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

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ClinicalTrials.gov Identifier: NCT00554333
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE November 5, 2007
First Posted Date  ICMJE November 6, 2007
Last Update Posted Date March 16, 2018
Study Start Date  ICMJE October 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine
Official Title  ICMJE 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
Brief Summary

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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Flu-ID 15μg
    Inactivated Split-Virion Influenza Vaccine for Intradermal Route
  • Biological: Inactivated adjuvanted Influenza Vaccine
    Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
Study Arms  ICMJE
  • Experimental: 1
    Inactivated Split-Virion Influenza Vaccine for Intradermal Route
    Intervention: Biological: Flu-ID 15μg
  • Active Comparator: 2
    Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
    Intervention: Biological: Inactivated adjuvanted Influenza Vaccine
Publications * Van Damme P, Arnou R, Kafeja F, Fiquet A, Richard P, Thomas S, Meghlaoui G, Samson SI, Ledesma E. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
795
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2007)
790
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00554333
Other Study ID Numbers  ICMJE FID01C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP