Clinical trial NCT01000584: Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
H1N1 2009 Influenza
Keywords: vaccine
H1N1
influenza
H1N1 influenza vaccine
influenza vaccine
seasonal Influenza
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-10-23
Enrollment: 309
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.

Detailed description: The objectives of this study are two-fold:

1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes available so as to inform the subsequent use of vaccine in public programs.
2. To evaluate the compatibility of co-administered H1N12009 pandemic vaccine and seasonal TIV vaccine in the same group of subjects, as the option of co-administration would be useful for public programs.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Adults 20-59 years of age

Exclusion Criteria:

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

Primary outcomes:
measure: Occurrence of adverse events (AEs) for days 0-6 after each vaccination
timeFrame: Day 7 and Day 21 post vaccination
measure: Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination
timeFrame: Day 7 and Day 21 post vaccination
Secondary outcomes:
measure: Immunogenicity: Comparison of baseline and post-immunization antibody titres
timeFrame: Day 21 post vaccination
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston, Frontenac, Lanark Health Unit
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto, Mt Sinai Hospital
state: Ontario
city: Quebec City
country: Canada
facility: Institut national de sante publique du Quebec
state: Quebec
Study officials:
affiliation: University of British Columbia
name: David Scheifele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, Mt Sinai Hospital
name: Allison McGeer, MD
role: STUDY_DIRECTOR
affiliation: McMaster University
name: Mark Loeb, MD
role: STUDY_DIRECTOR
affiliation: Kingston, Frontenac, Lanark Health Unit
name: Ian Gemmill, MD
role: STUDY_DIRECTOR
affiliation: Institut national de sante publique du Quebec
name: Marc Dionne, MD
role: STUDY_DIRECTOR
References:
citation: Scheifele DW, Ward BJ, Dionne M, Vanderkooi OG, Loeb M, Coleman BL, Li Y; PHAC/CIHR Influenza Research Network (PCIRN). Compatibility of ASO3-adjuvanted H1N1pdm09 and seasonal trivalent influenza vaccines in adults: results of a randomized, controlled trial. Vaccine. 2012 Jul 6;30(32):4728-32. doi: 10.1016/j.vaccine.2012.05.029. Epub 2012 May 28.