NCT01178918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

August 4, 2010

Last Update Submit

February 26, 2020

Conditions

Influenza H1N1

Keywords

Influenza H1N1VaccineAdjuvantT LymphocytesNon-specific responseInterleukin-2Non-specific T cell response

Outcome Measures

Primary Outcomes (2)

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

    At 3 weeks after vaccination

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

    At 11 weeks after vaccination.

Study Arms (1)

Healthy volunteers from recipients of H1N1 vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

You may qualify if:

  • Recipients of H1N1 influenza vaccine.
  • Healthy individuals with no signs of influenza or other infectious disease.

You may not qualify if:

  • Signs of influenza or other infectious disease in 1 month before study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Respiratory and Allergic Diseases

Golnik, 4204, Slovenia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Laboratory

Study Record Dates

First Submitted

August 4, 2010

First Posted

August 10, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

July 1, 2012

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

SL(1)