Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine
NCT ID: NCT01098786
Last Updated: 2017-03-14
Study Results
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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COMPLETED
556 participants
OBSERVATIONAL
2010-02-28
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy
Cell-derived A/H1N1 influenza HA vaccine
Single group vaccinated
Interventions
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Cell-derived A/H1N1 influenza HA vaccine
Single group vaccinated
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.
The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
3. The person shows obvious fever.
4. The person obviously suffers from serious acute disease.
5. The person has obviously shown anaphylaxis due to an ingredient of this vaccine.
6. The person is otherwise in an inappropriate state to receive preventive vaccination.
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Locations
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National Hospital Organization Kumamoto Medical Center
Chuo-ku, Kumamoto, Japan
Countries
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Other Identifiers
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V110_11
Identifier Type: -
Identifier Source: org_study_id
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