To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Rotavirus Vaccines; Infections, Rotavirus

Treatments: Other: Data collection; Biological: Rotarix

Study type: Observational

Funder types: Industry

Identifiers

NCT00353366

2012-004039-21 (EudraCT Number)

103366

Details and patient eligibility

About

GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.

Full description

The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA.

Enrollment: 1,439 patients

Sex: All

Ages: 6 to 24 weeks 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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• A Filipino male or female aged at least 6 weeks at the time of the first 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.
• Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
• Any contraindications as stated in the Prescribing Information.

Trial design

1,439 participants in 1 patient group

Cohort Group

Description:

Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks

Treatment:

Other: Data collection

Biological: Rotarix