A New Flu Virus of Swine Origin, Pandemic Influenza A (H1N1)
Conditions
Keywords
Pandemic influenza A (H1N1) vaccine, Adjuvanted
Brief summary
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.
Interventions
Non-intervention observational study
Sponsors
Novartis Vaccines
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify the safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects. | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine. | 6 months |
Countries
Argentina, Netherlands
Outcome results
None listed