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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. listopadu 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

551

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

3 měsíce až 6 měsíců (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 1
Experimentální
Biologický: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL per dose, 4 doses
Biologický: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
0.5 mL per dose, 4 doses
Aktivní komparátor: 2
Aktivní komparátor
Biologický: 7-valent pneumococcal conjugate vaccine (7vPnC)
0.5 mL per dose, 4 doses
Biologický: DTaP
0.5 mL per dose, 4 doses
Aktivní komparátor: 3
Active comparator
Biologický: DTaP
0.5 mL per dose, 4 doses

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

24. září 2010

Primární dokončení (Aktuální)

30. listopadu 2011

Dokončení studie (Aktuální)

30. listopadu 2011

Termíny zápisu do studia

První předloženo

31. srpna 2010

První předloženo, které splnilo kritéria kontroly kvality

10. září 2010

První zveřejněno (Odhad)

13. září 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. prosince 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. listopadu 2018

Naposledy ověřeno

1. listopadu 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • B1851056
  • 6096A1-3024 (Jiný identifikátor: Alias Study Number)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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