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Non-specific Response to H1N1 Vaccine

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ClinicalTrials.gov Identifier: NCT01178918
Recruitment Status : Unknown
Verified August 2010 by The University Clinic of Pulmonary and Allergic Diseases Golnik.
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2010
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
The University Clinic of Pulmonary and Allergic Diseases Golnik

Brief Summary:

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 or disease
Influenza H1N1

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine
Study Start Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Group/Cohort
Healthy volunteers from recipients of H1N1 vaccine



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


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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.

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

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 Posted: August 10, 2010    Key Record Dates
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