NCT00710866

Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: British Columbia Centre for Disease Control · Other Government
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)	Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-07-08
• Last updated: 2011-08-04
• Results posted: 2011-08-04

Locations

5 sites across 1 country: Canada