A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2-AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,960
- 试验地点
- 153
- 主要终点
- Number of Subjects With Serious Adverse Events (SAEs)
研究概览
简要总结
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Three groups of females (3000, 1500 and 1500 subjects, respectively) were injected 3 times (at months 0, 1 and 6) with the herpes simplex vaccine, the HavrixTM vaccine (control) and a Saline solution (placebo), respectively. Subjects were followed over 18 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
- •Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
- •Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
- •Subjects must have a negative urine pregnancy test.
- •Subjects of childbearing potential at the time of study entry must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Pregnant or lactating female.
- •Female planning to become pregnant or likely to become pregnant during the first eight months of the study (months 0-8).
- •Any previous confirmed history of, or current clinical signs or symptoms of, oro labial herpes (cold sores), herpetic whitlow or genital herpes disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, dysuria or pain, burning, itching, tingling in the ano-genital area.
- •History of previous or planned vaccination against hepatitis A or a history of hepatitis A infection.
- •Previous vaccination against herpes.
- •History of herpetic keratitis.
- •History of multiform erythema.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study vaccine with the following exceptions: administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before and 30 days after the first dose of study vaccine.
- •History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •History of a current acute or chronic autoimmune disease.
- •History of any neurological disorders or seizures, with the exception of a single febrile seizure during childhood.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- •Acute disease at the time of enrolment
- •Oral temperature >= 37.5°C (99.5°F) / axillary temperature >= 37.5°C (99.5°F) at the time of enrolment.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •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.
研究组 & 干预措施
GD2-AS04 GROUP
Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
干预措施: GSK208141 (Biological)
HAVRIX GROUP
Female subjects aged 10-17 years, who received 3 doses of Havrix, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
干预措施: Havrix (investigational formulation) (Biological)
SALINE GROUP
Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: From Month 0 to Month 12
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 7 days (Days 0-6) after each and any vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 7 days (Days 0-6) after each and any vaccination)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Day 0-29) after any vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Up to month 18 (during active phase and ESFU period))
- Number of Subjects With New Onset Chronic Diseases (NOCD)(During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18))
- Number of Subjects With Medically Significant Conditions (MSC)(During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18))
- Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits(Starting from Day 30 until the end of study (Month 18))
- Anti-glycoprotein D (Anti-gD) Antibody Concentrations(At months 0, 7 and 12)
- Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations(At months 0, 7 and 12)
- Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed(At months 7 and 12)