Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
2018年4月27日 更新者:GlaxoSmithKline
Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.
調査の概要
研究の種類
介入
入学 (実際)
415
段階
- フェーズ 4
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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Berlin、ドイツ、12627
- GSK Investigational Site
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Berlin、ドイツ、13507
- GSK Investigational Site
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Berlin、ドイツ、13355
- GSK Investigational Site
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Baden-Wuerttemberg
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Ettenheim、Baden-Wuerttemberg、ドイツ、77955
- GSK Investigational Site
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Kehl、Baden-Wuerttemberg、ドイツ、77694
- GSK Investigational Site
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Oberkirch、Baden-Wuerttemberg、ドイツ、77704
- GSK Investigational Site
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Offenburg、Baden-Wuerttemberg、ドイツ、77654
- GSK Investigational Site
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Bayern
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Cham、Bayern、ドイツ、93413
- GSK Investigational Site
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Kaufering、Bayern、ドイツ、86916
- GSK Investigational Site
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Landshut、Bayern、ドイツ、84032
- GSK Investigational Site
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Muenchen、Bayern、ドイツ、80939
- GSK Investigational Site
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Olching、Bayern、ドイツ、82140
- GSK Investigational Site
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Weilheim、Bayern、ドイツ、82362
- GSK Investigational Site
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Hessen
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Eschwege、Hessen、ドイツ、37269
- GSK Investigational Site
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Koenigstein、Hessen、ドイツ、61462
- GSK Investigational Site
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Niedersachsen
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Salzgitter、Niedersachsen、ドイツ、38226
- GSK Investigational Site
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Wolfenbuettel、Niedersachsen、ドイツ、38302
- GSK Investigational Site
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Nordrhein-Westfalen
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Erkrath、Nordrhein-Westfalen、ドイツ、40699
- GSK Investigational Site
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Goch、Nordrhein-Westfalen、ドイツ、47574
- GSK Investigational Site
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Guetersloh、Nordrhein-Westfalen、ドイツ、33332
- GSK Investigational Site
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Heiligenhaus、Nordrhein-Westfalen、ドイツ、42579
- GSK Investigational Site
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Kleve-Materborn、Nordrhein-Westfalen、ドイツ、47533
- GSK Investigational Site
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Krefeld、Nordrhein-Westfalen、ドイツ、47798
- GSK Investigational Site
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Loehne、Nordrhein-Westfalen、ドイツ、32584
- GSK Investigational Site
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Muenster、Nordrhein-Westfalen、ドイツ、48159
- GSK Investigational Site
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Willich、Nordrhein-Westfalen、ドイツ、47877
- GSK Investigational Site
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Rheinland-Pfalz
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Bad Kreuznach、Rheinland-Pfalz、ドイツ、55543
- GSK Investigational Site
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Frankenthal、Rheinland-Pfalz、ドイツ、67227
- GSK Investigational Site
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Mainz、Rheinland-Pfalz、ドイツ、55131
- GSK Investigational Site
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Trier、Rheinland-Pfalz、ドイツ、54294
- GSK Investigational Site
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Worms、Rheinland-Pfalz、ドイツ、67547
- GSK Investigational Site
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Worms、Rheinland-Pfalz、ドイツ、67549
- GSK Investigational Site
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Sachsen
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Dresden、Sachsen、ドイツ、01307
- GSK Investigational Site
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Dresden、Sachsen、ドイツ、01169
- GSK Investigational Site
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Schleswig-Holstein
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Brunsbuettel、Schleswig-Holstein、ドイツ、25541
- GSK Investigational Site
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Flensburg、Schleswig-Holstein、ドイツ、24937
- GSK Investigational Site
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Flensburg、Schleswig-Holstein、ドイツ、24939
- GSK Investigational Site
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Flensburg、Schleswig-Holstein、ドイツ、24943
- GSK Investigational Site
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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
9年~13年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
- Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
- History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: hypersensitivity reaction to any component of the vaccine, encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
- Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
- Acute disease at the time of enrolment.
- Pregnant or lactating female.
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:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
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:BOOSTRIX-POLIO GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
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A single booster dose of dTpa-IPV vaccine will be administered to all subjects.
IM administration in the deltoid muscle of the non-dominant arm.
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実験的:BOOSTRIX + IPV MÉRIEUX GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
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A single booster dose of dTpa-IPV vaccine will be administered to all subjects.
