NCT02096263已完成3 期
Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 585
- 试验地点
- 44
- 主要终点
- Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
研究概览
简要总结
The purpose of this study is to assess the 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.
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
- None
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' parent(s)/ Legally Acceptable Representative(s) (LARs) 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 (i.e. after a gestation period of 37 weeks to less than 42 completed weeks [259 to 293 days]).
- •Written informed consent obtained from parent(s)/LAR(s) 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.
排除标准
- •Child in care
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
- •Chronic administration (defined as more than 14 days in total) 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 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study:
- •Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
- •Routine administration(s) 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 before 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 (pharmaceutical product or device).
- •History of Hib, diphtheria, tetanus, pertussis, pneumococcal, 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 (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including yeast).
- •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 (SCID).
- •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 temperature in this study will be rectal for Epoch 001 and axillary for Epoch
- •Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
结局指标
主要结局
Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
时间窗: At Month 5, one month after the third dose of the primary vaccination.
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
次要结局
- Number of Seroprotected Subjects Against Tetanus (T).(At Month 5, one month after the third dose of the primary vaccination.)
- Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
- Antibody Concentrations for Anti-T.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
- Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)])
- Antibody Concentrations for Anti-HBs.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
- Number of Subjects With Specific Adverse Events (AEs).(From Month 0 up to 6 months post primary-vaccination (Month 10))
- Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.(At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)])
- Number of Subjects With Specific AEs.(During the 31-day (Days 0-30) post-booster vaccination.)
- Number of Seroprotected Subjects Against Diphtheria (D).(At Month 5, one month after the third dose of the primary vaccination.)
- Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).(At Month 5, one month after the third dose of the primary vaccination)
- Number of Subjects With Solicited Local Symptoms.(During the 4-day (Days 0-3) post-booster vaccination.)
- Number of Subjects With Unsolicited AEs.(During the 31-day (Days 0-30) post-booster vaccination.)
- Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.(At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
- Number of Seroprotected Subjects Against Anti-PRP.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)])
- Antibody Titres for Anti-polio Types 1, 2 and 3.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
- Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.(At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)])
- Antibody Concentrations for Anti-D.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
- Antibody Concentrations for Anti-PRP.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)])
- Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).(At Month 5, one month after the third dose of the primary vaccination)
- Number of Subjects With Serious Adverse Events (SAEs).(From Month 0 up to 6 months post-primary vaccination (Month 10))
- Number of Seroprotected Subjects Against Anti-D.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)])
- Number of Subjects With Solicited General Symptoms.(During the 4-day (Days 0-3) post-booster vaccination.)
- Number of Seroprotected Subjects Against Anti-T.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)])
- Number of Seroprotected Subjects Against Anti-HBs.(At Visit 5 [At Month 13-16 before the booster dose (Dose 4)])
- Number of Subjects With SAEs.(During the 31-day (Days 0-30) post-booster vaccination.)
研究者
研究点 (44)
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