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

Novartis logo

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

Trial contacts and locations

10

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems