CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 262 enrolled
Drug / intervention
Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)biological
Likely dose
Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00710866
NCT00710866Phase 3Completed
CompareCT.gov

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

British Columbia Centre for Disease Control·interventional·Posted Jul 8, 2008·Updated Aug 4, 2011

In Brief

A Phase 3 clinical trial evaluating Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) for Influenza. Completed, enrolled 262 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 8, 2008
Enrollment StartAug 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.0 years ago

Interventions

Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)biological

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.