TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost

NCT ID: NCT01235000

Last Updated: 2010-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31

Brief Summary

Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" & "A/H3N2") and two kinds of influenza B ("B/Yamagata" & "B/Victoria") can cause illness. The yearly influenza vaccine is designed to protect against both kinds of influenza A but only one or the other kind of influenza B. Current recommendations in Canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. In a previous study conducted in early 2010 we measured the antibody response to influenza B in children who had previously received two doses of a B/Yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness especially of children, understanding how to best protect children against both kinds of influenza B is important.

Conditions

Influenza

Keywords

Influenza vaccines; Infant; Dose-Response relationship, immunologic; Prime-boost response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

2010-11 influenza vaccine recipients

Participants of an earlier clinical trial (TITRE II) to evaluate prime-boost response across B lineages in 2009-10

2010-11 trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

A single age-appropriate dose of 2010-11 trivalent inactivated influenza vaccine

Interventions

2010-11 trivalent inactivated influenza vaccine

A single age-appropriate dose of 2010-11 trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Child previously participated in the TITRE II study;
• Child is healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination;
• 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 2010-11 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.

• Minimum Eligible Age: 29 Months
• Maximum Eligible Age: 51 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

British Columbia Centre for Disease Control

OTHER_GOV

Sponsor Role: lead

Responsible Party

BC Centre for Disease Control

Principal Investigators

Danuta M Skowronski, MD

Role: PRINCIPAL_INVESTIGATOR

BC Centre for Disease Control, Vancouver, Canada

Locations

BC Centre for Disease Control

Vancouver, British Columbia, Canada

McGill University Health Centre - Vaccine Study Centre

Montreal, Quebec, Canada

Université Laval - Unité de recherche en santé publique

Québec, Quebec, Canada

Countries

Canada

References

Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.

Reference Type: DERIVED

PMID: 21857263 (View on PubMed)

Other Identifiers

CIHR 200903CVC-203708/99971a

Identifier Type: -

Identifier Source: org_study_id