Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults

January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2256

Phase

  • Phase 3

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

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
Lot 1
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 1
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 2
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 3
Biological: Inactivated Split-virion influenza vaccine
Control Vaccine
Other Names:
  • Vaxigrip
Experimental: 2
Lot 2
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 1
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 2
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 3
Biological: Inactivated Split-virion influenza vaccine
Control Vaccine
Other Names:
  • Vaxigrip
Experimental: 3
Lot 3
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 1
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 2
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 3
Biological: Inactivated Split-virion influenza vaccine
Control Vaccine
Other Names:
  • Vaxigrip
Active Comparator: 4
Control
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 1
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 2
Biological: Inactivated Split-virion influenza vaccine
Vaccine Lot 3
Biological: Inactivated Split-virion influenza vaccine
Control Vaccine
Other Names:
  • Vaxigrip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine
Time Frame: 21 Days pot-vaccination
21 Days pot-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety of an inactivated, split-virion influenza vaccine.
Time Frame: 6 months post-vaccination
6 months post-vaccination

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

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, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 29, 2006

First Submitted That Met QC Criteria

September 29, 2006

First Posted (Estimate)

October 3, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GID23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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