NCT00383539

Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,256 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process. Secondary Objectives: Immunogenicity To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers. To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96). Safety: To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile. To describe the safety profile after vaccination. Comfort of the vaccination assessment: To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.

Conditions

• Orthomyxoviridae Infection
• Influenza
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Split-virion influenza vaccine	Vaccine Lot 1
BIOLOGICAL	Inactivated Split-virion influenza vaccine	Vaccine Lot 2
BIOLOGICAL	Inactivated Split-virion influenza vaccine	Vaccine Lot 3
BIOLOGICAL	Inactivated Split-virion influenza vaccine	Control Vaccine

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-07-01
• Completion: 2007-12-01
• First posted: 2006-10-03
• Last updated: 2014-01-14

Locations

4 sites across 4 countries: France, Lithuania, Spain, United Kingdom