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Non-specific Response to H1N1 Vaccine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by The University Clinic of Pulmonary and Allergic Diseases Golnik.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178918
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The University Clinic of Pulmonary and Allergic Diseases Golnik
  Purpose

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.


Condition
Influenza H1N1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine

Resource links provided by NLM:


Further study details as provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:

Primary Outcome Measures:
  • T Cell Immune responce monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination [ Time Frame: At 3 weeks after vaccination ]
  • T Cell Immune responce monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination [ Time Frame: At 11 weeks after vaccination. ]

Estimated Enrollment: 15
Study Start Date: November 2009
Groups/Cohorts
Healthy volunteers from recipients of H1N1 vaccine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178918


Locations
Slovenia
University Clinic of Respiratory and Allergic Diseases
Golnik, Slovenia, 4204
Sponsors and Collaborators
The University Clinic of Pulmonary and Allergic Diseases Golnik
  More Information

Responsible Party: Head of PMO, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01178918     History of Changes
Other Study ID Numbers: KOPA-H1N1-01
First Submitted: August 4, 2010
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
Last Verified: August 2010

Keywords provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:
Influenza H1N1
Vaccine
Adjuvant
T Lymphocytes
Non-specific response
Interleukin-2
Non-specific T cell responce

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs