Non-specific Response to H1N1 Vaccine

February 26, 2020 updated by: Peter Korošec, The University Clinic of Pulmonary and Allergic Diseases Golnik

Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Golnik, Slovenia, 4204
        • University Clinic of Respiratory and Allergic Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy volunteers from recipients of H1N1 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
Time Frame: At 3 weeks after vaccination
At 3 weeks after vaccination
T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
Time Frame: At 11 weeks after vaccination.
At 11 weeks after vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (Estimate)

August 10, 2010

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOPA-H1N1-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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