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Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children

NCT00192270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2012-03-06

No results posted yet for this study

Summary

The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.

Conditions

  • Healthy

Interventions

BIOLOGICAL

CAIV-T

Each dose of the vaccine was formulated to contain approximately 1 x 10\^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of \~3 x 10\^7 TCID50 per dose.

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Raburn Mallory, MD · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2001-01-31
Completion
2001-01-31

Countries

  • Belgium
  • Finland

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 NCT00192270 on ClinicalTrials.gov