Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 8
- 主要终点
- Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
研究概览
简要总结
This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy.
In this study, MMRV vaccine will also be co-administered to all 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
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female child of 5 and 6 years of age at the time of vaccination.
- •Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy.
- •Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy.
- •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.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine(s) 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 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.
- •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 tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life.
- •Previous measles, mumps, rubella and/or varicella second dose vaccination.
- •Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease.
- •Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Administration of immunoglobulin and/or any blood products within the three months preceding vaccination or planned administration during the study period.
- •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- •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.
- •Residence in the same household as a person high risk for varicella
- •The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- •Current febrile illness or axillary temperature ≥ 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
研究组 & 干预措施
BOOSTRIX POLIO GROUP
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
干预措施: Boostrix Polio™ 711866 (Biological)
BOOSTRIX POLIO GROUP
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
干预措施: Priorix Tetra TM 208136 (Biological)
TETRAVAC GROUP
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
干预措施: Priorix Tetra TM 208136 (Biological)
TETRAVAC GROUP
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
干预措施: Tetravac TM (Biological)
结局指标
主要结局
Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
时间窗: At Month 1, one month post-vaccination
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Number of Seroprotected Subjects Against Polio Types 1, 2 and 3
时间窗: At Month 1, one month post-vaccination
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.
Number of Seropositive Subjects for Anti-D and Anti-T Antibodies
时间窗: At Month 1, one month post-vaccination
A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).
Anti-poliovirus Types 1, 2 and 3 Antibody Titres
时间窗: At Month 1, one month post-vaccination
Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.
次要结局
- Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens(At Month 1, one month post-vaccination)
- Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations(At Month 1, one month post-vaccination)
- Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies(At Month 1, one month post-vaccination)
- Anti-measles and Anti-varicella Antibody Concentrations(At Month 1, one month post-vaccination)
- Anti-rubella Antibody Concentrations(At Month 1, one month post-vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(During the whole study period (from Month 0 to Month 1))
- Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella(At Month 1, one month post-vaccination)
- Anti-mumps Antibody Concentrations(At Month 1, one month post-vaccination)
- Number of Subjects With Booster Responses to Anti-D and Anti-T(At Month 1, one month post-vaccination)
- Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3(At Month 1, one month post-vaccination)
- Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN(At Month 1, one month post-vaccination)
- Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella(At Month 1, one month post-vaccination)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period)