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Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants

NCT00192335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 890

Last updated 2007-11-27

No results posted yet for this study

Summary

* Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist
* Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist

Conditions

  • Healthy

Interventions

BIOLOGICAL

CAIV-T

BIOLOGICAL

CAIVT

The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

BIOLOGICAL

FluMist

The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Luis Angles, MD · Heart of America Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Completion
2005-02-28

Countries

  • United States

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 NCT00192335 on ClinicalTrials.gov