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

NCT00710866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2011-08-04

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • British Columbia Centre for Disease Control

    lead OTHER_GOV

Principal Investigators

  • Danuta M Skowronski, MD · BC Centre for Disease Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00710866 on ClinicalTrials.gov