TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B (TITRE II)
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ClinicalTrials.gov Identifier: NCT01067404 |
Recruitment Status
: Unknown
Verified February 2010 by British Columbia Centre for Disease Control.
Recruitment status was: Enrolling by invitation
First Posted
: February 11, 2010
Last Update Posted
: February 11, 2010
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Condition or disease | Intervention/treatment |
---|---|
Influenza | Biological: Trivalent inactivated influenza vaccine |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B |
Study Start Date : | February 2010 |

Group/Cohort | Intervention/treatment |
---|---|
2008-09 study TIV recipients
Infants and toddlers who participated in earlier clinical trial (TITRE) to evaluate dosing (0.25mL versus 0.5mL) of trivalent influenza vaccine (TIV)
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Biological: Trivalent inactivated influenza vaccine
0.25mL dose of 2009-10 trivalent inactivated influenza vaccine (TIV)
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- Immunogenicity based on CPMP criteria (seroprotection, defined as reciprocal HI titre equal to/greater than 40; seroconversion rate and factor) for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses [ Time Frame: 4-6 weeks after receipt of TIV ]

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Ages Eligible for Study: | 18 Months to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Child previously participated in the TITRE I study;
- Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
- Child has received the 2009 pandemic H1N1 influenza vaccine;
- Child is available and can complete all relevant procedures during the study period;
- Parent or legal guardian is available and can be reached by phone during the study period;
- Parent/guardian provides written informed consent;
- And, parent/guardian is fluent in English/French.
Exclusion Criteria:
- Child has already received the 2009-10 seasonal (TIV) influenza vaccine;
- Child has received immune globulin or other blood products within the prior six weeks;
- Child has received injected or oral steroids within prior six weeks;
- Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period;
- Or, child has a recently acquired health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child.

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): NCT01067404
Canada, British Columbia | |
BC Centre for Disease Control | |
Vancouver, British Columbia, Canada, V5Z4R4 | |
Canada, Quebec | |
McGill University Health Centre - Vaccine Study Centre | |
Montreal, Quebec, Canada | |
Université Laval - Unité de recherche en santé publique | |
Québec, Quebec, Canada |
Principal Investigator: | Danuta M Skowronski, MD | BC Centre for Disease Control, Vancouver, Canada |
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: | NCT01067404 History of Changes |
Other Study ID Numbers: |
CIHR 200903CVC-203708/99971 |
First Posted: | February 11, 2010 Key Record Dates |
Last Update Posted: | February 11, 2010 |
Last Verified: | February 2010 |
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 |