Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
2017年3月1日 更新者：GlaxoSmithKline
Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults
Subjects were previously vaccinated at 11 to 17 years of age.
This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase.
No new subjects will be enrolled.
調査の概要
詳細な説明
Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™.
This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase.
No new studies will be enrolled.
The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.
研究の種類
介入
入学 (実際)
697
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。
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
11年～17年 (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:
- Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
- Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
- History of meningococcal disease; such cases will be documented.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- Subjects who withdrew consent to be contacted for follow-up studies.
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：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 |
|---|---|
|
実験的：Group A
Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
|
A blood sample will be taken yearly at each long-term follow-up visit (i.e.
Year 2 through Year 5) after vaccination during the primary study.
No vaccines are administered in the long-term follow-up study
|
|
アクティブコンパレータ：Group B
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
|
A blood sample will be taken yearly at each long-term follow-up visit (i.e.
Year 2 through Year 5) after vaccination during the primary study.
No vaccines are administered in the long-term follow-up study
|
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 |
|---|---|---|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
時間枠：At Month 24 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses were performed at the GSK Biologicals' laboratory.
|
At Month 24 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
時間枠：At Month 36 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 36 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
時間枠：At Month 48 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 48 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
時間枠：At Month 60 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 60 post primary dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
時間枠：At Months 24, 36, 48 and 60 post primary dose
|
A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
|
At Months 24, 36, 48 and 60 post primary dose
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
時間枠：At Months 24, 36, 48 and 60 post primary dose
|
Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128.
Antibody titers were presented as geometric mean titers (GMTs).
The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
|
At Months 24, 36, 48 and 60 post primary dose
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
時間枠：At Month 24 post primary dose
|
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL).
Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
|
At Month 24 post primary dose
|
|
Antibody Concentrations Against the Vaccine Polysaccharides
時間枠：At Month 24 post primary dose
|
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL).
Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
|
At Month 24 post primary 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
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
2009年9月1日
一次修了 (実際)
2013年5月1日
研究の完了 (実際)
2013年5月1日
試験登録日
最初に提出
2009年9月7日
QC基準を満たした最初の提出物
2009年9月9日
最初の投稿 (見積もり)
2009年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月12日
QC基準を満たした最後の更新が送信されました
2017年3月1日
最終確認日
2016年12月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 112148
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