Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
2018년 11월 30일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
551
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Fukuoka, 일본, 811-1394
- National Hospital Organization Fukuoka National Hospital
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Fukuoka, 일본, 816-0094
- Harada Clinic
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Kumamoto, 일본, 860-0812
- Hattori Pediatric Clinic
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Kumamoto, 일본, 860-0834
- Medical Corporation Seiaikai Seguchi Pediatric Clinic
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Kumamoto, 일본, 862-0924
- Medical Corporation Oukakai Sakuranbo Kodomo Clinic
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Okayama, 일본, 701-0205
- Momotaro Clinic
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Chiba
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Funabashi, Chiba, 일본, 273-0035
- Sunrise Children's Clinic
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Isumi-city, Chiba, 일본, 299-4503
- Sotobo Children's Clinic
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Ehime
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Matsuyama-city, Ehime, 일본, 790-8524
- Matsuyama Red Cross Hospital
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Fukuoka
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Higashi-ku, Fukuoka-city, Fukuoka, 일본, 813-0036
- Fukazawa Pediatric Clinic
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Hiroshima
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Fukuyama, Hiroshima, 일본, 720-8520
- National Hospital Organization Fukuyama Medical Center
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Kure, Hiroshima, 일본, 737-0023
- National Hospital Organization Kure Medical Center
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Hokkaido
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Sapporo, Hokkaido, 일본, 003-0023
- Nakata pediatric clinic
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Sapporo, Hokkaido, 일본, 006-0831
- Watanabe Pediatric Allergy Clinic
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Sapporo, Hokkaido, 일본, 063-0831
- Furuta Children's Clinic
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Sapporo, Hokkaido, 일본, 065-0024
- Motomachi pediatric clinic
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Sapporo, Hokkaido, 일본, 065-8611
- Tenshi Hospital
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Kumamoto
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Kikuchi-gun, Kumamoto, 일본, 869-1102
- Yoshimoto Pediatrist Clinic
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MIE
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Suzuka, MIE, 일본, 510-0235
- Shiroko Clinic
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Tsu, MIE, 일본, 514-0125
- National Mie Hospital
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Tsu, MIE, 일본, 514-1101
- National hospital Organization Mie Chuou Medical Center
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Saitama
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Kumagaya, Saitama, 일본, 360-0018
- Children's Enomoto Clinic
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Kumagaya-city, Saitama, 일본, 360-0812
- Shibuya Clinic
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Tokyo
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Fuchu, Tokyo, 일본, 183-0042
- Sakiyama Children's Clinic
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Ota-ku, Tokyo, 일본, 146-0095
- Okawa Children and Family Clinic
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Setagaya-ku, Tokyo, 일본, 157-8535
- National Center for Child Health and Development
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Setagaya-ku, Tokyo, 일본, 157-0066
- Seijo Sasamoto Pediatric And Allergy Clinic
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Tachikawa-shi, Tokyo, 일본, 190-0002
- Miyata Pediatric Clinic
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Tama, Tokyo, 일본, 206-0011
- Maehara Pediatric Clinic
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Yamanashi
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Kofu, Yamanashi, 일본, 400-0853
- Childrens Clinic of Kose
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Koushu-shi, Yamanashi, 일본, 404-0046
- Medical Corporation Bunpoukai Amemiya Clinic
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Tsuru-shi, Yamanashi, 일본, 402-0025
- Medical corporation Seijinkai Takei Clinic
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
3개월 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
실험적
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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활성 비교기: 2
활성 비교기
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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활성 비교기: 3
Active comparator
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0.5 mL per dose, 4 doses
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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
기간: 1 month after the infant series
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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.
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1 month after the infant series
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
기간: 1 month after the infant series
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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.
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1 month after the infant series
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Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
기간: 1 month after the infant series
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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).
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1 month after the infant series
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
기간: 1 month after the infant series
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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.
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1 month after the infant series
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Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose
기간: 1 month after the toddler dose
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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.
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1 month after the toddler dose
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
기간: 1 month after the toddler dose
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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.
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1 month after the toddler dose
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Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
기간: 1 month after the toddler dose
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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.
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1 month after the toddler dose
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Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series
기간: 1 month after the infant series
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GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
기간: 1 month after the infant series
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GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
기간: 1 month after the toddler dose
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GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
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1 month after the toddler dose
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Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
기간: 1 month after the toddler dose
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GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
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1 month after the toddler dose
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
기간: Within 7 days after Dose 1 of the infant series
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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.
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Within 7 days after Dose 1 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
기간: Within 7 days after Dose 2 of the infant series
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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.
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Within 7 days after Dose 2 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
기간: Within 7 days after Dose 3 of the infant series
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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.
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Within 7 days after Dose 3 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
기간: Within 7 days after the toddler dose
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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.
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Within 7 days after the toddler dose
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
기간: Within 7 days after Dose 1 of infant series
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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.
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Within 7 days after Dose 1 of infant series
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
기간: Within 7 days after Dose 2 of infant series
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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.
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Within 7 days after Dose 2 of infant series
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
기간: Within 7 days after Dose 3 of infant series
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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.
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Within 7 days after Dose 3 of infant series
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Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
기간: Within 7 days after the toddler dose
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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.
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Within 7 days after the toddler dose
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2010년 9월 24일
기본 완료 (실제)
2011년 11월 30일
연구 완료 (실제)
2011년 11월 30일
연구 등록 날짜
최초 제출
2010년 8월 31일
QC 기준을 충족하는 최초 제출
2010년 9월 10일
처음 게시됨 (추정)
2010년 9월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 11월 30일
마지막으로 확인됨
2018년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B1851056
- 6096A1-3024 (기타 식별자: Alias Study Number)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
13-valent pneumococcal conjugate vaccine (13vPnC)에 대한 임상 시험
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PATHUniversity College, London; FHI 360; Medical Research Council Unit, The Gambia; Serum Institute...완전한