NCT00757770已完成3 期
Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 854
- 试验地点
- 4
- 主要终点
- Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
研究概览
简要总结
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 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 parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems 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 (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Child is unlikely to remain in the study area for the duration of the study.
- •Previous confirmed occurrence of rotavirus gastroenteritis.
- •Gastroenteritis within 7 days preceding the study vaccine administration.
- •Household contact with an immunosuppressed individual or pregnant woman.
- •Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
- •Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
结局指标
主要结局
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
时间窗: Two months after Dose 2.
次要结局
- Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.(Two months after Dose 1.)
- Presence of rotavirus in stool samples in a subset of subjects(On the day of each vaccination and on planned days following each vaccination.)
- Seroconversion rates to anti-rotavirus IgA antibody(Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).)
- For each type of solicited symptom, occurrence of the symptom(During the 8-day follow-up period after each vaccine dose)
- Vaccine take rates in a subset of subjects.(Two months after each dose)
- Occurrence of unsolicited symptoms(During the 31-day follow-up period after each vaccine dose.)
- Occurrence of serious adverse events(Throughout the study period.)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV VaccinesAcellular PertussisDiphtheriaTetanusNCT00148941GlaxoSmithKline4,209
已完成
3 期
A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority StudyInfections, StreptococcalNCT00307554GlaxoSmithKline1,600
已完成
3 期
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).Infections, RotavirusNCT00382772GlaxoSmithKline1,200
已完成
3 期
VELOCITY: An Anthrax Vaccine Clinical StudyAnthraxNCT03877926Emergent BioSolutions3,689
已完成
3 期
Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in AdultsOrthomyxoviridae InfectionMyxovirus InfectionInfluenzaNCT00772109Sanofi Pasteur, a Sanofi Company4,292