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

NCT01235000 | Unknown

• 1 other identifier: CIHR 200903CVC-203708/99971a
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• The seroprotection rate for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses

  The seroprotection rate based on hemagglutination inhibition (HI) assay for B/Brisbane/60/2008(Victoria)-like and B/Florida/4/06(Yamagata)-like viruses following a single age-appropriate dose of 2010-11 TIV containing B/Brisbane/60/2008(Victoria)-like virus in young children originally primed with two doses of 2008-09 TIV containing B/Florida/4/2006(Yamagata) and who had received a single dose of the 2009-10 TIV containing B/Brisbane/60/2008(Victoria) virus

  4-6 weeks following a single dose of 2010-11 trivalent inactivated influenza vaccine (TIV)

Secondary Outcomes (1)

• Antibody response to other relevant TIV components

  4-6 weeks following a single dose of 2010-11 TIV

Study Arms (1)

2010-11 influenza vaccine recipients

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

Biological: 2010-11 trivalent inactivated influenza vaccine

Interventions

2010-11 trivalent inactivated influenza vaccine BIOLOGICAL

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

2010-11 influenza vaccine recipients

Eligibility Criteria

• Age: 29 Months - 51 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants of an earlier clinical trial (TITRE I); enrolled in winter 2008/09 as previously unimmunized infants and toddlers (6-23 months of age) who later participated in 2009-10 study (TITRE II) to receive 2009-10 influenza vaccine

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Centre for Disease Control: lead

Study Sites (3)

BC Centre for Disease Control

Vancouver, British Columbia, V5Z 4R4, Canada

Location

McGill University Health Centre - Vaccine Study Centre

Montreal, Quebec, Canada

Location

Université Laval - Unité de recherche en santé publique

Québec, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 21857263 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Danuta M Skowronski, MD

  BC Centre for Disease Control, Vancouver, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: October 1, 2010
• Last Updated: November 5, 2010

Record last verified: 2010-11

Locations

CA (3)