Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Rotavirus

Treatments: Biological: Rotarix or Rotarix liquid formulation

Study type: Observational

Funder types: Industry

Identifiers

NCT00750893

111700

Details and patient eligibility

About

This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.

Full description

The protocol posting has been amended to reflect the two new vaccine presentations that have been launched in Korea. The current PMS will thus collect safety information from subjects who have received either Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) in the course of their routine clinical practice according to the prescribing information in Korea.

Enrollment: 3,111 patients

Sex: All

Ages: 6 to 24 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.

Trial design

3,111 participants in 1 patient group

Rotarix Group

Description:

Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.

Treatment:

Biological: Rotarix or Rotarix liquid formulation