NCT00369824已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,330
- 试验地点
- 51
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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)
时间窗: Before and one month after vaccination with Boostrix
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
时间窗: Before and one month after vaccination with Boostrix
Concentrations given as Geometric Means Concentrations (GMCs)
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
时间窗: Before and one month after vaccination with Menactra
Titers given as Geometric Mean Titers (GMTs)
次要结局
- Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)(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))
- 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(Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12))
- Concentration of Anti-D and Anti-T Antibodies(Before and one month after vaccination with Boostrix)
- Number of Subjects Reporting Solicited Local Symptoms(During the 7-day period following each vaccination)
- Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response(One month after vaccination with Menactra)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(During the 30-day period following each vaccination)
- 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)(Before and one month after vaccination with Boostrix)
- Number of Subjects With Booster Response for Anti-D and Anti-T(One month after vaccination with Boostrix)
- Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN(One month after vaccination with Boostrix)
- Number of Subjects Reporting Solicited General Symptoms(During the 7-day period following each vaccination)
- Number of Subjects Reporting Serious Adverse Events(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))
- Number of Subjects Reporting Medically Significant Adverse Events (AEs)(During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13))
研究者
研究点 (51)
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