Immunogenicity Study of the Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00258934
First received: November 24, 2005
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions.

Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes.

Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.


Condition Intervention Phase
Orthomyxoviridae Infections
Influenza
Biological: Inactivated, split-virion influenza vaccine
Biological: Inactivated, split-virion, influenza virus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of influenza vaccination. [ Time Frame: 21 Days and 2 Years post-vaccination 1 ] [ Designated as safety issue: No ]

Enrollment: 978
Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Inactivated, split-virion influenza vaccine
0.1 mL single annual dose
Active Comparator: 2 Biological: Inactivated, split-virion, influenza virus
0.5 mL single annual dose
Other Name: Vaxigrip®

  Eligibility

Ages Eligible for Study:   18 Years to 57 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 to 57 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 V01
  • For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least 4 weeks prior to, and at least four weeks after, the first vaccination.

At Year 1 (Visit 05):

-Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05

At Year 2 (Visit 07):

-Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07

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 (rectal equivalent temperature >= 38.0°C) on the day of inclusion
  • Breast-feeding
  • 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 six months; or long-term systemic corticosteroid therapy.
  • Chronic illness 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 three months
  • Any vaccination in the four weeks preceding the first trial vaccination
  • Vaccination planned in the four weeks following the first trial vaccination
  • Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine
  • Thrombocytopenia or bleeding disorder contraindicating IM vaccination
  • Subject deprived of freedom by an administrative or court order; or in an emergency setting; or hospitalized without his/her consent.
  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: NCT00258934

Locations
Belgium
Antwerpen, Belgium
Ghent, Belgium
Germany
Hamburg, Germany
Switzerland
Allschwil, Switzerland
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00258934     History of Changes
Other Study ID Numbers: GID15
Study First Received: November 24, 2005
Last Updated: January 10, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Inactivated
Split-virion influenza vaccine
adults
Myxovirus Infection
Orthomyxovirus Infection

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 August 28, 2014