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Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Children

NCT00192244 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2006-10-03

No results posted yet for this study

Summary

\- The purpose of this study is to determine the efficacy of CAIV-T in a diverse Asian population aged from 6 months to less than 36 months, in tropical and temperate climates, against culture-confirmed influenza illness. In addition, the trial provides the opportunity to investigate the efficacy of CAIV-T over multiple influenza seasons, and to investigate the effect of CAIV-T on acute otitis media.

Conditions

  • Healthy

Interventions

BIOLOGICAL

CAIV-T, Liquid

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Robert Walker, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-09-30
Completion
2002-10-31

Countries

  • China

Study Locations

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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 NCT00192244 on ClinicalTrials.gov