Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,079
- 试验地点
- 1
- 主要终点
- Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes can and will comply with the requirements of the protocol and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol.
- •A female between, and including, 9 and 14 years of age at the time of the first vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, if capable, the subject should sign and personally date a written informed assent.
- •Healthy subjects 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 two months after completion of the vaccination series.
排除标准
- •Pregnant or breastfeeding.
- •A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
- •Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than those foreseen in the protocol.
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 36).
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
- •Cancer or autoimmune disease under treatment.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine. 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 is allowed. 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 (pharmaceutical product or device).
- •Previous administration of vaccine components.
- •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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
- •Acute disease and/or fever at the time of enrolment.
- •Drug and/or alcohol abuse.
研究组 & 干预措施
Cervarix 2 dose Group
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
干预措施: Cervarix (Biological)
Cervarix 2 dose Group
Subjects who received 2 doses of Cervarix vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
干预措施: Placebo (Drug)
Gardasil 2 dose Group
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
干预措施: Gardasil (Biological)
Gardasil 2 dose Group
Subjects who received 2 doses of Gardasil vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
干预措施: Placebo (Drug)
Gardasil 3 dose Group
Subjects who received 3 doses of Gardasil vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
干预措施: Gardasil (Biological)
结局指标
主要结局
Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity
时间窗: At Month 7 (i.e. one month after the last dose of study vaccine)
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity
时间窗: At Month 7 (i.e. one month after the last dose of study vaccine)
Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)
时间窗: At Month 7 (i.e. one month after the last dose of study vaccine)
Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses)
- Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC(At Day 0 and Months 7, 12, 18, 24 and 36)
- Anti-HPV-16/18 Antibody Titers as Assessed by ELISA(At Day 0 and Months 12, 18, 24 and 36)
- Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity(At Day 0 and Months 7, 12, 18, 24 and 36)
- Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity(At Day 0 and Months 7, 12, 18, 24 and 36)
- Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA(At Day 0 and Months 12, 18, 24 and 36)
- Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36(At Month 36)
- Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC(At Day 0 and Months 7, 12, 18, 24 and 36)
- T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)(At Day 0 and Months 7, 12, 24 and 36)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period)
- Number of Subjects Completing the Vaccination Schedule(From Day 0 up to Month 36 (throughout the study period))
- B-cell-mediated Immune Responses in the Sub-cohort for CMI(At Day 0 and Months 7, 12, 24 and 36)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses)
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 up to Month 36 (throughout the study period))
- Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies(From Day 0 up to Month 36 (throughout the study period))
- Number of Subjects Using a Concomitant Medication Throughout the Study Period(From Day 0 up to Month 36 (throughout the study period) following vaccination after each dose and across doses)
- Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)(From Day 0 up to Month 12)
- Number of Subjects With Medically Significant Conditions (MSCs)(From Day 0 up to Month 36 (throughout the study period))
- Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE(From Day 0 up to Month 36 (throughout the study period))