Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Grove City, Pennsylvania 16127


Purpose:

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


Study summary:

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.


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).


NCT ID:

NCT00623181


Primary Contact:

Study Director
Medical Monitor
Sanofi Pasteur, Inc


Backup Contact:

N/A


Location Contact:

Grove City, Pennsylvania 16127
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.