EUCTR2013-004304-19-Outside-EU/EEA进行中（未招募）不适用
A Phase III, randomized, open-label, controlled, multicenter study to evaluate immunogenicity and safety of GSK Biologicals' Infanrix hexa™ vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar® and Rotarix™ with a booster dose of GSK Biologicals’ Infanrix® and Hiberix™ vaccines at 15-18 months of age. - DTPA-HBV-IPV-135
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
- 585
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’ parents/ Legally Acceptable Representatives who, in the opinion of the investigator, 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.
- •Born full-term.
- •Written informed consent obtained from parents/LARs of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 585
- •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
- •Child in care
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 and from 30 days before the booster Dose 4 until 30 days after booster Dose 4.
- •Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
- •Routine administrations of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days be-fore booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US.
- •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.
- •History of Hib, diphtheria, tetanus, pertussis, pneumo-coccal, rotavirus, poliovirus and hepatitis B diseases.
- •Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Hypersensitivity to latex.
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders including seizures.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
- •History of Severe Combined Immunodeficiency Disease.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature = 38.0°C /100.4°F by any route. The preferred route for recording tempera-ture in this study will be rectal for Epoch 001 and axillary for Epoch 002.
- •Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
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