Skip to main content
OpenTrials
Completed

NCT Number: NCT00776438

Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines

To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.

Objectives:

* To describe the immune response per age group and vaccine group after vaccination. * To describe the safety of the vaccines per age group and per vaccine group after vaccination.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lyon Sud, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
  • Provision of a signed informed consent
  • Able to attend all scheduled visits and comply with all trial procedures
  • For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until 4 weeks after vaccination
  • Entitlement to national social security.

Exclusion criteria

  • For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected 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
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Current alcohol abuse or drug addiction, which may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
  • Previous vaccination against Influenza in the previous 6 months
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Febrile illness (oral temperature >=37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

Treatment and study plan

Inactivated, split-virion, influenza vaccine

Biological

0.1 mL, Intradermal

Inactivated, split-virion influenza vaccine

Biological

0.1 mL, Intradermal

Primary outcomes

  1. To provide information concerning immune response to an inactivated, split-virion, influenza vaccine.

    Time frame: 21 days post-vaccination

  2. To provide information concerning the safety of inactivated, split-virion, influenza vaccine.

    Time frame: 21 days post-vaccination and entire study duration

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated Either With an Inactivated Influenza Vaccine Administered Via the Intradermal Route or an Inactivated Influenza Vaccine Administered Via the Intramuscular Route

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2008
Registry last updated
Jun 17, 2015

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.

Published trials that share one or more normalized conditions with this study.