IM administration in the deltoid muscle of the non-dominant arm.
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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 |
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Number of Subjects With Any Grade 3 Solicited Local Symptoms
時間枠:During the 4-day (Days 0-3) follow-up period after booster vaccination
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Assessed solicited local symptoms were pain, redness and swelling.
Grade 3 Pain: Pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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During the 4-day (Days 0-3) follow-up period after booster vaccination
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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何らかの局所症状があると考えられる被験者の数
時間枠:追加ワクチン接種後の4日間(0~3日目)の追跡期間中
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評価された局所症状は、痛み、発赤、腫れでした。
任意 = 強度グレードに関係なく症状が発生。
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追加ワクチン接種後の4日間(0~3日目)の追跡期間中
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Number of Subjects With Any Solicited General Symptoms
時間枠:During the 4-day (Days 0-3) follow-up period after booster vaccination
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Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
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During the 4-day (Days 0-3) follow-up period after booster vaccination
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Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
時間枠:Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA).
Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-D and Anti-T Antibody Concentrations
時間枠:Prior to (Month 0) and one month after (Month 1) booster vaccination
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Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
時間枠:Prior to (Month 0) and one month after (Month 1) booster vaccination
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A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
時間枠:Prior to (Month 0) and one month after (Month 1) booster vaccination
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Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
時間枠:Prior to (Month 0) and one month after (Month 1) booster vaccination
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A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Anti-Polio 1, 2 and 3 Antibody Titers
時間枠:Prior to (Month 0) and one month after (Month 1) booster vaccination
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Antibody titers were presented as geometric mean titers (GMTs).
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Prior to (Month 0) and one month after (Month 1) booster vaccination
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Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
時間枠:One month after booster vaccination (At Month 1)
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Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).
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One month after booster vaccination (At Month 1)
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Number of Subjects With Unsolicited Adverse Events (AEs)
時間枠:During the 31-day (Days 0-30) follow-up period after booster vaccination
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AEs results are presented for all subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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During the 31-day (Days 0-30) follow-up period after booster vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
時間枠:During the entire booster period (Month 0 to Month 1)
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Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the entire booster period (Month 0 to Month 1)
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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。
一般刊行物
- Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
- Knuf M, Baine Y, Bianco V, Boutriau D, Miller JM. Antibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young children. Hum Vaccin Immunother. 2012 Jul;8(7):866-72. doi: 10.4161/hv.20229. Epub 2012 Apr 9.
- Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.
- Knuf M et al. The repeated administration of a reduced antigen content diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (dTpa-IPV; BoostrixTM IPV) in adolescents. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
- Knuf M, Vetter V, Celzo F, Ramakrishnan G, Van Der Meeren O, Jacquet JM. Repeated administration of a reduced-antigen-content diphtheria-tetanus-acellular pertussis and poliomyelitis vaccine (dTpa-IPV; Boostrix IPV). Hum Vaccin. 2010 Jul;6(7):554-61. doi: 10.4161/hv.6.7.11760.
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)
2008年2月1日
一次修了 (実際)
2008年7月8日
研究の完了 (実際)
2008年7月8日
試験登録日
最初に提出
2008年3月6日
QC基準を満たした最初の提出物
2008年3月6日
最初の投稿 (見積もり)
2008年3月13日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月6日
QC基準を満たした最後の更新が送信されました
2018年4月27日
最終確認日
2017年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 110947
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
試験データ・資料
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データセット仕様
情報識別子:110947情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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臨床研究報告書
情報識別子:110947情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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インフォームド コンセント フォーム
情報識別子:110947情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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個人参加者データセット
情報識別子:110947情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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研究プロトコル
情報識別子:110947情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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統計分析計画
情報識別子:110947情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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注釈付き症例報告書
情報識別子:110947情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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。
Boostrix-Polioの臨床試験
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GlaxoSmithKline完了呼吸器合胞体ウイルス感染症アメリカ, ベルギー, カナダ
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GlaxoSmithKline完了破傷風 | ジフテリア | 無細胞百日咳 | ジフテリア・破傷風・無細胞百日咳ワクチンオーストラリア
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St George's, University of LondonEuropean Society for Paediatric Infectious Diseasesわからない
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London School of Hygiene and Tropical MedicineRadboud University Medical Center; University of Turku; Imperial College London; University of Oxford と他の協力者積極的、募集していない