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

Phase 3

Completed

• Conditions: Influenza; Myxovirus Infection; Orthomyxoviridae Infection
• Interventions: Biological: Inactivated Split-virion influenza vaccine

• Registration Number: NCT00383539
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-03
• Primary Completion: 2007-07
• Study Completion: 2007-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2256

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Inactivated Split-virion influenza vaccine	Lot 3
2	Inactivated Split-virion influenza vaccine	Lot 2
1	Inactivated Split-virion influenza vaccine	Lot 1
4	Inactivated Split-virion influenza vaccine	Control

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine	21 Days pot-vaccination

Secondary Outcome Measures

Name	Time	Method
To provide information concerning the safety of an inactivated, split-virion influenza vaccine.	6 months post-vaccination