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Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects

2018年6月28日 更新者：GlaxoSmithKline

Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) 580299 Vaccine in Healthy Chinese Female Subjects

This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group will receive the control.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

750

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

  • 中国
    • Jiangsu
      • Taizhou、Jiangsu、中国、225300
        • GSK Investigational Site

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～17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

女性

説明

Inclusion Criteria:

  • Subjects who the investigator believes that they or their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Healthy Chinese females between and including 9 and 17 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
  • Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
  • Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination.
  • Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and agree to continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., Days 0-29) the first dose of vaccine.
  • 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.
  • A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
  • Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
  • Previous administration of components of the study vaccine.
  • History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

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
実験的：Cervarix Group
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
生物学的：CervarixTM
Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule.
実験的：Placebo Group
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
他の：Control
Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule.

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
Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens
時間枠：One month after the third dose (at Month 7)
Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
One month after the third dose (at Month 7)

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
時間枠：At Month 7
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
At Month 7
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
時間枠：During the 7 days (Days 0 - 6) following each vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
During the 7 days (Days 0 - 6) following each vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
時間枠：During the 7 days (Days 0 - 6) following each vaccination
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
During the 7 days (Days 0 - 6) following each vaccination
Number of Subjects Reporting Medically Significant Conditions (MSCs)
時間枠：Throughout the study period (from Day 0 up to Month 12)

Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

MSCs were collected regardless of causal relationship to vaccination and intensity.
Throughout the study period (from Day 0 up to Month 12)
Number of Subjects Reporting Pregnancies and Pregnancy Outcomes
時間枠：Throughout the study period (from Day 0 up to Month 12)
Throughout the study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
時間枠：Within 30 days (Days 0 - 29) after any vaccination
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Within 30 days (Days 0 - 29) after any vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
時間枠：Throughout the study period (from Day 0 up to Month 12)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Throughout the study period (from Day 0 up to Month 12)

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

GlaxoSmithKline

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

便利なリンク

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10月24日

一次修了 (実際)

2010年12月8日

研究の完了 (実際)

2010年12月8日

試験登録日

最初に提出

2009年10月15日

QC基準を満たした最初の提出物

2009年10月15日

最初の投稿 (見積もり)

2009年10月16日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月17日

QC基準を満たした最後の更新が送信されました

2018年6月28日

最終確認日

2016年9月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 112022

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

  1. 個人参加者データセット
    情報識別子：112022
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. インフォームド コンセント フォーム
    情報識別子：112022
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. データセット仕様
    情報識別子：112022
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 臨床研究報告書
    情報識別子：112022
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 研究プロトコル
    情報識別子：112022
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 統計分析計画
    情報識別子：112022
    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。

CervarixTMの臨床試験

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スポンサーと協力者

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CROs in Mongolia

条件

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薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

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