Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants
Phase 1
Completed
- Conditions
- Infections, Rotavirus
- Interventions
- Biological: GSK Biologicals' human rotavirus vaccine 444563Biological: Placebo
- Registration Number
- NCT01107587
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HRV group GSK Biologicals' human rotavirus vaccine 444563 Subjects will receive GSK Biologicals' human rotavirus vaccine 444563. Placebo Group Placebo Subjects will receive placebo.
- Primary Outcome Measures
Name Time Method Occurrence of grade 3 solicited adverse events. Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇳Liucheng County, Guangxi, China