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NCT00493285 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age

A Phase 1 study, sponsored by MedImmune.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target

NCT00493285: Completed Phase 1 study, sponsored by MedImmune.

NCT00493285 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00493285, a Phase 1 study, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target

Study Summary

The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.

Primary Outcome

The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.

Interventions

  • BIOLOGICAL MEDI-534

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2007-07
Est. Completion 2010-04
Phase Phase 1
MedImmune

210 total trials

What the finished NCT00493285 record still lists

NCT00493285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).

The record links to 0 conditions, and to 1 intervention - of which MEDI-534 is the first listed.

NCT00493285 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00493285 about?

NCT00493285 is a clinical study titled "Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age". The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.

What is the current status of trial NCT00493285?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2007-07. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00493285?

The interventions under investigation include: MEDI-534 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00493285?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00493285's enrollment target sits among peer trials

49 1017th of 2000 higher than 976 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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Source: ClinicalTrials.gov NCT00493285, the US trial registry maintained by the National Library of Medicine. NCT00493285 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.