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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fluzone Intradermal First, Then Fluzone Intramuscular

Group Type EXPERIMENTAL

Fluzone: Influenza virus vaccine

Intervention Type BIOLOGICAL

0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid

Fluzone Intramuscular First, Then Fluzone Intradermal

Group Type EXPERIMENTAL

Fluzone: Influenza virus vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid

Interventions

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Fluzone: Influenza virus vaccine

0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid

Intervention Type BIOLOGICAL

Fluzone: Influenza virus vaccine

0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid

Intervention Type BIOLOGICAL

Other Intervention Names

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Fluzone® Fluzone®

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes