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Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

2019년 6월 6일 업데이트: GlaxoSmithKline

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.

연구 유형

중재적

등록 (실제)

137

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • GSK Investigational Site
      • Golden, Colorado, 미국, 80401
        • GSK Investigational Site
    • Florida
      • Coral Gables, Florida, 미국, 33134
        • GSK Investigational Site
      • Miami, Florida, 미국, 33136
        • GSK Investigational Site
    • Georgia
      • Augusta, Georgia, 미국, 30912
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, 미국, 52242
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, 미국, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, 미국, 40004
        • GSK Investigational Site
      • Louisville, Kentucky, 미국, 40202
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, 미국, 68131
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • GSK Investigational Site
    • North Carolina
      • New Bern, North Carolina, 미국, 28562
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, 미국, 44122
        • GSK Investigational Site
    • Pennsylvania
      • Carnegie, Pennsylvania, 미국, 15106
        • GSK Investigational Site
      • Erie, Pennsylvania, 미국, 16508
        • GSK Investigational Site
      • Erie, Pennsylvania, 미국, 16507
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, 미국, 15236
        • GSK Investigational Site
    • Texas
      • Houston, Texas, 미국, 77030
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, 미국, 84109
        • GSK Investigational Site
      • Salt Lake City, Utah, 미국, 84121
        • GSK Investigational Site
    • Washington
      • Wenatchee, Washington, 미국, 98801
        • GSK Investigational Site
  • 캐나다
      • Quebec, 캐나다, G1S 2L6
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, 캐나다, T5A 4L8
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V6H 3N1
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3K 6R8
        • GSK Investigational Site
      • Truro, Nova Scotia, 캐나다, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Waterloo, Ontario, 캐나다, N2L 6H6
        • GSK Investigational Site
    • Quebec
      • Sherbrooke, Quebec, 캐나다, J1H 1Z1
        • GSK Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

26년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A subject previously enrolled in study NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which the vaccine is licensed.
  • Written informed consent obtained from the subject
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days (i.e., Day 0-29) of each dose of vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrolment will be deferred until the subject is outside of specified window.
  • 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.

NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:

  • if they test positive for oncogenic HPV infection, but display normal cervical cytology at their concluding HPV-015 study end visit;

  • if they are pregnant so that no cervical sample can be taken at their concluding HPV-015 study end visit;

    • Previous administration of any components of the vaccine.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • Cancer or autoimmune disease under treatment.
    • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
    • History of any neurological disorders or seizures.
    • Acute disease and/or fever at the time of enrolment.
    • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Cervarix Group
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
생물학적: GSK580299(서바릭스)
3회 스케쥴 근육주사

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
기간: During the entire study period (from Day 0 up to Month 12)
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
기간: During the entire study period (from Day 0 up to Month 12)
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
기간: During the entire study period (from Day 0 up to Month 12)
pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies
기간: During the entire study period (from Day 0 up to Month 12)
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
During the entire study period (from Day 0 up to Month 12)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2011년 4월 1일

기본 완료 (실제)

2017년 11월 23일

연구 완료 (실제)

2017년 11월 23일

연구 등록 날짜

최초 제출

2010년 8월 26일

QC 기준을 충족하는 최초 제출

2010년 8월 26일

처음 게시됨 (추정)

2010년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 6월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 6월 6일

마지막으로 확인됨

2019년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 113621

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD 공유 기간

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD 공유 액세스 기준

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

GSK580299(서바릭스)에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Peru

정황

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약물 개입

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스폰서 / 협력자

위치

구독하다