Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

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

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-01-31

Brief Summary

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The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Recombinant Influenza HA Vaccine (H5N1)

one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain

Intervention Type BIOLOGICAL

Other Intervention Names

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UMN-0501

Eligibility Criteria

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Inclusion Criteria

* Subjects who completed a priming study (JPIP501-01a, NCT00980447)
* Male and female healthy adults
* Written informed consent obtained from the subject before study entry

Exclusion Criteria

* History of H5N1 influenza or vaccination of other H5N1 influenza vaccines
* Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder
* Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus
* Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines)
* Treatment with disallowed drugs including other study drugs
* Pregnant or nursing (lactating) women

Minimum Eligible Age

21 Years

Maximum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes