- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00369824
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
A Randomized, Open Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine Co-administered Intramuscularly With Boostrix® and/or Menactra™ in Healthy Female Subjects Aged 11-18 Years
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/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alabama
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Mobile, Alabama, 미국, 36608
- GSK Investigational Site
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Arizona
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Chandler, Arizona, 미국, 85224
- GSK Investigational Site
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Mesa, Arizona, 미국, 85203
- GSK Investigational Site
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Arkansas
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Jonesboro, Arkansas, 미국, 72401
- GSK Investigational Site
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Little Rock, Arkansas, 미국, 72205
- GSK Investigational Site
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California
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Fountain Valley, California, 미국, 92708
- GSK Investigational Site
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Fresno, California, 미국, 93720
- GSK Investigational Site
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Long Beach, California, 미국, 90806
- GSK Investigational Site
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Madera, California, 미국, 93637
- GSK Investigational Site
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Rolling Hills Estates, California, 미국, 90274
- GSK Investigational Site
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Colorado
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Centennial, Colorado, 미국, 80112
- GSK Investigational Site
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Golden, Colorado, 미국, 80401
- GSK Investigational Site
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Thornton, Colorado, 미국, 80233
- GSK Investigational Site
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Florida
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Cocoa Beach, Florida, 미국, 32931
- GSK Investigational Site
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West Palm Beach, Florida, 미국, 33409
- GSK Investigational Site
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Georgia
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Marietta, Georgia, 미국, 30062
- GSK Investigational Site
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Kansas
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Arkansas City, Kansas, 미국, 67005
- GSK Investigational Site
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Lenexa, Kansas, 미국, 66219
- GSK Investigational Site
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Wichita, Kansas, 미국, 67207
- GSK Investigational Site
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Kentucky
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Bardstown, Kentucky, 미국, 40004
- GSK Investigational Site
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Lexington, Kentucky, 미국, 40503
- GSK Investigational Site
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Louisville, Kentucky, 미국, 40202
- GSK Investigational Site
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Louisiana
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Bossier City, Louisiana, 미국, 71111
- GSK Investigational Site
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Massachusetts
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Milford, Massachusetts, 미국, 01757
- GSK Investigational Site
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Michigan
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Niles, Michigan, 미국, 49120
- GSK Investigational Site
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Stevensville, Michigan, 미국, 49127
- GSK Investigational Site
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Nebraska
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Omaha, Nebraska, 미국, 68134
- GSK Investigational Site
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New Jersey
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Edison, New Jersey, 미국, 08817
- GSK Investigational Site
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Whitehouse Station, New Jersey, 미국, 08889
- GSK Investigational Site
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New Mexico
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Albuquerque, New Mexico, 미국, 87131
- GSK Investigational Site
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New York
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Rochester, New York, 미국, 14620
- GSK Investigational Site
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North Carolina
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Cary, North Carolina, 미국, 27518
- GSK Investigational Site
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Laurinburg, North Carolina, 미국, 28352
- GSK Investigational Site
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Raleigh, North Carolina, 미국, 27609
- GSK Investigational Site
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Sylva, North Carolina, 미국, 28779
- GSK Investigational Site
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Ohio
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Akron, Ohio, 미국, 44308
- GSK Investigational Site
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Boardman, Ohio, 미국, 44512
- GSK Investigational Site
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Cleveland, Ohio, 미국, 44118
- GSK Investigational Site
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Oregon
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Portland, Oregon, 미국, 97216
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, 미국, 16501
- GSK Investigational Site
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Greenville, Pennsylvania, 미국, 16125
- GSK Investigational Site
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Philadelphia, Pennsylvania, 미국, 19107
- GSK Investigational Site
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Pittsburgh, Pennsylvania, 미국, 15220
- GSK Investigational Site
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Uniontown, Pennsylvania, 미국, 15401
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, 미국, 29407
- GSK Investigational Site
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Charleston, South Carolina, 미국, 29401
- GSK Investigational Site
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Tennessee
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Gray, Tennessee, 미국, 37615
- GSK Investigational Site
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Texas
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San Angelo, Texas, 미국, 76904
- GSK Investigational Site
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Virginia
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Burke, Virginia, 미국, 22015
- GSK Investigational Site
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Vienna, Virginia, 미국, 22180
- GSK Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 11 and 18 years of age at the time of the first vaccination.
