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Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the Elderly

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, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged over 60 years on the day of inclusion.
Informed Consent Form signed.
Able to attend all scheduled visits and to comply with all trial procedures.

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 four weeks preceding the first 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 first trial vaccination.
Vaccination planned in the 4 weeks following the first trial vaccination.
Previous vaccination against influenza (in the previous 6 months) with the trial vaccine or another vaccine.
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 Type

Experimental

Active Comparator

Arm Label

Study Group 1

Study Group 2

Arm Description

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza vaccine

Secondary Outcome Measures

To provide information concerning the safety of Inactivated, Split-Virion Influenza vaccine

Full Information

NCT ID

NCT00383526

First Posted

September 29, 2006

Last Updated

January 10, 2014

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00383526

Brief Title

Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the Elderly

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

September 2009 (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

Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate. However, due to their weak antibody response an improvement of the immune response to influenza vaccination remains an unmet medical need. The purpose of an investigational influenza vaccine candidate administered by an alternate route is to improve immune responses to the vaccine in the elderly population, which could provide additional reductions in influenza-associated morbidity and mortality in this population. Primary Objective: To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination. Secondary Objectives: Immunogenicity: To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after the first vaccination in a subset of subjects. To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96) specific to elderly subjects. Safety: To demonstrate the tolerance of the investigational vaccine after the first vaccination, in terms of pre-defined solicited systemic reactions. To describe the safety profile after each vaccination. To describe the effect of repetitive injections on the safety profile.

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, elderly

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3707 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group 1

Arm Type

Experimental

Arm Title

Study Group 2

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Inactivated, split-virion influenza vaccine

Intervention Description

Vaccine

Intervention Type

Biological

Intervention Name(s)

Inactivated, split-virion influenza vaccine

Other Intervention Name(s)

Vaxigrip®

Intervention Description

Vaccine

Primary Outcome Measure Information:

Title

To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza vaccine

Time Frame

21 days post-vaccination

Secondary Outcome Measure Information:

Title

To provide information concerning the safety of Inactivated, Split-Virion Influenza vaccine

Time Frame

Entire study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged over 60 years on the day of inclusion. Informed Consent Form signed. Able to attend all scheduled visits and to comply with all trial procedures. 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 four weeks preceding the first 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 first trial vaccination. Vaccination planned in the 4 weeks following the first trial vaccination. Previous vaccination against influenza (in the previous 6 months) with the trial vaccine or another vaccine. 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

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

City

Angers

ZIP/Postal Code

49000

Country

France

City

Genova

ZIP/Postal Code

16132

Country

Italy

City

Vilnius

ZIP/Postal Code

LT-08117

Country

Lithuania

12. IPD Sharing Statement

Citations:

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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Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the Elderly

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