이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

2018년 6월 28일 업데이트: GlaxoSmithKline

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.

연구 개요

연구 유형

중재적

등록 (실제)

814

단계

  • 3단계

연락처 및 위치

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

연구 장소

      • Hoersholm, 덴마크, 2970
        • GSK Investigational Site
      • Odense C, 덴마크, 5000
        • GSK Investigational Site
      • Karlskrona, 스웨덴, SE-371 41
        • GSK Investigational Site
      • Linköping, 스웨덴, SE-581 85
        • GSK Investigational Site
      • Lycksele, 스웨덴, SE-921 82
        • GSK Investigational Site
      • Umeå, 스웨덴, SE-901 85
        • GSK Investigational Site
      • Örebro, 스웨덴, SE-702 11
        • GSK Investigational Site
    • British Columbia
      • Surrey, British Columbia, 캐나다, V3R 8P8
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, 캐나다, L6T 3T1
        • GSK Investigational Site
      • Newmarket, Ontario, 캐나다, L3Y 5G8
        • GSK Investigational Site
      • Sarnia, Ontario, 캐나다, N7T 4X3
        • GSK Investigational Site
      • Sudbury, Ontario, 캐나다, P3E 1H5
        • GSK Investigational Site
      • Bordány, 헝가리, 6795
        • GSK Investigational Site
      • Budapest, 헝가리, 1032
        • GSK Investigational Site
      • Budapest, 헝가리, 1033
        • GSK Investigational Site
      • Budapest, 헝가리, 1039
        • GSK Investigational Site
      • Budapest, 헝가리, 1089
        • GSK Investigational Site
      • Győr, 헝가리, 9024
        • GSK Investigational Site
      • Hódmezővásárhely, 헝가리, 6800
        • GSK Investigational Site
      • Szeged, 헝가리, 6723
        • GSK Investigational Site
      • Szombathely, 헝가리, 9700
        • 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

9년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's LAR, and written informed assent must be obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects must not be pregnant.
  • Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
  • Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • 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 each dose of vaccine(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
  • 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 women.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
  • Previous administration of components of the investigational vaccine.
  • Previous vaccination against hepatitis A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
  • History of hepatitis A or B infection.
  • Known exposure to hepatitis A or B within the previous 6 weeks.
  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
  • Cancer or autoimmune disease under treatment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
  • 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.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Cervarix™ & Twinrix™ Group
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
다른 이름들:
  • HPV 백신
  • GSK Biologicals' HPV-16/18 L1 AS04
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
실험적: Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
다른 이름들:
  • HPV 백신
  • GSK Biologicals' HPV-16/18 L1 AS04
활성 비교기: Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies
기간: At Month 7
Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
At Month 7
Anti-Heptatis A (HAV) Antibody Titers.
기간: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
At Month 7
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
기간: At Month 7
A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
At Month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
기간: At Month 7
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 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
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
기간: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
At Month 7

2차 결과 측정

결과 측정
측정값 설명
기간
Anti-HBs Antibody Titers
기간: At Month 7
Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.
At Month 7
Number of Subjects Seroconverted for Anti-HBs Antibodies
기간: At month 7
Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
At month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
기간: At Month 7
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 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
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
기간: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
At Month 7
Number of Subjects Seroconverted for Anti-HAV Antibodies
기간: One month after the second dose of vaccine
Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
One month after the second dose of vaccine
Anti-HAV Antibody Titers
기간: One month after the second dose of vaccine
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
One month after the second dose of vaccine
Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies
기간: One month after the second dose of vaccine

Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.

A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.

One month after the second dose of vaccine
Anti-HBs Antibody Titers
기간: One month after the second dose of vaccine
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
One month after the second dose of vaccine
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
기간: One month after the second dose of vaccine
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 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.
One month after the second dose of vaccine
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
기간: One month after the second dose of vaccine
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
One month after the second dose of vaccine
Number of Subjects Reporting Solicited Local Symptoms
기간: During the 7-day period (Day 0-6) following vaccination
Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
During the 7-day period (Day 0-6) following vaccination
Number of Subjects Reporting Solicited General Symptoms
기간: During the 7-day period following vaccination
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.
During the 7-day period following vaccination
Number of Subjects Reporting Medically Significant Conditions
기간: Throughout the active phase of the study (up to Month 7)
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or 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, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Throughout the active phase of the study (up to Month 7)
Number of Subjects Reporting Medically Significant Conditions
기간: Throughout the safety follow-up (from Month 7 up to Month 12)
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or 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, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Throughout the safety follow-up (from Month 7 up to Month 12)
Number of Subjects Reporting Unsolicited Adverse Events
기간: During the 30-day period following any vaccination
Unsolicited adverse events include any adverse event 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.
During the 30-day period following any vaccination
Number of Subjects Reporting Serious Adverse Events (SAE)
기간: Throughout the study (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.
Throughout the study (up to Month 12)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2007년 12월 15일

기본 완료 (실제)

2008년 12월 1일

연구 완료 (실제)

2009년 4월 28일

연구 등록 날짜

최초 제출

2007년 12월 20일

QC 기준을 충족하는 최초 제출

2007년 12월 20일

처음 게시됨 (추정)

2007년 12월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 6월 28일

마지막으로 확인됨

2016년 10월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

연구 데이터/문서

  1. 주석이 달린 사례 보고서 양식
    정보 식별자: 110886
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 정보에 입각한 동의서
    정보 식별자: 110886
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 통계 분석 계획
    정보 식별자: 110886
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 데이터 세트 사양
    정보 식별자: 110886
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 연구 프로토콜
    정보 식별자: 110886
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 개별 참가자 데이터 세트
    정보 식별자: 110886
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 임상 연구 보고서
    정보 식별자: 110886
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register

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. .

Cervarix™에 대한 임상 시험

3
구독하다