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OpenTrials
Completed

NCT Number: NCT00554333

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

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flu-ID 15μg

Biological

Inactivated Split-Virion Influenza Vaccine for Intradermal Route

Inactivated adjuvanted Influenza Vaccine

Biological

Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Primary outcomes

  1. Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.

    Time frame: 21 days

Secondary outcomes

  1. Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]

    Time frame: 21 days

  2. Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21

    Time frame: 21 days

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. Answers to the Vaccination Comfort Questionnaire completed on D21

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 6, 2007
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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