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NCT00139113 · ClinicalTrials.gov registry record · Phase 4

Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children

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

Completed
Registry status
Phase 4
Development phase
248
Enrollment target

NCT00139113 is a Phase 4 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 248 participants.

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The verdict

NCT00139113, a Phase 4 study, has completed, sponsored by Centers for Disease Control and Prevention.

COMPLETED
Registry status
Phase 4
Development phase
248 participants
Enrollment target

Study Summary

Infants born to immune mothers and therefore having passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules. We found that when vaccination is begun at or after 12 months of age, there was no difference in the immune response to the vaccine between infants born to immune vs. susceptible mothers.

Interventions

  • BIOLOGICAL hepatitis A vaccine

Trial Details

FieldValue
Enrollment Target 248 participants
Start Date 1996-09
Est. Completion 2001-06
Phase Phase 4

What the Registry Record Tells You About NCT00139113

The ClinicalTrials.gov registry entry for NCT00139113 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 248 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 hepatitis A vaccine is the first listed.

NCT00139113 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00139113 about?

NCT00139113 is a clinical study titled "Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children". Infants born to immune mothers and therefore having passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedu...

What is the current status of trial NCT00139113?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 248 participants. The study started on 1996-09. Estimated completion is 2001-06.

What interventions are being tested in trial NCT00139113?

The interventions under investigation include: hepatitis A vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00139113?

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.