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

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ClinicalTrials.gov Identifier: NCT00710866
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
British Columbia Centre for Disease Control

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : August 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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 Name: 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 Name: VAXIGRIP®



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata) [ Time Frame: 27-46 days after the second dose ]
  6. 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

  7. Adverse Events: Fever After Either Dose - Infants 6-11 Months [ Time Frame: 3 days after immunization ]
    Fever defined as temperature >= 38 C

  8. Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)- [ Time Frame: 3 days after immunization ]
    Fever defined as temperature >= 38 C



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Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710866


Locations
Canada, British Columbia
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Danuta M. Skowronski, BC Centre for Disease Control
ClinicalTrials.gov Identifier: NCT00710866     History of Changes
Other Study ID Numbers: PHAC 6273-15-2008/4160872
First Posted: July 8, 2008    Key Record Dates
Results First Posted: August 4, 2011
Last Update Posted: August 4, 2011
Last Verified: July 2011

Keywords provided by British Columbia Centre for Disease Control:
Influenza Vaccines
Infant
Dose-Response Relationship, Immunologic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs