Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00703651
First received: June 19, 2008
Last updated: January 9, 2014
Last verified: January 2014

June 19, 2008
January 9, 2014
September 2003
May 2006   (final data collection date for primary outcome measure)
  • To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. [ Time Frame: 21days 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 ]
Same as current
Complete list of historical versions of study NCT00703651 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults

This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.

Primary Objective:

To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.

Secondary Objective:

To evaluate the safety profile during the 21-day period following each vaccination in each study group

This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Influenza
  • Orthomyxoviridae Infection
  • Myxovirus Infection
  • Biological: Inactivated, split-virion influenza vaccine
    0.1 mL, ID. 1 injection/year for 3 years
  • Biological: Inactivated, split-virion influenza vaccine
    0.1 mL, ID. 1 injection/year for 3 years.
  • Biological: Inactivated, split-virion influenza vaccine
    0.5 mL, IM. 1 injection/year for 3 years
    Other Name: Vaxigrip®
  • Experimental: 1
    Intervention: Biological: Inactivated, split-virion influenza vaccine
  • Experimental: 2
    Intervention: Biological: Inactivated, split-virion influenza vaccine
  • Active Comparator: 3
    Intervention: Biological: Inactivated, split-virion influenza vaccine
Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1150
July 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria :

  • Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
  • For woman of child-bearing potential, negative urine pregnancy test at V#01
  • Use of effective contraception prior to and during the trial
  • Subject available during the trial period
  • Subject able to read and understand the informed consent form
  • Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).

Exclusion Criteria :

  • Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
  • Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic)
  • Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
  • Vaccination against influenza within the 6 months preceding V#01
  • Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
  • Breast-feeding
  • Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding V#01 or ongoing
  • Immunoglobulin injection within the 3 months preceding V#01
  • Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
  • Subject having received extracted pituitary hormones
  • Subjects who participated in the GID01 study (Lithuanian centers)
Both
18 Years to 57 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Lithuania
 
NCT00703651
GID02
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasterur Inc
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP