Clinical trial NCT01000831: Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: vaccine
influenza
H1N1 influenza vaccine
influenza vaccine
Arepanrix
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: PHAC/CIHR Influenza Research Network
First posted: 2009-10-23
Enrollment: 167
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 weeks.

Detailed description: The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.

The objectives of this study are two-fold:

1. To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.
2. To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.

Eligibility criteria: Inclusion Criteria:

* Written informed consent provided for the subject by a parent or legal guardian
* Children age 6-35 months

Exclusion Criteria:

* Allergies to eggs, thimerosal, gentamicin sulphate or latex
* Life-threatening reaction to previous Flu vaccine
* Bleeding disorder
* Pregnancy
* Receipt of blood or blood products in past 3 months
* Chronic illness that could interfere with trial participation
* Compromised immune system
* Previous lab-confirmed H1N12009 infection
* Receipt of H1N12009 vaccine
* Receipt of Seasonal Influenza vaccine since March 2009

Primary outcomes:
measure: Safety and immunogenicity of one and two doses Arepanrix
timeFrame: Day 7 and Day 21 post vaccination measured at day 42
measure: Rapid Trial
timeFrame: Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital, University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Child and Family Research Institute
state: British Columbia
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center, University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology, Dalhousie University
state: Nova Scotia
city: Montreal
country: Canada
facility: McGill University Health Center - Vaccine Study Center
state: Quebec
city: Quebec City
country: Canada
facility: Unité de Recherche en Santé Publique (CHUQ)
state: Quebec
Study officials:
affiliation: University of British Columbia
name: David Scheifele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Recherche en Santé Publique (CHUQ)
name: Marc Dionne, MD
role: STUDY_DIRECTOR
affiliation: McGill University Health Center - Vaccine Study Center
name: Brian Ward, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Center for Vaccinology, Dalhousie University
name: Joanne Langley, MD
role: STUDY_DIRECTOR
affiliation: Alberta Children's Hospital, University of Calgary
name: Otto Vanderkooi, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Simon Dobson, MD
role: STUDY_DIRECTOR
References:
citation: Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Rapid Trials Investigators. Evaluation of adjuvanted pandemic H1N1(2009) influenza vaccine after one and two doses in young children. Pediatr Infect Dis J. 2011 May;30(5):402-7. doi: 10.1097/INF.0b013e3182068f33.