A New Flu Virus of Swine Origin, Novel Influenza A (H1N1)
Conditions
Keywords
Swine Flu H1N1 vaccine, Adjuvanted flu cell culture derived
Brief summary
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects | 6 months |
| 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 | 6 Months |
Countries
Chile, Colombia, Germany, Switzerland
Outcome results
None listed