Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0023
        • Nakata pediatric clinic
      • Sapporo, Hokkaido, Japan, 006-0831
        • Watanabe Pediatric Allergy Clinic
      • Sapporo, Hokkaido, Japan, 063-0831
        • Furuta Children's Clinic
      • Sapporo, Hokkaido, Japan, 065-0024
        • Motomachi pediatric clinic
      • Sapporo, Hokkaido, Japan, 065-8611
        • Tenshi Hospital
    • Kumamoto
      • Kikuchi-gun, Kumamoto, Japan, 869-1102
        • Yoshimoto Pediatrist Clinic
    • MIE
      • Suzuka, MIE, Japan, 510-0235
        • Shiroko Clinic
      • Tsu, MIE, Japan, 514-0125
        • National Mie Hospital
      • Tsu, MIE, Japan, 514-1101
        • National hospital Organization Mie Chuou Medical Center
    • Saitama
      • Kumagaya, Saitama, Japan, 360-0018
        • Children's Enomoto Clinic
      • Kumagaya-city, Saitama, Japan, 360-0812
        • Shibuya Clinic
    • Tokyo
      • Fuchu, Tokyo, Japan, 183-0042
        • Sakiyama Children's Clinic
      • Ota-ku, Tokyo, Japan, 146-0095
        • Okawa Children and Family Clinic
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • National Center for Child Health and Development
      • Setagaya-ku, Tokyo, Japan, 157-0066
        • Seijo Sasamoto Pediatric And Allergy Clinic
      • Tachikawa-shi, Tokyo, Japan, 190-0002
        • Miyata Pediatric Clinic
      • Tama, Tokyo, Japan, 206-0011
        • Maehara Pediatric Clinic
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-0853
        • Childrens Clinic of Kose
      • Koushu-shi, Yamanashi, Japan, 404-0046
        • Medical Corporation Bunpoukai Amemiya Clinic
      • Tsuru-shi, Yamanashi, Japan, 402-0025
        • Medical corporation Seijinkai Takei Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 måneder til 6 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female subjects between 3 to 6 months of age at the enrollment.
  • Available for the entire study period and whose parent/legal guardian can be reached by telephone.
  • Healthy infant as determined by medical history, physical examination, and judgement of the investigator.

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
  • History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
  • Infant who is a direct descendant (child, grandchild) of the study site personnel.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Eksperimentel
Biologisk: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL per dose, 4 doses
Biologisk: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
0.5 mL per dose, 4 doses
Aktiv komparator: 2
Aktiv komparator
Biologisk: 7-valent pneumococcal conjugate vaccine (7vPnC)
0.5 mL per dose, 4 doses
Biologisk: DTaP
0.5 mL per dose, 4 doses
Aktiv komparator: 3
Active comparator
Biologisk: DTaP
0.5 mL per dose, 4 doses

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series
Tidsramme: 1 month after the infant series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
1 month after the infant series
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Tidsramme: 1 month after the infant series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
1 month after the infant series
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Tidsramme: 1 month after the infant series
Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).
1 month after the infant series

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Tidsramme: 1 month after the infant series
Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
1 month after the infant series
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose
Tidsramme: 1 month after the toddler dose
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
1 month after the toddler dose
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Tidsramme: 1 month after the toddler dose
Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
1 month after the toddler dose
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Tidsramme: 1 month after the toddler dose
Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series
Tidsramme: 1 month after the infant series
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
Tidsramme: 1 month after the infant series
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
1 month after the infant series
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Tidsramme: 1 month after the toddler dose
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
1 month after the toddler dose
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
Tidsramme: 1 month after the toddler dose
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
1 month after the toddler dose

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Tidsramme: Within 7 days after Dose 1 of the infant series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 7 days after Dose 1 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Tidsramme: Within 7 days after Dose 2 of the infant series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 7 days after Dose 2 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Tidsramme: Within 7 days after Dose 3 of the infant series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 7 days after Dose 3 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Tidsramme: Within 7 days after the toddler dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Within 7 days after the toddler dose
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Tidsramme: Within 7 days after Dose 1 of infant series
Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Dose 1 of infant series
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Tidsramme: Within 7 days after Dose 2 of infant series
Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Dose 2 of infant series
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Tidsramme: Within 7 days after Dose 3 of infant series
Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after Dose 3 of infant series
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Tidsramme: Within 7 days after the toddler dose
Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 7 days after the toddler dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. september 2010

Primær færdiggørelse (Faktiske)

30. november 2011

Studieafslutning (Faktiske)

30. november 2011

Datoer for studieregistrering

Først indsendt

31. august 2010

Først indsendt, der opfyldte QC-kriterier

10. september 2010

Først opslået (Skøn)

13. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B1851056
  • 6096A1-3024 (Anden identifikator: Alias Study Number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med 13-valent pneumococcal conjugate vaccine (13vPnC)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner