Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent 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
- 4,021
- 试验地点
- 58
- 主要终点
- Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
研究概览
简要总结
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.
The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.
All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.
Note: This protocol posting deals with the objectives & outcome measures for the booster phase of the study. The objectives & outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)
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 (Care Provider)
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
排除标准
- •Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
- •History of measles, mumps, rubella or varicella.
- •Previous vaccination against measles, mumps, rubella or varicella.
- •Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- •Patients receiving immunosuppressive therapy.
- •Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- •Individuals with primary and acquired immunodeficiency states.
- •Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- •Individuals with active tuberculosis.
- •Acute disease at time of booster vaccination
结局指标
主要结局
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
时间窗: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits
时间窗: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of Subjects Reporting Serious Adverse Events (SAEs)
时间窗: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
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 Reporting Rash
时间窗: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
时间窗: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
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 New Onset of Chronic Illnesses (NOCIs)
时间窗: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Rash
时间窗: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
次要结局
未报告次要终点