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

Primary Purpose

Orthomyxoviridae Infection, Influenza, Myxovirus Infection

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Inactivated Split-virion influenza vaccine

About this trial

This is an interventional prevention trial for Orthomyxoviridae Infection focused on measuring Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Adults

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

Aged 18 to 60 years on the day of inclusion.
Informed consent form signed.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman, inability to bear a child or negative urine pregnancy test at the first visit.

Exclusion Criteria :

Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Febrile illness (oral temperature >= 37.5°C, or rectal equivalent temperature >= 38.0°C) on the day of inclusion.
Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion.
Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
Blood or blood-derived products received in the past 3 months.
Any vaccination in the 4 weeks preceding the trial vaccination.
Vaccination planned in the 4 weeks following the trial vaccination.
Previous vaccination against influenza (in the previous 6 months).
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Lot 1

Lot 2

Lot 3

Control

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine

Secondary Outcome Measures

To provide information concerning the safety of an inactivated, split-virion influenza vaccine.

Full Information

NCT ID

NCT00383539

First Posted

September 29, 2006

Last Updated

January 10, 2014

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00383539

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthomyxoviridae Infection, Influenza, Myxovirus Infection

Keywords

Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Adults

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2256 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Lot 1

Arm Title

Arm Type

Experimental

Arm Description

Lot 2

Arm Title

Arm Type

Experimental

Arm Description

Lot 3

Arm Title

Arm Type

Active Comparator

Arm Description

Control

Intervention Type

Biological

Intervention Name(s)

Inactivated Split-virion influenza vaccine

Intervention Description

Vaccine Lot 1

Intervention Type

Biological

Intervention Name(s)

Inactivated Split-virion influenza vaccine

Intervention Description

Vaccine Lot 2

Intervention Type

Biological

Intervention Name(s)

Inactivated Split-virion influenza vaccine

Intervention Description

Vaccine Lot 3

Intervention Type

Biological

Intervention Name(s)

Inactivated Split-virion influenza vaccine

Other Intervention Name(s)

Vaxigrip

Intervention Description

Control Vaccine

Primary Outcome Measure Information:

Title

To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine

Time Frame

21 Days pot-vaccination

Secondary Outcome Measure Information:

Title

To provide information concerning the safety of an inactivated, split-virion influenza vaccine.

Time Frame

6 months post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Aged 18 to 60 years on the day of inclusion. Informed consent form signed. Able to attend all scheduled visits and to comply with all trial procedures. For a woman, inability to bear a child or negative urine pregnancy test at the first visit. Exclusion Criteria : Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. Febrile illness (oral temperature >= 37.5°C, or rectal equivalent temperature >= 38.0°C) on the day of inclusion. Participation in another clinical trial in the 4 weeks preceding the trial vaccination. Planned participation in another clinical trial during the present trial period. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) at a stage that could interfere with trial conduct or completion. Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures. Blood or blood-derived products received in the past 3 months. Any vaccination in the 4 weeks preceding the trial vaccination. Vaccination planned in the 4 weeks following the trial vaccination. Previous vaccination against influenza (in the previous 6 months). Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Angers

ZIP/Postal Code

49000

Country

France

City

Vilnius

ZIP/Postal Code

08117

Country

Lithuania

City

Madrid

ZIP/Postal Code

28041

Country

Spain

City

Bath

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

20372053

Citation

Arnou R, Eavis P, Pardo JR, Ambrozaitis A, Kazek MP, Weber F. Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18-60 years: Randomized, controlled, phase III trial. Hum Vaccin. 2010 Apr;6(4):346-54. doi: 10.4161/hv.6.4.10961. Epub 2010 Apr 15.

Results Reference

derived

PubMed Identifier

19261173

Citation

Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes. 2009 Mar 4;7:21. doi: 10.1186/1477-7525-7-21.

Results Reference

derived

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

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

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