NCT02858440已完成3 期
Immunogenicity and Safety of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus and Haemophilus Influenzae Type b (DTPa-IPV/Hib) Conjugate Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 6
- 主要终点
- Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination
研究概览
简要总结
The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 19 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects' parent(s)/Legally Acceptable Representatives [LARs] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •A male or female child between 3 and 4 months of age at the time of the first vaccination.
- •Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born full-term.
排除标准
- •Child in care
- •Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Administration of long-acting immune-modifying drugs at any time during the study period
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of hepatitis B and other vaccines given as part of the national immunisation schedule and as part of routine vaccination practice, that are allowed at any time during the study period. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
- •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 vaccine/product
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
- •History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.
- •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 vaccine.
- •Major congenital defects.
- •Serious chronic illness.
- •History of any neurological disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥38.0°C for rectal route.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
结局指标
主要结局
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination
时间窗: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.
Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination
时间窗: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination
时间窗: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination
时间窗: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.
次要结局
- Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination(At Month 4 (i.e. one month after 3rd dose of primary vaccination))
- Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination(During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3))
- Number of Subjects With Any Solicited General AEs Following Booster Vaccination(During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15))
- Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination(During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3))
- Number of Subjects With Any Solicited Local AEs Following Booster Vaccination(During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15))
- Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination(During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3))
- Number of Subjects With Unsolicited AEs Following Booster Vaccination(During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15))
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (i.e. from Day 0 until Month 16))
- Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
- Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
- Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination(At Month 4 (i.e. one month after 3rd dose of primary vaccination))
- Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
- Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
- Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination(At Month 4 (i.e. one month after 3rd dose of primary vaccination))
- Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
- Antibody Concentration for Anti-PRP, Post Primary Vaccination(At Month 4 (i.e. one month after 3rd dose of primary vaccination))
- Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
- Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
- Antibody Concentration for Anti-PRP, Post Booster Vaccination(At Month 16 (i.e. one month after booster vaccination))
研究者
研究点 (6)
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