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

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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

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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