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

NCT00946101 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2011-08-11

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

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

0.5 mL: (intranasal sprayer)

BIOLOGICAL

Placebo

Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer

Sponsors & Collaborators

Principal Investigators

  • Elissa Malkin, D.O. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00946101 on ClinicalTrials.gov