Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Child in care

Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period.

Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.

Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Administration of long-acting immune-modifying drugs at any time during the study period.

Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.

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 vaccine/product.

Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).

History of IS.

Family history of congenital or hereditary immunodeficiency.

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Major congenital defects or serious chronic illness.

Previous vaccination against RV.

Previous confirmed occurrence of RVGE.

GE within 7 days preceding the study vaccine administration.

History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

Hypersensitivity to latex.

Acute disease and/or fever at the time of enrolment.

* Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.

* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

What this study is about