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

Tracking Information
First Received Date ^ICMJE	August 4, 2010
Last Updated Date	August 9, 2010
Start Date ^ICMJE	November 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: August 9, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01178918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Non-specific Response to H1N1 Vaccine
Official Title ^ICMJE	Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Influenza H1N1
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Healthy volunteers from recipients of H1N1 vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	15
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Slovenia

Administrative Information
NCT Number ^ICMJE	NCT01178918
Other Study ID Numbers ^ICMJE	KOPA-H1N1-01
Has Data Monitoring Committee	No
Responsible Party	Head of PMO, The University Clinic of Pulmonary and Allergic Diseases Golnik
Study Sponsor ^ICMJE	The University Clinic of Pulmonary and Allergic Diseases Golnik
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	The University Clinic of Pulmonary and Allergic Diseases Golnik
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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