Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 387
- 试验地点
- 14
- 主要终点
- Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens
研究概览
简要总结
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.
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
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).
- •Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).
- •Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine.
- •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.
- •Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.
- •Previous measles, mumps and/or rubella second dose vaccination.
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.
- •Known exposure to measles, mumps and/or rubella within 30 days prior to study start.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation.
- •Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:
- •Hypersensitivity reaction to any component of the vaccine;
- •Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;
- •Fever >= 40°C within 48 hours of vaccination, not due to another identifiable cause;
- •Collapse or shock-like state within 48 hours of vaccination;
- •Convulsions with or without fever, occurring within 3 days of vaccination.
- •Acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.
研究组 & 干预措施
BOOSTRIX POLIO GROUP
Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
干预措施: Boostrix PolioTM (Biological)
BOOSTRIX POLIO GROUP
Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
干预措施: PriorixTM (Biological)
REPEVAX GROUP
Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
干预措施: RepevaxTM (Biological)
REPEVAX GROUP
Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
干预措施: PriorixTM (Biological)
结局指标
主要结局
Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens
时间窗: At Month 1, one month after the booster vaccination
Booster response was defined as: For initially seronegative subjects \[i.e. pre-vaccination concentration below (\<) cut-off value of 0.1 international units per milliliter (IU/mL)\] antibody concentrations at least four times the assay cut-off \[post vaccination concentration greater than or equal to (≥) 0.4 IU/ml\]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
时间窗: At Month 1, one month after the booster vaccination
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Anti-Polio Virus Type 1, 2 and 3 Antibody Titers
时间窗: At Month 1, one month after the booster vaccination
Antibody titers were presented as geometric mean titers (GMTs).
次要结局
- Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seroprotected Subjects Against Polio Type 1, 2 and 3(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seropositive Subjects for Anti-mumps Antibody(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seropositive Subjects for Anti-rubella Antibody(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seropositive Subjects for Anti-measles Antibody(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-D and Anti-T Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(At Month 0, before the booster vaccination)
- Anti-mumps Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-measles Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-rubella Antibody Concentrations(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Anti-Polio Type 1, 2 and 3 Antibody Titers(At Month 0, before the booster vaccination)
- Number of Subjects With a Booster Response to PT, FHA and PRN Antigens(At Month 1, one month after the booster vaccination)
- Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens(At Month 1, one month after the booster vaccination)
- Number of Seroconverted Subjects for Anti-measles(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Seroconverted Subjects for Anti-mumps(Before (Month 0) and one month after (Month 1) the booster vaccination)
- Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) follow-up period after booster vaccination)
- Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) follow-up period after booster vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) follow-up period after booster vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (From Day 0 to Month 1))