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
  Purpose

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


Condition Intervention Phase
Influenza
Orthomyxoviridae Infection
Myxovirus Infection
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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1150
Study Start Date: September 2003
Study Completion Date: July 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Inactivated, split-virion influenza vaccine
0.1 mL, ID. 1 injection/year for 3 years
Experimental: 2 Biological: Inactivated, split-virion influenza vaccine
0.1 mL, ID. 1 injection/year for 3 years.
Active Comparator: 3 Biological: Inactivated, split-virion influenza vaccine
0.5 mL, IM. 1 injection/year for 3 years
Other Name: Vaxigrip®

Detailed Description:

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.

  Eligibility

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703651

Locations
Belgium
Gribomont, Belgium
Kraainem, Belgium
Linkebeek, Belgium
Molenbeek, Belgium
Thuin, Belgium
Czech Republic
Hradec Kralove, Czech Republic
Lithuania
Kaunas, Lithuania
Vilnius, Lithuania
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasterur 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: NCT00703651     History of Changes
Other Study ID Numbers: GID02
Study First Received: June 19, 2008
Last Updated: January 9, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Sanofi:
Influenza
Orthomyxoviridae Infection
Inactivated, Split-virion influenza vaccine
Intradermal injection
Adults.

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 April 16, 2014