Safety Profile Following Pentabio Vaccination in Indonesian Infants

PT Bio Farma

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT02093286

PMS Penta 0414

Details and patient eligibility

About

To assess any serious systemic reaction within 30 minutes after Pentabio immunization

Full description

Any local and systemic reaction after Pentabio immunization

Enrollment: 4,000 patients

Sex: All

Ages: 2 to 11 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Immunization with Pentabio vaccine
• Parents already understood the consequences to be involved in this study and having signed the informed consent form
• Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization

Exclusion criteria

• Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.

Trial design

4,000 participants in 1 patient group

Pentabio Vaccine

Description:

1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly