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NCT00153556 · ClinicalTrials.gov registry record · Phase 4

Study to Eliminate Hib Carriage in Rural Alaska Native Villages

A Phase 4 study, sponsored by Centers for Disease Control and Prevention.

Completed
Registry status
Phase 4
Development phase
3,200
Enrollment target

NCT00153556 is a Phase 4 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 3,200 participants.

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The verdict

NCT00153556, a Phase 4 study, has completed, sponsored by Centers for Disease Control and Prevention.

COMPLETED
Registry status
Phase 4
Development phase
3,200 participants
Enrollment target

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.

Interventions

  • BIOLOGICAL Hib conjugate vaccine (HbOC, Wyeth Vaccines)

Trial Details

FieldValue
Enrollment Target 3,200 participants
Start Date 2001-09
Est. Completion 2003-11
Phase Phase 4

What the Registry Record Tells You About NCT00153556

The ClinicalTrials.gov registry entry for NCT00153556 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 3,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Hib conjugate vaccine (HbOC, Wyeth Vaccines) is the first listed.

NCT00153556 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00153556 about?

NCT00153556 is a clinical study titled "Study to Eliminate Hib Carriage in Rural Alaska Native Villages". 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 ...

What is the current status of trial NCT00153556?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 3,200 participants. The study started on 2001-09. Estimated completion is 2003-11.

What interventions are being tested in trial NCT00153556?

The interventions under investigation include: Hib conjugate vaccine (HbOC, Wyeth Vaccines) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00153556?

This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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