Non-specific Response to H1N1 Vaccine | NCT01178918

Studies
Non-specific Response to H1N1 Vaccine

NCT01178918

Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Status

Completed

Last Update Posted

Feb 28, 2020Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Influenza H1N1

Interventions

Not provided

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 1, 2010Actual

Completion Date

Jul 1, 2012Actual

First Submitted Date

Aug 4, 2010

First Submission Date that Met QC Criteria

Aug 9, 2010

First Posted Date

Aug 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2020

Last Update Posted Date

Feb 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Korošec, Head of Laboratory, The University Clinic of Pulmonary and Allergic Diseases GolnikPrincipal Investigator

Lead Sponsor

The University Clinic of Pulmonary and Allergic Diseases GolnikOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Label	Type	Description	Intervention Names
Healthy volunteers from recipients of H1N1 vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic of Respiratory and Allergic Diseases		Golnik		4204	Slovenia