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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.
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 |
What the finished NCT00402649 record still lists
NCT00402649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) is the first listed.
NCT00402649 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00402649's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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