Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants

Post Marketing Surveillance to Monitor the Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered According to the Prescribing Information to Indian Infants

This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.
• A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination.
• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Acute disease at the time of enrolment.
• Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception.
• Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
• Gastroenteritis within 7 days preceding vaccination.