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Study to Eliminate Hib Carriage in Rural Alaska Native Villages

NCT00153556 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3200

Last updated 2005-09-12

No results posted yet for this study

Summary

Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease has not been eliminated. This study is designed to test one possible means of eliminating Hib carriage and thus to eliminate person to person transmission and invasive disease.

The objective of this study is to evaluate the effectiveness of community-wide use of Hib conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.

Secondary objectives include:

* Determine risk factors for Hib OP carriage including demographic characteristics, and immunologic characteristics (antibody level and function). This will be accomplished through a case-control study described below.
* Measure antibody response to Hib conjugate vaccine among adults who have not previously received Hib vaccine. This will be accomplished through a cohort study of participating adults in the vaccine intervention communities.

Conditions

  • Haemophilus Influenzae Type B
  • Carrier State

Interventions

BIOLOGICAL

Hib conjugate vaccine (HbOC, Wyeth Vaccines)

Sponsors & Collaborators

  • CDC-Arctic Investigations Program

    collaborator UNKNOWN

  • Alaska Native Tribal Health Consortium

    collaborator OTHER

  • Yukon Kuskokwim Health Corporation

    collaborator OTHER

  • Alaska State Public Health Laboratories

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Centers for Disease Control and Prevention

    lead FED

Principal Investigators

  • Thomas W Hennessy, MD,MPH · Centers for Disease Control and Prevention-Arctic Investigations Program

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-30
Completion
2003-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00153556 on ClinicalTrials.gov