A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
研究概览
简要总结
The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.
One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.
The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.
The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.
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, 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
- •Subjects with a live twin living in the same household who is also enrolled in this study.
- •Born after a gestation period of ≥32 weeks,
- •Discharged from hospital neonatal care stay,
- •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 14 weeks of age at the time of the first study vaccination.
- •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 subjects.
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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Any clinically significant history of chronic gastrointestinal disease.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at time of enrolment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Contact with an immunosuppressed individual.
- •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).
- •Chronic administration of immunosuppressants since birth.
- •Gastroenteritis within 7 days preceding the first study vaccine administration.
- •Documented HIV-positive subject.
研究组 & 干预措施
Placebo Group
All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
干预措施: Placebo (Biological)
Placebo Group
All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
干预措施: Rotarix (Biological)
Rotarix Group
All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).
Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
干预措施: Rotarix (Biological)
结局指标
主要结局
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
时间窗: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
次要结局
- Duration of Human Rotavirus (HRV) Shedding Per Study Group.(From Day 0 up to Week 13.)
- Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.(During the entire study period (up to Visit 4, Week 17).)
- Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.(During the entire study period (up to Visit 4, Week 17).)
- Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.(At Visit 3 (Week 13).)
- Anti-rotavirus IgA Antibody Concentration.(At Visit 3 (Week 13).)
- Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.(Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs).(Within 31 days after any doses.)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs).(Up to Visit 4.)