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

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00554333
First received: November 5, 2007
Last updated: April 3, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Sanofi Pasteur MSD:

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554333

Locations
Belgium
Antwerpen, Belgium
Massemen, Belgium
Wilrijk, Belgium
France
Angers, France
Cherbourg, France
Laval, France
Seysses, France
Tierce, France
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD Sanofi Pasteur MSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional 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
Study First Received: November 5, 2007
Last Updated: April 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

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 May 21, 2013