NCT01107587已完成1 期
Reactogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine 444563, in Healthy Infants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Occurrence of grade 3 solicited adverse events.
研究概览
简要总结
The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 16 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 of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
- •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.
- •Born after a gestation period of 36 to 42 weeks inclusive.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccine 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 (for corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
- •Any clinically significant history of gastrointestinal disease including any 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.
- •A family history of congenital or hereditary immunodeficiency.
- •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 the time of enrolment..
- •History of confirmed rotavirus gastroenteritis.
- •Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
- •Previous vaccination with rotavirus vaccine or planned to use during the study period.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the 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.
结局指标
主要结局
Occurrence of grade 3 solicited adverse events.
时间窗: Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
次要结局
- Occurrence of each solicited adverse event.(Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.)
- Occurrence of serious adverse events.(Throughout the study period (Day 0 to Month 2).)
- Occurrence of unsolicited adverse events.(Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy AdultsPneumococcal DiseaseNCT01767402GlaxoSmithKline150
已完成
1 期
Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young AdultsStreptococcus PneumoniaeHaemophilus InfluenzaeNCT00814489GlaxoSmithKline40
已完成
2 期
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First VaccinationInfections, StreptococcalNCT00985751GlaxoSmithKline257
已完成
3 期
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in MaliInfections, StreptococcalNCT00985465GlaxoSmithKline218
已完成
3 期
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in NigeriaInfections, StreptococcalNCT01153893GlaxoSmithKline105