NCT00560066

Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,398 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.

Conditions

• Seasonal Influenza
• Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Cell-derived influenza vaccine	1 dose of 0.5 mL in the deltoid region of the non-dominant arm
BIOLOGICAL	Egg-derived influenza vaccine	1 dose of 0.5 mL in the deltoid region of the non-dominant arm

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-11-19
• Last updated: 2016-02-17
• Results posted: 2013-04-18

Locations

15 sites across 1 country: Germany