Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 4/21/2016 |
| Start Date: | January 2008 |
| End Date: | June 2008 |
Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age
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
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
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.
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.
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).
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