Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

Completed · Phase 2

Conditions studied: Influenza

In brief

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

Key facts

Study ID

NCT00623181

Run by

Sanofi Pasteur, a Sanofi Company

People needed

110

Starts

2008-01-01

Expected to finish

2008-06-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Grove City, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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