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Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
This study has been completed.
First Received: September 29, 2006   Last Updated: September 24, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00383539
  Purpose

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.


Condition Intervention Phase
Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Biological: Inactivated Split-virion influenza vaccine
Phase III

MedlinePlus related topics: Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine [ Time Frame: 21 Days pot-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of an inactivated, split-virion influenza vaccine. [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 2256
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Lot 1
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 1
2: Experimental
Lot 2
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 2
3: Experimental
Lot 3
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 3
4: Active Comparator
Control
Biological: Inactivated Split-virion influenza vaccine
Control Vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383539

Locations
France
ANGERS, France, 49000
Lithuania
Vilnius, Lithuania, 08117
Spain
Madrid, Spain, 28041
United Kingdom
Bath, United Kingdom
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers: GID23
Study First Received: September 29, 2006
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00383539     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency;   Lithuania: State Medicine Control Agency - Ministry of Health;   Spain: Ministry of Health and Consumption;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi-Aventis:
Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Adults

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

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

ClinicalTrials.gov processed this record on May 07, 2009