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Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554333
First Posted: November 6, 2007
Last Update Posted: April 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MCM Vaccines B.V.
  Purpose

Primary objective:

* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

  • Immunogenicity

    • To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
    • To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
  • Safety

    - To describe the safety profile after vaccination in each group

  • Acceptability

    • To describe the pain at the injection site
    • To describe the comfort of the injection

Condition Intervention Phase
Influenza Biological: Flu-ID 15μg Biological: Inactivated adjuvanted Influenza Vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-Label, Multi-Centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older

Resource links provided by NLM:


Further study details as provided by MCM Vaccines B.V.:

Primary Outcome Measures:
  • Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0] [ Time Frame: 21 days ]
  • Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21 [ Time Frame: 21 days ]
  • Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0 [ Time Frame: 21 days ]
  • Seroconversion or significant increase status at D21: ≥4-fold increase from pre- to post-vaccination anti-HA individual titre on D21 for subjects with a pre-vaccination anti-HA individual titre ≥10 (1/dil) [ Time Frame: 21 days ]
  • Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection site adverse reactions and systemic adverse reactions occurring from D0 to D7 after vaccination [ Time Frame: 7 days ]
  • Occurrence of some solicited adverse reactions occurring from D0 to D3 after vaccination as defined by the EMEA Note for Guidance [CPMP/BWP/214/96] [ Time Frame: 3 days ]
  • Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of unsolicited (spontaneously reported) adverse events (injection site and systemic) occurring from D0 to visit 2 [ Time Frame: 21 days (plus or minus 3 days) ]
  • Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of serious adverse events occurring from D0 to visit 2 [ Time Frame: 21 days (plus or minus 3 days) ]
  • Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale [ Time Frame: 1 day (day of vaccination) ]
  • Answers to the Vaccination Comfort Questionnaire completed on D21 [ Time Frame: 21 days ]

Estimated Enrollment: 790
Study Start Date: October 2007
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: 1
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
Biological: Flu-ID 15μg
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
Active Comparator: 2
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
Biological: Inactivated adjuvanted Influenza Vaccine
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 65 years or older on the day of inclusion

Exclusion Criteria:

  • Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
  • Unstable chronic illness
  • Congenital or acquired immunodeficiency,
  • Any blood or blood-derived product in the past 3 months
  • Current abuse of alcohol or drug addiction
  • Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
  • Any vaccination against influenza in the past 6 months
  • Subjects who previously received a vaccination against influenza by intradermal route
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554333


Locations
Belgium
Antwerpen, Belgium
Massemen, Belgium
Wilrijk, Belgium
France
Angers, France
Cherbourg, France
Laval, France
Seysses, France
Tierce, France
Sponsors and Collaborators
MCM Vaccines B.V.
Investigators
Study Director: Anne FIQUET, MD MCM Vaccines B.V.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00554333     History of Changes
Other Study ID Numbers: FID01C
First Submitted: November 5, 2007
First Posted: November 6, 2007
Last Update Posted: April 6, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs