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

January 9, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gribomont, Belgium
      • Kraainem, Belgium
      • Linkebeek, Belgium
      • Molenbeek, Belgium
      • Thuin, Belgium
  • Czech Republic
      • Hradec Kralove, Czech Republic
  • Lithuania
      • Kaunas, Lithuania
      • Vilnius, Lithuania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 57 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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 Names:
  • Vaxigrip®
Experimental: 2
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 Names:
  • Vaxigrip®
Active Comparator: 3
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 Names:
  • Vaxigrip®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.
Time Frame: 21days post-vaccination
21days post-vaccination
To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine
Time Frame: 21 days post-vaccination and entire study duration
21 days post-vaccination and entire study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Investigators

  • Study Director: Medical Monitor, Sanofi Pasterur Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (Estimate)

June 23, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GID02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on Inactivated, split-virion influenza vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe