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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00554333

Influenza

COMPLETED PHASE3

Immunogenicity Study of the Influenza Vaccine in Adults

NCT00258934

Orthomyxoviridae Infections Influenza

COMPLETED PHASE2

A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults

NCT01089660

Influenza Swine-origin A/H1N1 Influenza

COMPLETED PHASE2

Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)

NCT00945438

Influenza

COMPLETED PHASE2

Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older

NCT00848848

Influenza

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Orthomyxovirus Infections Myxovirus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group 1

Adult, age 18 to 40 years

Group Type EXPERIMENTAL

Inactivated, split-virion, influenza vaccine

Intervention Type BIOLOGICAL

0.1 mL, Intradermal

Study Group 2

Adult, age 18 to 40 years

Group Type EXPERIMENTAL

Inactivated, split-virion, influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Study Group 3

Elderly, age 60 to 85 years

Group Type EXPERIMENTAL

Inactivated, split-virion influenza vaccine

Intervention Type BIOLOGICAL

0.1 mL, Intradermal

Study Group 4

Elderly, age 60 to 85 years

Group Type EXPERIMENTAL

Inactivated, split-virion influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inactivated, split-virion, influenza vaccine

0.1 mL, Intradermal

Intervention Type BIOLOGICAL

Inactivated, split-virion, influenza vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Inactivated, split-virion influenza vaccine

0.1 mL, Intradermal

Intervention Type BIOLOGICAL

Inactivated, split-virion influenza vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vaxigrip® Vaxigrip®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No