Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity (TITRE)
This study has been completed.
Sponsor:
British Columbia Centre for Disease Control
Information provided by:
British Columbia Centre for Disease Control
ClinicalTrials.gov Identifier:
NCT00710866
First received: July 7, 2008
Last updated: July 11, 2011
Last verified: July 2011
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by British Columbia Centre for Disease Control:
Primary Outcome Measures:
- Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1) [ Time Frame: 27-46 days after the second dose ] [ Designated as safety issue: No ]Seroprotection rate: HI titers =>40
- Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1) [ Time Frame: 27-46 days after the second dose ] [ Designated as safety issue: No ]Seroprotection rate: HI titers =>40
- Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2) [ Time Frame: 27-46 days after the second dose ] [ Designated as safety issue: No ]Seroprotection rate: HI titers =>40
- Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2) [ Time Frame: 27-46 days after the second dose ] [ Designated as safety issue: No ]Seroprotection rate: HI titers =>40
- Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata) [ Time Frame: 27-46 days after the second dose ] [ Designated as safety issue: No ]
- Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata) [ Time Frame: 27-46 days after the second dose ] [ Designated as safety issue: No ]Seroprotection rate: HI titers =>40
- Adverse Events: Fever After Either Dose - Infants 6-11 Months [ Time Frame: 3 days after immunization ] [ Designated as safety issue: Yes ]Fever defined as temperature >= 38 C
- Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)- [ Time Frame: 3 days after immunization ] [ Designated as safety issue: Yes ]Fever defined as temperature >= 38 C
| Enrollment: | 262 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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®
|
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
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 |
More Information
No publications provided by British Columbia Centre for Disease Control
Additional 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 |
| Study First Received: | July 7, 2008 |
| Results First Received: | July 11, 2011 |
| Last Updated: | July 11, 2011 |
| Health Authority: | Canada: Health Canada |
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 |
ClinicalTrials.gov processed this record on May 19, 2013