NCT00480324已完成3 期
Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 765
- 试验地点
- 21
- 主要终点
- Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
研究概览
简要总结
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.
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 14 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
- •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
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Born between a gestation period of 36 and 42 weeks inclusive.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- •History of use of experimental rotavirus vaccine.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- •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 (pharmaceutical product or device).
- •Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Previous confirmed occurrence of RV GE.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- •A family history of congenital or hereditary immunodeficiency.
- •Acute disease at the time of enrolment.
- •Gastroenteritis within 7 days preceding the study vaccine administration.
- •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
Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
时间窗: From 2 weeks after Dose 2 up to 2 years of age
Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
次要结局
- Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains(From Dose 1 up to 2 years of age)
- Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types(From 2 weeks after Dose 2 up to 2 years of age)
- Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains(From 2 weeks after Dose 2 up to 2 years of age)
- Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type(From 2 weeks after Dose 2 up to 2 years of age)
- Number of Subjects Reporting Solicited Symptoms(During the 8-day follow-up period after each dose)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Up to 2 years of age)
- Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains(From 2 weeks after Dose 2 up to 2 years of age)
- Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration(2 months after Dose 2)
- Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies(2 months after Dose 2)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(During the 31-day follow-up period after each dose)
研究者
研究点 (21)
Loading locations...
相似试验
招募中
不适用
Biomarker study of immunological response in Japanese patients with stage III non-small cell lung cancer receiving chemoradiotherapy followed by durvalumabon-small cell lung cancerJPRN-UMIN000039167Wakayama Medical University150
已完成
3 期
Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00318786Novo Nordisk A/S289
已完成
1 期
A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of RisankizumabHealthy VolunteersNCT05305222AbbVie17
已完成
不适用
A study about immunogenicity and safety of an additional varicella vaccinatiovaricellaJPRN-UMIN000009888Konan Kosei Hospital30
已完成
3 期
Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and OlderInfluenzaNCT00979602GlaxoSmithKline4,048