NCT00224783

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

Placebo-controlled Double-blind Controlled Trial of Single Intranasal Inoculation of CAIV-T Liquid Formulation in Healthy Japanese Male Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults by evaluating the incidence of influenza-like symptoms, and the type, incidence, and severity of adverse events.

Conditions

• Healthy Japanese Male Adults

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2002-08-01
• Completion: 2002-09-01
• First posted: 2005-09-23
• Last updated: 2012-01-26