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NCT00946101 · ClinicalTrials.gov registry record · Phase 4

A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age

A Phase 4 study of Influenza, sponsored by MedImmune.

Completed
Registry status
Phase 4
Development phase
326
Enrollment target
16
Study locations

NCT00946101 is a Phase 4 study of Influenza that has completed, run by MedImmune. The registered enrollment target is 326 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 16 study locations across 11 states.

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The verdict

NCT00946101, a Phase 4 study of Influenza, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 4
Development phase
326 participants
Enrollment target
16
Study locations

Study Summary

The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy children.

Conditions Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]

Study Locations (16)

California

  • Benchmark Research - Sacramento
  • California Research Foundation - San Diego
  • Benchmark Research - San Francisco

Texas

  • Benchmark Research - Austin
  • Benchmark Research Ft. Worth - Fort Worth
  • Benchmark Research San Angelo - San Angelo

Kentucky

  • Kentucky Pediatric Research Center - Bardstown
  • Central Kentucky Research Associates, Inc. - Lexington

Alabama

  • Coastal Clinic Research, Inc. - Mobile

Missouri

  • Sundance Clinical Research - St Louis

Nebraska

  • Meridian Clinical Research - Omaha

Nevada

  • Clinical Research Center of Nevada - Henderson

New York

  • Rochester Clinical Research Inc. - Rochester

Trial Details

FieldValue
Enrollment Target 326 participants
Start Date 2009-08
Est. Completion 2010-03
Phase Phase 4

Sponsor

MedImmune

210 total trials

What the Registry Record Tells You About NCT00946101

The ClinicalTrials.gov registry entry for NCT00946101 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00946101 reports 16 study locations spanning 11 distinct geographic areas - top geographies include California, Texas, Kentucky.

Frequently Asked Questions

What is clinical trial NCT00946101 about?

NCT00946101 is a clinical study titled "A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age". The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy children.

What is the current status of trial NCT00946101?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 326 participants. The study started on 2009-08. Estimated completion is 2010-03.

What conditions does trial NCT00946101 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00946101?

The interventions under investigation include: Placebo (BIOLOGICAL), MEDI3414 [Influenza A(H1N1) live attenuated, intranasal] (BIOLOGICAL).

Who is sponsoring clinical trial NCT00946101?

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

Where is trial NCT00946101 being conducted?

This trial has 16 study locations across Alabama, California, Kentucky, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Influenza

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.