Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine

Novartis

Status: Completed

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

Treatments: Other: Non-intervention observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT01037855

V110_07OB

Details and patient eligibility

About

This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.

Enrollment: 4,028 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 6 months
• Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, 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

4,028 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