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

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

This study is not yet open for participant recruitment.

Verified by British Columbia Centre for Disease Control, July 2008

First Received: July 7, 2008 No Changes Posted

Sponsored by:	British Columbia Centre for Disease Control
Information provided by:	British Columbia Centre for Disease Control
ClinicalTrials.gov Identifier:	NCT00710866

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by British Columbia Centre for Disease Control:

Primary Outcome Measures:

Immunogenicity -- based on standard CPMP criteria (seroprotection, defined as reciprocal hemagglutination inhibition (HI) titre ≥ 40; seroconversion rate and factor, defined based on fold-rise above baseline) [ Time Frame: 4-6 weeks after the second dose of TIV (trivalent inactivated influenza vaccine) ] [ Designated as safety issue: No ]
Reactogenicity -- local and systemic, including serious adverse events (SAEs) [ Time Frame: Local/systemic within one week of immunization; SAEs throughout study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	August 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2 doses 0.5mL VAXIGRIP® at months 0, 1	Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)
2: Active Comparator 2 doses 0.25mL VAXIGRIP® at months 0, 1	Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)

Eligibility

Ages Eligible for Study:	6 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710866

Contacts

Contact: Danuta M Skowronski, MD	604-660-6067	danuta.skowronski@bccdc.ca
Contact: Travis Hottes, MSc	604-660-4981	travis.hottes@bccdc.ca

Locations

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

Sponsors and Collaborators

British Columbia Centre for Disease Control

Investigators

Principal Investigator:

Danuta M Skowronski, MD

BC Centre for Disease Control

More Information

No publications provided

Responsible Party:	BC Centre for Disease Control ( Dr. Danuta M. Skowronski )
Study ID Numbers:	PHAC 6273-15-2008/4160872
Study First Received:	July 7, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00710866 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by British Columbia Centre for Disease Control:

Influenza Vaccines
Infant
Dose-Response Relationship, Immunologic

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009