Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
研究概览
简要总结
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate study (see reference).
详细描述
All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/
- •Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
- •Healthy subjects as established by medical history and clinical examination.
- •Female subjects of non-childbearing potential may receive the booster vaccine.
- •Female subjects of childbearing potential may receive the booster vaccine, if the subject:
- •practices/has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •agrees to continue adequate contraception during the entire booster epoch.
排除标准
- •Exclusion criteria to be checked at study entry:
- •Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/
- •History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
- •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.
- •Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- •Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :
- •hypersensitivity reaction to any component of the vaccine,
- •encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
- •fever >= 40 °C (axillary temperature) 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 three days of vaccination.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Additional exclusion criteria to be checked for subjects before the booster vaccination administration:
- •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 dose.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active 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.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
结局指标
主要结局
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
时间窗: At Year 8.5
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
时间窗: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
时间窗: At Year 8.5
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
Concentrations for Anti-D and Anti-T Antibodies.
时间窗: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
时间窗: At 1 month post Year 10 booster vaccination
A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/\< 5 EL.U/mL.
Number of Seroprotected Subjects Against Diphtheria and Tetanus
时间窗: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
时间窗: At Year 10
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
时间窗: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
次要结局
- 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 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 Serious Adverse Events (SAEs).(From Year 8.5 up to study end (one month post Year 10 booster vaccination))