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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00623181

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

Condition	Intervention	Phase
Influenza	Biological: Fluzone: Influenza virus vaccine	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Preference for route of administration on Day 0 immediately after vaccination, and on Days 3 and 7 [ Time Frame: 7 Days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To observe solicited injection site reactions, solicited systemic reactions, and SAEs. [ Time Frame: 28 Days post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Fluzone: Influenza virus vaccine ID Right deltoid, IM Left deltoid
2: Experimental	Biological: Fluzone: Influenza virus vaccine IM Right deltoid, ID Left deltoid

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

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623181

Locations

United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15241

Grove City, Pennsylvania, United States, 16127

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur, Inc

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur, Inc ( Medical Director )
Study ID Numbers:	FID30
Study First Received:	February 6, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00623181
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza
Influenza virus

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009