Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
2018年11月30日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
551
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Fukuoka、日本、811-1394
- National Hospital Organization Fukuoka National Hospital
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Fukuoka、日本、816-0094
- Harada Clinic
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Kumamoto、日本、860-0812
- Hattori Pediatric Clinic
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Kumamoto、日本、860-0834
- Medical Corporation Seiaikai Seguchi Pediatric Clinic
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Kumamoto、日本、862-0924
- Medical Corporation Oukakai Sakuranbo Kodomo Clinic
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Okayama、日本、701-0205
- Momotaro Clinic
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Chiba
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Funabashi、Chiba、日本、273-0035
- Sunrise Children's Clinic
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Isumi-city、Chiba、日本、299-4503
- Sotobo Children's Clinic
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Ehime
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Matsuyama-city、Ehime、日本、790-8524
- Matsuyama Red Cross Hospital
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Fukuoka
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Higashi-ku, Fukuoka-city、Fukuoka、日本、813-0036
- Fukazawa Pediatric Clinic
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Hiroshima
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Fukuyama、Hiroshima、日本、720-8520
- National Hospital Organization Fukuyama Medical Center
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Kure、Hiroshima、日本、737-0023
- National Hospital Organization Kure Medical Center
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Hokkaido
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Sapporo、Hokkaido、日本、003-0023
- Nakata pediatric clinic
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Sapporo、Hokkaido、日本、006-0831
- Watanabe Pediatric Allergy Clinic
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Sapporo、Hokkaido、日本、063-0831
- Furuta Children's Clinic
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Sapporo、Hokkaido、日本、065-0024
- Motomachi pediatric clinic
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Sapporo、Hokkaido、日本、065-8611
- Tenshi Hospital
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Kumamoto
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Kikuchi-gun、Kumamoto、日本、869-1102
- Yoshimoto Pediatrist Clinic
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MIE
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Suzuka、MIE、日本、510-0235
- Shiroko Clinic
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Tsu、MIE、日本、514-0125
- National Mie Hospital
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Tsu、MIE、日本、514-1101
- National hospital Organization Mie Chuou Medical Center
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Saitama
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Kumagaya、Saitama、日本、360-0018
- Children's Enomoto Clinic
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Kumagaya-city、Saitama、日本、360-0812
- Shibuya Clinic
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Tokyo
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Fuchu、Tokyo、日本、183-0042
- Sakiyama Children's Clinic
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Ota-ku、Tokyo、日本、146-0095
- Okawa Children and Family Clinic
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Setagaya-ku、Tokyo、日本、157-8535
- National Center for Child Health and Development
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Setagaya-ku、Tokyo、日本、157-0066
- Seijo Sasamoto Pediatric And Allergy Clinic
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Tachikawa-shi、Tokyo、日本、190-0002
- Miyata Pediatric Clinic
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Tama、Tokyo、日本、206-0011
- Maehara Pediatric Clinic
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Yamanashi
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Kofu、Yamanashi、日本、400-0853
- Childrens Clinic of Kose
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Koushu-shi、Yamanashi、日本、404-0046
- Medical Corporation Bunpoukai Amemiya Clinic
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Tsuru-shi、Yamanashi、日本、402-0025
- Medical corporation Seijinkai Takei Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
3ヶ月～6ヶ月 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
実験的
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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アクティブコンパレータ：2
アクティブコンパレータ
|
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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アクティブコンパレータ：3
Active comparator
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0.5 mL per dose, 4 doses
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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.
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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
時間枠：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.
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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
時間枠：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).
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1 month after the infant series
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
時間枠：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.
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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
時間枠：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
|
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
時間枠：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.
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
時間枠：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)
時間枠：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.
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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)
時間枠：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.
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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)
時間枠：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
|
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
時間枠：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.
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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)
時間枠：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
|
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2010年9月24日
一次修了 (実際)
2011年11月30日
研究の完了 (実際)
2011年11月30日
試験登録日
最初に提出
2010年8月31日
QC基準を満たした最初の提出物
2010年9月10日
最初の投稿 (見積もり)
2010年9月13日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月19日
QC基準を満たした最後の更新が送信されました
2018年11月30日
最終確認日
2018年11月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- B1851056
- 6096A1-3024 (その他の識別子：Alias Study Number)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。