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

NCT00383526 | Completed Phase 3

• 1 other identifier: GID17
• Study Type: interventional
• Target: 3,707
• Locations: 4 countries
• Sites: 4

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.

Conditions

Orthomyxoviridae Infection; Influenza; Myxovirus Infection

Keywords

Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; elderly

Outcome Measures

Primary Outcomes (1)

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

  21 days post-vaccination

Secondary Outcomes (1)

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

  Entire study period

Study Arms (2)

Study Group 1

EXPERIMENTAL

Biological: Inactivated, split-virion influenza vaccine

Study Group 2

ACTIVE COMPARATOR

Biological: Inactivated, split-virion influenza vaccine

Interventions

Inactivated, split-virion influenza vaccine BIOLOGICAL

Vaccine

Study Group 1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent Form signed.
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (4)

Unknown Facility

Antwerp, 2060, Belgium

Location

Unknown Facility

Angers, 49000, France

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Vilnius, LT-08117, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 19261173 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Orthomyxoviridae Infections; Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

IT (1); BE (1); FR (1); LI (1)