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

Influenza Clinical Trial

— TITRE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710866
• Other study ID #: PHAC 6273-15-2008/4160872
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2008
• Last updated: July 11, 2011
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2011
• Source: British Columbia Centre for Disease Control
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 23 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
Canada	Dalhousie University / IWK Health Centre	Halifax	Nova Scotia
Canada	McGill University Health Centre - Vaccine Study Centre	Montreal	Quebec
Canada	Université de Laval - Unité de recherche en santé publique	Québec	Quebec
Canada	Vaccine Evaluation Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Centre for Disease Control

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)	Seroprotection rate: HI titers =>40	27-46 days after the second dose	No
Primary	Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)	Seroprotection rate: HI titers =>40	27-46 days after the second dose	No
Primary	Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)	Seroprotection rate: HI titers =>40	27-46 days after the second dose	No
Primary	Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)	Seroprotection rate: HI titers =>40	27-46 days after the second dose	No
Primary	Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)		27-46 days after the second dose	No
Primary	Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)	Seroprotection rate: HI titers =>40	27-46 days after the second dose	No
Primary	Adverse Events: Fever After Either Dose - Infants 6-11 Months	Fever defined as temperature >= 38 C	3 days after immunization	Yes
Primary	Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-	Fever defined as temperature >= 38 C	3 days after immunization	Yes