DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 subjects

To 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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017