Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.

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Detailed Description

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Participants will be randomized at visit one to either receive self-administered or nurse-administered intradermal influenza vaccine (Intanza). A blood sample will be taken prior to vaccination and 21 days post-vaccination. Participants will record information in a memory aid for 7 days including daily temperatures, solicited, unsolicited and general reactions. They will be called on study Day 8 to collect this information. Participants will return 21-24 days later for follow-up serology and review of adverse events.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intanza - self-administered

Self-administered intradermal influenza vaccine

Group Type ACTIVE_COMPARATOR

Intanza

Intervention Type BIOLOGICAL

0.1 mL of Intanza intradermally at visit # 1

Intanza - nurse-administered

Nurse-administered intradermal influenza vaccine

Group Type ACTIVE_COMPARATOR

Intanza

Intervention Type BIOLOGICAL

0.1 mL of Intanza intradermally at visit #1

Interventions

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Intanza

0.1 mL of Intanza intradermally at visit # 1

Intervention Type BIOLOGICAL

Intanza

0.1 mL of Intanza intradermally at visit #1

Intervention Type BIOLOGICAL

Other Intervention Names

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Influenza Vaccine (Split Virion, Inactivated) Influenza Vaccine (Split Virion, Inactivated)

Eligibility Criteria

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Inclusion Criteria

* Medically stable persons between age of 18-60
* Available during the trial period and for follow-up
* Able to read, understand, and sign informed consent
* Able to be contacted by telephone for follow-up of adverse events

Exclusion Criteria

* Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
* Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
* Receipt of other licensed vaccines within the preceding 4 weeks
* History of a severe reaction following influenza vaccination
* Use of cytotoxic therapy or biologic modifiers in the previous 2 years.
* Plans to receive cytotoxic therapy during the study period.
* Concurrent acute moderate to severe illness. (Vaccination will be deferred until recovery. Subjects with mild illnesses with fever ≤37.8ºC orally may be enrolled).
* History of medical disorder associated with immunosuppression (eg. including HIV-infected individuals, transplant recipients)
* History of chronic lung, cardiac, renal or liver disease, which has required hospitalization in the last year.
* Receipt of any high-dose daily systemic corticosteroids (inhaled steroids are acceptable) within two weeks of study entry. High dose is defined as a dose of 20 mg of prednisone daily or its equivalent. Topical steroids are allowed.
* Failure to give written, informed consent
* History of febrile illness (\>37.8ºC orally) within the past 72 hours (immunization may be deferred).
* Known allergy to eggs or other components of vaccine (i.e., thimerosal)
* History of Guillain-Barré Syndrome (GBS)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes