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

July 11, 2011 updated by: British Columbia Centre for Disease Control
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3C 4J2
      • Vancouver, British Columbia, Canada
        • Vaccine Evaluation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Dalhousie University / IWK Health Centre
    • Quebec
      • Montreal, Quebec, Canada, H9H4Y6
        • McGill University Health Centre - Vaccine Study Centre
      • Québec, Quebec, Canada
        • Université de Laval - Unité de recherche en santé publique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination
  • Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)
  • Child is available and can complete all relevant procedures during the entire study period
  • Parent or legal guardian is available and can be reached by phone during the entire study period
  • Parent/guardian provides written informed consent
  • Parent/guardian is fluent in English

Exclusion Criteria:

  • Child has history of laboratory-confirmed influenza
  • Child has history of any prior influenza immunization
  • Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)
  • Child has received immune globulin or other blood products within the prior six weeks
  • Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed)
  • Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy)
  • Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period
  • Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period
  • Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
2 doses 0.5mL VAXIGRIP® at months 0, 1
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.
Other Names:
  • VAXIGRIP®
Active Comparator: 2
2 doses 0.25mL VAXIGRIP® at months 0, 1
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.
Other Names:
  • VAXIGRIP®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)
Time Frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
27-46 days after the second dose
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)
Time Frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
27-46 days after the second dose
Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)
Time Frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
27-46 days after the second dose
Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)
Time Frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
27-46 days after the second dose
Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)
Time Frame: 27-46 days after the second dose
27-46 days after the second dose
Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)
Time Frame: 27-46 days after the second dose
Seroprotection rate: HI titers =>40
27-46 days after the second dose
Adverse Events: Fever After Either Dose - Infants 6-11 Months
Time Frame: 3 days after immunization
Fever defined as temperature >= 38 C
3 days after immunization
Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-
Time Frame: 3 days after immunization
Fever defined as temperature >= 38 C
3 days after immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Centre for Disease Control

Investigators

  • Principal Investigator: Danuta M Skowronski, MD, BC Centre for Disease Control

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAC 6273-15-2008/4160872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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