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NCT00133536 · ClinicalTrials.gov registry record · Phase 1
A/H5N1 Vaccine in Healthy Children Aged 2-9 Years
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 157
- Enrollment target
NCT00133536 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 157 participants.
The verdict
NCT00133536, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 157 participants
- Enrollment target
Study Summary
The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts to the vaccine. To look at the side effects, researchers will follow children closely after vaccination. To look at immune system responses, researchers will test the children's blood before and a number of times after vaccination. Participants will include up to 130 healthy children ages 2-9 years. Participants will be assigned to receive 2, up to 3 doses of vaccine, or placebo (inactive substance). Subjects will receive at least 2 doses of vaccine approximately 28 days apart. If data shows an enhanced immune response from a third vaccination, children will be offered a third dose of the vaccine. Participants will be involved in study related procedures for up to 13 months, including up to 6 study visits, plus a number of telephone calls.
Interventions
- DRUG Placebo
- BIOLOGICAL Influenza A/H5N1 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133536
The ClinicalTrials.gov registry entry for NCT00133536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00133536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00133536 about?
NCT00133536 is a clinical study titled "A/H5N1 Vaccine in Healthy Children Aged 2-9 Years". The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts to the vaccine. To look at the side effects, researchers will follow children closely after vaccinat...
What is the current status of trial NCT00133536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 157 participants. The study started on 2006-01. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00133536?
The interventions under investigation include: Placebo (DRUG), Influenza A/H5N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00133536?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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