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NCT Number: NCT01000584

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

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.

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Key information

Conditions

Influenza H1N1 2009 Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

The objectives of this study are two-fold:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arepanrix, Vaxigrip 2009/2010

Biological

Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently

Primary outcomes

  1. Occurrence of adverse events (AEs) for days 0-6 after each vaccination

    Time frame: Day 7 and Day 21 post vaccination

  2. Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination

    Time frame: Day 7 and Day 21 post vaccination

Secondary outcomes

  1. Immunogenicity: Comparison of baseline and post-immunization antibody titres

    Time frame: Day 21 post vaccination

Sponsors and collaborators

Lead sponsor

David Scheifele

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2009
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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