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OpenTrials
Completed

NCT Number: NCT01178918

Non-specific Response to H1N1 Vaccine

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.

Completed

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Key information

Conditions

Influenza H1N1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic of Respiratory and Allergic Diseases

Golnik, 4204, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination

    Time frame: At 3 weeks after vaccination

  2. T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination

    Time frame: At 11 weeks after vaccination.

Sponsors and collaborators

Lead sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Aug 10, 2010
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.