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

Phase 4

Completed

• Conditions: Influenza; H1N1 2009 Influenza

• 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

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