A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,432
- 试验地点
- 64
- 主要终点
- Number of Subjects Reporting Rash
研究概览
简要总结
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.
This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
详细描述
Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after 36 weeks gestation.
- •Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
- •Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.
- •Exclusion criteria:
- •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.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- •Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- •In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
- •History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Concurrent participation 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).
排除标准
- 未提供
结局指标
主要结局
Number of Subjects Reporting Rash
时间窗: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)
时间窗: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
时间窗: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
时间窗: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects Reporting Serious Adverse Events (SAEs)
时间窗: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects With Rash
时间窗: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Number of Subjects With Adverse Events Resulting in Emergency Room (ER)
时间窗: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
次要结局
未报告次要终点