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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Rotavirus

Treatments: Biological: Rotarix™

Study type: Observational

Funder types: Industry

Identifiers

NCT00938327

112896

Details and patient eligibility

About

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.

Enrollment: 332 patients

Sex: All

Ages: 6 weeks to 167 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

332 participants in 1 patient group

Rotarix Group

Description:

Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.

Treatment:

Biological: Rotarix™