NCT00289510

Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)

Single-Blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) With a License Egg Derived Influenza Vaccine

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 423 (planned)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated influenza vaccine (whole virion, Vero cell-derived)
BIOLOGICAL	Inactivated influenza vaccine (egg derived) [licensed control vaccine]

Timeline

• Start date: 2006-01-01
• First posted: 2006-02-10
• Last updated: 2015-10-09

Locations

3 sites across 2 countries: Austria, Germany