Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine

A New Flu Virus of Swine Origin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037855
• Other study ID #: V110_07OB
• Status: Completed
• Phase: N/A
• First received: December 20, 2009
• Last updated: March 13, 2017
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4028
• Est. completion date: January 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• A New Flu Virus of Swine Origin
• Influenza, Human
• Novel Influenza A (H1N1)

Intervention

Other:
• Non-intervention observational study
Non-intervention observational study

Locations

Country	Name	City	State
Chile	Clinica Indisa	Av. Santa Maria	Santiago
Colombia	Fundación Universitaria de Ciencias de Salud- Hospital San José Calle	Bogota
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
Switzerland	Institute of Social and Preventive Medicine, Division of Communicable Diseases	Hirschengraben 84	CH-8001 Zürich
Switzerland	Policlinique Médicale Universitaire	Rue du Bugnon 44	CH-1011 Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Chile,  Colombia,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects		6 months
Primary	To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects		6 months
Secondary	To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination		6 Months