NCT00161811

Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005

Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety After a Single Vaccination With Three Different Lots of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell-derived) in Comparison to a Licensed Egg Derived Influenza Vaccine for Season 2004/2005.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,400 (planned)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objectives of the study are to assess the immunogenicity and safety among three different lots of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Vero Cell-derived Influenza Vaccine
BIOLOGICAL	Egg cell-derived Influenza Vaccine

Timeline

• Start date: 2004-11-01
• Completion: 2005-07-01
• First posted: 2005-09-13
• Last updated: 2015-10-09

Locations

4 sites across 2 countries: Austria, Germany