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
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: 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:
Communicable Diseases
Infection
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 28, 2014