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NCT00344305 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
A Phase 2 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT00344305: Completed Phase 2 study, sponsored by MedImmune.
NCT00344305 is a Phase 2 study that has completed, run by MedImmune. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00344305, a Phase 2 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.
Primary Outcome
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sam
Interventions
- BIOLOGICAL Trivalent influenza virus vaccine live, intranasal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2006-05-01 |
| Est. Completion | 2006-12-01 |
| Phase | Phase 2 |
What the finished NCT00344305 record still lists
NCT00344305 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 1 intervention - of which Trivalent influenza virus vaccine live, intranasal is the first listed.
NCT00344305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00344305 about?
NCT00344305 is a clinical study titled "A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children". Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.
What is the current status of trial NCT00344305?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2006-05-01. Estimated completion is 2006-12-01.
What interventions are being tested in trial NCT00344305?
The interventions under investigation include: Trivalent influenza virus vaccine live, intranasal (BIOLOGICAL).
Who is sponsoring clinical trial NCT00344305?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00344305's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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