The Effectiveness of Influenza Vaccine Among Health Care... | NCT00265161

Studies
The Effectiveness of Influenza Vaccine Among Health Care Workers in a Hospital Setting.

NCT00265161

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Jun 1, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Influenza Vaccines

Interventions

Not provided

Countries

Israel

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

Aug 2006

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

Dec 2005

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Dec 12, 2005

First Submission Date that Met QC Criteria

Dec 13, 2005

First Posted Date

Dec 14, 2005Estimated

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

May 31, 2007

Last Update Posted Date

Jun 1, 2007Estimated

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

The study will be held in the winter of 2005-2007. The aim is to assess the effectiveness of the influenza vaccine in health care workers (HCW).

Detailed Description

The study will be held in the winter of 2005-2006. Groups of vaccinated HCW and not vaccinated HCW will be followed for symptoms suggestive of influenza. For each event a quick through test for influenza A or B will be done and if positive will be confirmed by viral study. Data regarding days of illness, absence from work, therapy etc., will be collected. Effectiveness will be calculated as well as cost/effectiveness of vaccination.

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previously healthy health care worker vaccinated or not

Exclusion Criteria:

Immunocompromised state

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan Miron, MD	HaEmek Medicak Center, Afula, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Dpt A', HaEmek Medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided