Study to evaluate the safety of Rotarix™ in Chinese childre
- Conditions
- Rotavirus gastroenteritisTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-001547-37-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 50
-Subjects who the investigator believes that their parents/guardians (Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
-A male or female subject of Chinese origin, between, and including, 2 and 6 years of age at the time of vaccination.
-Written informed consent obtained from the parent or legally acceptable representative of the subject.
-Healthy subjects as established by medical history and clinical examination before entering into the stud
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the study vaccine, or planned use during the study period.
-Chronic administration of immunosuppressants or other immune-modifying drugs six months prior to the vaccine dose.
-Planned administration/administration of a vaccine not foreseen by the study protocol within 14 days of the Human Rotavirus vaccine or placebo with the exception of the routine childhood vaccines. Routine childhood vaccines must not be administered on the same day as the Human Rotavirus vaccine or placebo.
-Administration of immunoglobulins and/or any blood products since birth within three months preceding the study vaccine or planned administration during the study period.
-Major congenital defects or serious chronic illness.
-Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-History of Intusussception or any chronic gastrointestinal disease that would predispose for Intusussception including any uncorrected congenital malformation of the gastrointestinal tract.
-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
-Acute disease at the time of enrolment.
-Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
-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..
-Child in care.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the reactogenicity of a single oral dose of GSK Biologicals’ liquid HRV vaccine when compared to placebo group, in terms of solicited AEs in healthy children aged 2 to 6 years;Secondary Objective: To assess the safety of a single oral dose of GSK Biologicals’ liquid HRV vaccine when compared to placebo group, in terms of unsolicited AEs and serious adverse events (SAEs) in healthy children aged 2 to 6 years;Primary end point(s): Occurrence of each solicited symptom ;Timepoint(s) of evaluation of this end point: Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Unsolicited AE: Within the 31 days (Day 0 - Day 30) after the vaccine dose, SAEs: Throughout the study period following the vaccine dose.<br><br>;Secondary end point(s): Occurrence of unsolicited adverse events <br>Occurrence of serious adverse events