Clinical trial NCT00623181: Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Official title: Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Influenza virus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.

To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

Detailed description: The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to \< 50 years of age on the day of inclusion.
* Informed consent form signed.
* Able to attend both scheduled visits and to 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 at least 4 weeks after vaccination.

Exclusion Criteria:

* Subject currently breast-feeding.
* Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.
* Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.
* Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
* Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* Personal history of Guillain-Barre syndrome.
* Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures.
* Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral).
* Influenza vaccination received this season (2007-2008).

Primary outcomes:
measure: Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
timeFrame: Day 0 and up to 7 days post-vaccination
measure: Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
timeFrame: Days 0, 3, and 7 after vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection
timeFrame: Days 0 through 7 post-vaccination
measure: Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection
timeFrame: Days 0 through 7 post-vaccination
Locations:
city: Grove City
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
Study officials:
affiliation: Sanofi Pasteur, Inc
name: Medical Monitor
role: STUDY_DIRECTOR
References: