Antibody Production Following H1N1 Influenza Vaccination... | NCT01008683

Studies
Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation

NCT01008683

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Nov 6, 2009Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

H1N1 Influenza

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

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Apr 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

Nov 5, 2009

First Submission Date that Met QC Criteria

Nov 5, 2009

First Posted Date

Nov 6, 2009Estimated

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

Nov 5, 2009

Last Update Posted Date

Nov 6, 2009Estimated

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

Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

In these patients the investigators will measure the specific antibody production.

Detailed Description

Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval.

In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stem cell and and heart transplant patients		Stem cell and and heart transplant patients

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

Exclusion Criteria:

Patients with unstable grafts.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hadas Lemberg	Contact			lhadas@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Dan Engelhard	Hadassah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D009976	Orthomyxoviridae Infections

Ancestor Terms

ID	Term
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided