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NCT00402649 · ClinicalTrials.gov registry record · Phase 1
Open-Label Study of H5 Vaccine in Participants of Protocol 04-077
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00402649 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 35 participants.
The verdict
NCT00402649, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and received a placebo injection instead of the flu vaccine or were incompletely immunized. The study has 2 purposes: to make sure there are no serious side effects in children and to see how the immune systems react to the vaccine. Study procedures include up to 4 study visits, up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card to record side effects, temperatures, and medications. Parents will have the option for the child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require a 6-month visit and participation for an additional 6 months.
Interventions
- BIOLOGICAL Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-02 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00402649
The ClinicalTrials.gov registry entry for NCT00402649 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 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 1 intervention - of which Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) is the first listed.
NCT00402649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00402649 about?
NCT00402649 is a clinical study titled "Open-Label Study of H5 Vaccine in Participants of Protocol 04-077". This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and received a placebo injection ...
What is the current status of trial NCT00402649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2007-02. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00402649?
The interventions under investigation include: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00402649?
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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