Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Novel Influenza A (H1N1); A New Flu Virus of Swine Origin
Intervention: Non-intervention observational study (Other)
Phase: N/A
Status: Completed
Sponsored by: Novartis Vaccines
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.
Clinical Details
Official title: A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Celtura
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjectsTo characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects
Secondary outcome: To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination
Eligibility
Minimum age: 6 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Fundación Universitaria de Ciencias de Salud- Hospital San José Calle, 10 No 18-75 Bogotá, Colombia
Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI, Calle 66 # 40-07 - Bogotá, Colombia
Hospital local de Yopal E.S.E, Calle 9 No. 24-37 - Yopal, Casanare, Colombia
Clinica del Country, Carrera 16 No. 82-57 Bogotá, Colombia
Hospital Universitario Infantil San José, Carrera 52 No. 67A-71 - Barrios Unidos - Bogotá, Colombia
CAIMED - Centro de Atencion e Investigación Medica, Cra. 42 A No. 17-50, Colombia
Augustenburger Platz 1, Berlin, Germany
Policlinique Médicale Universitaire, Rue du Bugnon 44, CH-1011 Lausanne, Switzerland
Institute of Social and Preventive Medicine, Division of Communicable Diseases, Hirschengraben 84, CH-8001 Zürich, Switzerland
Clinica Indisa, Av. Santa Maria, Santiago 1810, Chile
Additional Information
Starting date: December 2009
Last updated: October 4, 2011
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