NCT01090453已完成2 期
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 35
- 主要终点
- Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
研究概览
简要总结
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 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
- 8 Weeks 至 12 Weeks（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) can and will comply with the requirements of the protocol.
- •A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •Written informed consent obtained from the parent(s), Legally Acceptable Representative(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.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- •Child in care.
- •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 randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit
- •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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth.
- •History of seizures or progressive neurological disease.
- •Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- •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 if no other exclusion criteria is met:
- •Current febrile illness or other moderate to severe illness within 24 hours of study vaccine administration.
- •Current gastrointestinal infection.
结局指标
主要结局
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
时间窗: At Month 3
The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off
时间窗: At Month 3
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
次要结局
- Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-PRP.(At Month 3, Month 10 and Month 11.)
- Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.(At Month 3, Month 10 and Month 11.)
- Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-PT, Anti-FHA and Anti-PRN.(At Month 3, Month 10 and Month 11.)
- Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.(At Month 11.)
- Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.(At Month 3 and Month 11)
- Number of Subjects Reporting Any Solicited General Symptoms.(During the 8-day (Days 0-7) post-vaccination period)
- Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)(At Month 3, Month 10 and Month 11.)
- Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.(At Month 11.)
- Number of Subjects Reporting Any Solicited Local Symptoms.(During the 8-day (Days 0-7) post-vaccination period)
- Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs(At Month 3, Month 10 and Month 11.)
- Titers for rSBA-MenC.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-T and Anti-D.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-HBs.(At Month 3, Month 10 and Month 11.)
- Titers for Anti-polio 1, 2 and 3.(At Month 3, Month 10 and Month 11.)
- Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-PNE Serotypes.(At Month 3 and Month 11)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).(Within the 31-day (Days 0-30) follow up period after vaccination)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs).(During the entire study period (Month 0 to Month 11))
研究者
研究点 (35)
Loading locations...
相似试验
终止
2 期
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.PoliomyelitisNeisseria MeningitidisHaemophilus Influenzae Type bAcellular PertussisHepatitis BTetanusDiphtheriaNCT00871741GlaxoSmithKline16
已完成
2 期
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of AgeHaemophilus Influenzae Type bPoliomyelitisAcellular PertussisDiphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria MeniDiphtheriaHepatitis BTetanusNCT00970307GlaxoSmithKline421
已完成
2 期
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster DoseHaemophilus Influenzae Type bPoliomyelitisAcellular PertussisDiphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria MeniHepatitis BDiphtheriaTetanusNCT01171989GlaxoSmithKline391
已完成
2 期
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive AdultsTuberculosisNCT01262976GlaxoSmithKline240
已完成
3 期
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in ChildrenInfluenzaNCT01196988GlaxoSmithKline3,027