Status:
COMPLETED
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE2
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 r...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00623181
Start Date
January 1 2008
End Date
June 1 2008
Last Update
April 14 2016
Active Locations (2)
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1
Grove City, Pennsylvania, United States, 16127
2
Pittsburgh, Pennsylvania, United States, 15241