Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00776438
First received: October 17, 2008
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.

Objectives:

  • To describe the immune response per age group and vaccine group after vaccination.
  • To describe the safety of the vaccines per age group and per vaccine group after vaccination.

Condition Intervention Phase
Influenza
Orthomyxovirus Infections
Myxovirus Infection
Biological: Inactivated, split-virion, influenza vaccine
Biological: Inactivated, split-virion influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated Either With an Inactivated Influenza Vaccine Administered Via the Intradermal Route or an Inactivated Influenza Vaccine Administered Via the Intramuscular Route

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning immune response to an inactivated, split-virion, influenza vaccine. [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • To provide information concerning the safety of inactivated, split-virion, influenza vaccine. [ Time Frame: 21 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: September 2007
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1
Adult, age 18 to 40 years
Biological: Inactivated, split-virion, influenza vaccine
0.1 mL, Intradermal
Experimental: Study Group 2
Adult, age 18 to 40 years
Biological: Inactivated, split-virion, influenza vaccine
0.5 mL, Intramuscular
Other Name: Vaxigrip®
Experimental: Study Group 3
Elderly, age 60 to 85 years
Biological: Inactivated, split-virion influenza vaccine
0.1 mL, Intradermal
Experimental: Study Group 4
Elderly, age 60 to 85 years
Biological: Inactivated, split-virion influenza vaccine
0.5 mL, Intramuscular
Other Name: Vaxigrip®

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
  • Provision of a signed informed consent
  • Able to attend all scheduled visits and comply with all trial procedures
  • For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until 4 weeks after vaccination
  • Entitlement to national social security.

Exclusion Criteria :

  • For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected 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
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Current alcohol abuse or drug addiction, which may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
  • Previous vaccination against Influenza in the previous 6 months
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Febrile illness (oral temperature >=37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776438

Locations
France
Lyon Sud, France
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00776438     History of Changes
Other Study ID Numbers: GID25
Study First Received: October 17, 2008
Last Updated: January 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Myxovirus Infection
Inactivated Split-virion influenza vaccine
Adults
Elderly

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014