Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

Novartis

Status: Completed

Conditions: Pandemic Influenza A (H1N1); A New Flu Virus of Swine Origin

Treatments: Other: Non-intervention observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT01040741

V111_09OB

Details and patient eligibility

About

This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses.

Enrollment: 7,284 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject's age in accordance with the approved product label of the country where the study is conducted
• Subjects will be vaccinated with Focetria®, independently of this study.
• Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Exclusion criteria

• Received any prior H1N1 vaccination

Trial design

7,284 participants in 6 patient groups

Group 1: 6-23 months

Treatment:

Other: Non-intervention observational study

Group 2: 2-8 years

Treatment:

Other: Non-intervention observational study

Group 3: 9-17 years

Treatment:

Other: Non-intervention observational study

Group 4: 18-44 years

Treatment:

Other: Non-intervention observational study

Group 5: 45-60 years

Treatment:

Other: Non-intervention observational study

Group: >60 years

Treatment:

Other: Non-intervention observational study