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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: Completed Phase 4 study, sponsored by Centers for Disease Control and Prevention.
NCT00139113 is a Phase 4 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 248 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sera obtained at time of first hepatitis A vaccine dose (baseline) and 1, 7, and 12 months thereafter
Interventions
- BIOLOGICAL hepatitis A vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 1996-09 |
| Est. Completion | 2001-06 |
| Phase | Phase 4 |
What the finished NCT00139113 record still lists
NCT00139113 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which hepatitis A vaccine is the first listed.
NCT00139113 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00139113's enrollment target sits among peer trials
248 353rd of 2000 higher than 1,646 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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