Non-specific Response to H1N1 Vaccine

Influenza H1N1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178918
• Other study ID #: KOPA-H1N1-01
• Status: Completed
• Start date: November 2009
• Est. completion date: July 1, 2012

Study information

• Verified date: February 2020
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 1, 2012
• Est. primary completion date: December 1, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza H1N1
• Influenza, Human

Locations

Country	Name	City	State
Slovenia	University Clinic of Respiratory and Allergic Diseases	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination		At 3 weeks after vaccination
Primary	T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination		At 11 weeks after vaccination.