EUCTR2012-002426-70-Outside-EU/EEA进行中（未招募）不适用
Phase III b, open, randomised, multicenter study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-conjugated Haemophilus influenzae type b vaccine (Infanrix™ hexa) in Indian infants according to a 6-10-14 week schedule, when compared to Infanrix™ hexa given to Indian infants according to a 2-4-6 month schedule. - DTPA-HBV-IPV-106
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Born after a normal gestation period
- •Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/ immunisation certificate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 224
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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.
- •Chronic administration of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
- •Any chronic drug therapy to be continued during the study period.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
- •Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
- •Known immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
研究者
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