Immunogenicity, reactogenicity and safety study of two different formulations of GSK Biologicals’ human rotavirus vaccine, Rotarix, in healthy infants

Subjects’ parent(s)/ Legally Acceptable Representative (s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.

• Written informed consent obtained from the parent(s)/ LAR(s) of the subject prior to performing any study specific procedure.
• A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Birth weight >2000 grams.

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 vaccine (Day-29 to Day 1), or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) 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 any chronic drug therapy to be continued 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, according to the local immunization practice.
• 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.
• History of confirmed RV GE.
• Previous vaccination against RV.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, (including Severe Combined Immunodeficiency [SCID] disorder) based on medical history and physical examination.
• Uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
• History of IS.
• Very prematurely born infants (born ≤28 weeks of gestation).
• Hypersensitivity to latex.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment. This warrants deferral of vaccination.

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

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
• 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 (e.g., infliximab).
• GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).