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Non-specific Response to H1N1 Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by The University Clinic of Pulmonary and Allergic Diseases Golnik.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier:
NCT01178918
First received: August 4, 2010
Last updated: August 9, 2010
Last verified: August 2010
History of Changes
  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:

MedlinePlus related topics: Flu
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • T Cell Immune responce monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination [ Time Frame: At 11 weeks after vaccination. ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 4, 2010
Last Updated: August 9, 2010
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013