Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine

Influenza Clinical Trial

Official title:

PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000584
• Other study ID #: H09-02811
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2009
• Last updated: April 8, 2015
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• H1N1 2009 Influenza
• Influenza
• Influenza, Human

Intervention

Biological:
• Arepanrix, Vaxigrip 2009/2010
Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently
• Arepanrix, Vaxigrip 2009/2010
Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Kingston, Frontenac, Lanark Health Unit	Kingston	Ontario
Canada	Institut national de sante publique du Quebec	Quebec City	Quebec
Canada	University of Toronto, Mt Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
David Scheifele	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events (AEs) for days 0-6 after each vaccination		Day 7 and Day 21 post vaccination	Yes
Primary	Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination		Day 7 and Day 21 post vaccination	Yes
Secondary	Immunogenicity: Comparison of baseline and post-immunization antibody titres		Day 21 post vaccination	No