Evaluation of GSK Biologicals' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 16
- 主要终点
- Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
研究概览
简要总结
This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.
详细描述
This protocol posting has been updated following protocol amendment 1, dated 03 June 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •Male or female subjects who have received vaccine in study NCT
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study and 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
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT
- •In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Group C.
- •History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
- •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 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.
- •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.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究组 & 干预措施
BOOSTRIX POLIO GROUP
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
干预措施: BoostrixTM Polio (Biological)
BOOSTRIX+POLIORIX GROUP
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
干预措施: BoostrixTM Polio (Biological)
REVAXIS GROUP
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
干预措施: BoostrixTM Polio (Biological)
结局指标
主要结局
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
时间窗: At Day 0
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
时间窗: At Day 0
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
时间窗: At Day 0
Titers are presented as geometric mean titers (GMTs).
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
时间窗: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
时间窗: At Day 0
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
时间窗: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
次要结局
- Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off(At Month 1)
- Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations(At Month 1)
- Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations(At Month 1)
- Number of Subjects With Any Unsolicited Adverse Events (AEs).(During the 31-day (Day 0-Day 30) follow-up period after vaccination)
- Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers(At Month 1)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0-Day 3) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day (Day 0-Day 3) follow-up period after vaccination)
- Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)(At Month 1)
- Number of Subjects With Serious Adverse Events (SAEs).(Month 0 - Month 1)