NCT01590381

Brief Summary

The purpose of this study is to assess HBV immunity and institute policy regarding the Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during infancy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 2, 2012

Status Verified

May 1, 2012

Enrollment Period

1.1 years

First QC Date

May 1, 2012

Last Update Submit

May 1, 2012

Conditions

Study Arms (10)

personnel in medical training - COURSE 1

personnel in medical training - COURSE 2

personnel in medical training - COURSE 3

personnel in medical training - COURSE 4

personnel in medical training - COURSE 5

personnel in medical training - COURSE 6

personnel in medical training - COURSE 7

personnel in medical training - COURSE 8

personnel in medical training - COURSE 9

personnel in medical training - COURSE 10

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population will consist of both males and females who were born after January 1st 1992, who are in medical training at the Medical Corps Training Base.

You may qualify if:

  • Soldiers born on or after January 1st, 1992
  • Soldiers taking part in a medical training course
  • Soldiers that signed an informed consent form

You may not qualify if:

  • Born before January 1st, 1992
  • Soldiers with previous known infection with HBV
  • Soldiers with documented evidence of immunity against HBV
  • Soldiers that refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israeli Defense Forces

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples from study subjects vaccinated at infancy, before and after booster dose.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Michael Hartal, MD

    International Diabetes Federation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Hartal, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 2, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

May 2, 2012

Record last verified: 2012-05

Locations