Non-specific Response to H1N1 Vaccine

NCT ID: NCT01178918

Last Updated: 2020-02-28

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

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-07-01

Brief Summary

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This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.

Detailed Description

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Conditions

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Influenza H1N1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers from recipients of H1N1 vaccine

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Recipients of H1N1 influenza vaccine.
* Healthy individuals with no signs of influenza or other infectious disease.

Exclusion Criteria

* Signs of influenza or other infectious disease in 1 month before study participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role lead

Responsible Party

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Peter Korošec

Head of Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Clinic of Respiratory and Allergic Diseases

Golnik, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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KOPA-H1N1-01

Identifier Type: -

Identifier Source: org_study_id

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