Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 985
- 试验地点
- 2
- 主要终点
- Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen
研究概览
简要总结
The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.
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
- 60 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
- •Born after a gestation period of 36 to 42 weeks, inclusive.
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent(s) or LAR(s) 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.
- •Child in care.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •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 hepatitis B 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.
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Haemophilus influenzae type b (Hib) disease or vaccination.
- •History of seizures or progressive neurological disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- •Current febrile illness or axillary temperature > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.
研究组 & 干预措施
INFANRIX-IPV+HIB 1 GROUP
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
干预措施: Infanrix-IPV/Hib™ (Biological)
INFANRIX-IPV+HIB 2 GROUP
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
干预措施: Infanrix-IPV/Hib™ (Biological)
INFANRIX-HIB+POLIORIX GROUP
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
干预措施: Infanrix Hib™ (Biological)
INFANRIX-HIB+POLIORIX GROUP
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
干预措施: Poliorix™ (Biological)
结局指标
主要结局
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen
时间窗: One month after the third vaccine dose (Month 3 or Month 4)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
时间窗: One month after the third vaccine dose (Month 3 or Month 4)
Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects \[antibody concentration lower than (\<) 5 EL.U/mL\], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
时间窗: One month after the third vaccine dose (Month 3 or Month 4)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens
时间窗: One month after the third vaccine dose (Month 3 or Month 4)
A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
次要结局
- Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses)
- Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses)
- Anti-D and Anti-T Antibody Concentrations(Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4))
- Anti-PRP Antibody Concentrations(Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4))
- Anti-polio Types 1, 2 and 3 Antibody Titers(Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4))
- Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4))
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period after any dose)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 to Month 4/5))