- Written informed consent obtained from parents/legally acceptable representative 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 is 18 years of age.
- Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
- Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time.
- Subjects must have a negative urine pregnancy test.
- Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions.
Exclusion Criteria:
- 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.
- Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product.
- 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. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- A woman 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
- Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years.
- Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years.
- Previous vaccination against Neisseria meningitidis.
- Hypersensitivity to latex.
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine.
- History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
- Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
- Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria- tetanu-pertussis (DTP) vaccine, not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine.
- Seizures with or without fever within three days of a prior dose of DTP vaccine.
- Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
- Previous history of Guillain-Barré syndrome.
- Any confirmed or suspected immunosuppressive or immunodeficient condition
- Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness
- 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.
공부 계획
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 |
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실험적: Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
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Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
One dose of vaccine administered intramuscularly
One dose of vaccine administered intramuscularly
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실험적: Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
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Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
One dose of vaccine administered intramuscularly
One dose of vaccine administered intramuscularly
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실험적: Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
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Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
One dose of vaccine administered intramuscularly
One dose of vaccine administered intramuscularly
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실험적: Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
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Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
One dose of vaccine administered intramuscularly
One dose of vaccine administered intramuscularly
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실험적: Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
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Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
One dose of vaccine administered intramuscularly
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실험적: Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
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Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
기간: Before and one month after vaccination with Boostrix
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Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
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Before and one month after vaccination with Boostrix
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Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
기간: Before and one month after vaccination with Boostrix
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Concentrations given as Geometric Means Concentrations (GMCs)
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Before and one month after vaccination with Boostrix
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Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
기간: Before and one month after vaccination with Menactra
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Titers given as Geometric Mean Titers (GMTs)
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Before and one month after vaccination with Menactra
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
기간: Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
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Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.
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Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
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Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
기간: Before and one month after vaccination with Boostrix
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Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)
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Before and one month after vaccination with Boostrix
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Concentration of Anti-D and Anti-T Antibodies
기간: Before and one month after vaccination with Boostrix
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Concentrations given as Geometric Mean Concentrations (GMCs)
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Before and one month after vaccination with Boostrix
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Number of Subjects With Booster Response for Anti-D and Anti-T
기간: One month after vaccination with Boostrix
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Booster responses for anti-D and anti-T defined as:
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One month after vaccination with Boostrix
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Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
기간: One month after vaccination with Boostrix
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Booster responses defined as:
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One month after vaccination with Boostrix
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Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
기간: One month after vaccination with Menactra
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Vaccine responses for anti-A, C, Y and W-135 defined as:
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One month after vaccination with Menactra
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Number of Subjects Reporting Solicited Local Symptoms
기간: During the 7-day period following each vaccination
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Solicited local symptoms assessed include pain, redness and swelling.
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During the 7-day period following each vaccination
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Number of Subjects Reporting Solicited General Symptoms
기간: During the 7-day period following each vaccination
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Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria
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During the 7-day period following each vaccination
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Number of Subjects Reporting Unsolicited Adverse Events (AEs)
기간: During the 30-day period following each vaccination
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Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study.
Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
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During the 30-day period following each vaccination
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Number of Subjects Reporting Serious Adverse Events
기간: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
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Serious adverse events assessed include medical occurrences that results in death, is 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.
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During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
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Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)
기간: During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
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NOCDs assessed include e.g.
autoimmune disorders, asthma, type I diabetes
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During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
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Number of Subjects Reporting Medically Significant Adverse Events (AEs)
기간: During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
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Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
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During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 107682
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
연구 데이터/문서
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개별 참가자 데이터 세트
정보 식별자: 107682정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 107682정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 107682정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 107682정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 107682정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 107682정보 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. .
Different formulations of GSK Biologicals' HPV vaccine (580299)에 대한 임상 시험
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GlaxoSmithKline완전한감염, 유두종 바이러스 | 유두종 바이러스 백신미국