Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
2018年9月18日 更新者：GlaxoSmithKline
Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study.
The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
調査の概要
詳細な説明
All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.
研究の種類
介入
入学 (実際)
957
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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Mengshan Town、中国
- GSK Investigational Site
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Guangxi
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Wuzhou、Guangxi、中国
- 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
1年～2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 their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
- Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
- Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the 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.
- Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrolment.
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 |
|---|---|
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実験的：Group A
Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age.
Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
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Single dose, intramuscular administration
Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
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アクティブコンパレータ：Group B
Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
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Single dose, intramuscular injection.
Part of the local standard of care.
No outcome measures associated.
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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 Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
時間枠：One month after Poliorix™ booster vaccination.
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A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50).
This outcome measure concerns subjects in the Poliorix Group only.
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One month after Poliorix™ booster vaccination.
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Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
時間枠：Before booster vaccination.
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A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
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Before booster vaccination.
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Antibody Titers Against Poliovirus Type 1, 2 and 3
時間枠：One month after Poliorix™ booster vaccination.
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Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs).
This outcome measure concerns subjects in the Poliorix Group only.
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One month after Poliorix™ booster vaccination.
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Antibody Titers Against Poliovirus Type 1, 2 and 3.
時間枠：Before booster vaccination.
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Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
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Before 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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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
時間枠：Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = Cry when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
This outcome measure concerns subjects in the Poliorix Group only.
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Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
時間枠：Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)].
Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine.
Grade 3 drowsiness = drowsiness that prevented normal activities.
Grade 3 fever = fever (axillary temperature) >39.0°C.
Grade 3 irritability = crying that could not be comforted/ prevented normal activity.
Grade 3 loss of appetite = not eating at all.
Related = symptom assessed by the investigator as causally related to the vaccination.
This outcome measure concerns subjects in the Poliorix Group only.
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Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
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Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
時間枠：Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
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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.
Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study.
Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
This outcome measure concerns subjects in the Poliorix Group only.
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Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
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Number of Subjects With Serious Adverse Events (SAEs)
時間枠：During the entire study period (Day 0 to Month 1).
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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During the entire study period (Day 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。
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
2011年4月25日
一次修了 (実際)
2011年9月19日
研究の完了 (実際)
2011年9月19日
試験登録日
最初に提出
2011年3月24日
QC基準を満たした最初の提出物
2011年3月24日
最初の投稿 (見積もり)
2011年3月25日
学習記録の更新
投稿された最後の更新 (実際)
2019年2月11日
QC基準を満たした最後の更新が送信されました
2018年9月18日
最終確認日
2017年5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
- 114306
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：114306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：114306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：114306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：114306情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
統計分析計画
情報識別子：114306情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
-
研究プロトコル
情報識別子：114306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。