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Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults

NCT00224783 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-01-26

No results posted yet for this study

Summary

The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults.

Conditions

  • Healthy Japanese Male Adults

Interventions

BIOLOGICAL

CAIV-T

Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T)

BIOLOGICAL

Placebo

0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).

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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-08-31
Completion
2002-09-30

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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 NCT00224783 on ClinicalTrials.gov