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

Phase 4

Completed

• Conditions: Influenza; H1N1 2009 Influenza
• Interventions: Biological: Arepanrix, Vaxigrip 2009/2010

• Registration Number: NCT01000584
• Lead Sponsor: David Scheifele

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.

Study Timeline

• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2009-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Arepanrix, Vaxigrip 2009/2010	Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently
2	Arepanrix, Vaxigrip 2009/2010	Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine

Primary Outcome Measures

Name	Time	Method
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
Occurrence of adverse events (AEs) for days 0-6 after each vaccination	Day 7 and Day 21 post vaccination

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: Comparison of baseline and post-immunization antibody titres	Day 21 post vaccination

Trial Locations

Locations (4)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Kingston, Frontenac, Lanark Health Unit; 🇨🇦 Kingston, Ontario, Canada

University of Toronto, Mt Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Institut national de sante publique du Quebec; 🇨🇦 Quebec City, Quebec, Canada