Public Health Agency of Canada -
Influenza Vaccine Safety and Immunogenicity Surveillance Studies

• Study objectives
• Description of the research
• Potential harms, injuries, discomforts or invonvenience
• Potential benefits
• Confidentiality
• Protocols and forms for study

» Study Objectives

The purpose of this study is to develop a system that allows the Public Health Agency of Canada to rapidly collect detailed information on common side effects of influenza vaccination, and on the immune response to vaccination. This will help to ensure the safety of each annual vaccine. More importantly, it will facilitate rapid safety and efficacy testing of vaccines developed to protect Canadians during the next influenza pandemic.

» Description of the research

Adults (aged >18 years and older) who are planning to get their influenza vaccine this year are being asked to participate in this study. People with some types of chronic illnesses cannot participate: if you are interested in the study, you will be asked about these illnesses before the study starts. If you agree to participate you will be asked to:

• Remain for 30 minutes after vaccination to learn how to complete study forms, and to have the injection site inspected at the end of the 30 minute period
• For 7 days after vaccination, on a daily basis: take your temperature once a day, measure the size of any redness, swelling, hardness or bruising at the place on your arm where you were vaccinated, and complete a diary card about how you are feeling
• For 21 days after vaccination, keep track of how you are feeling, and write down the timing and description of any illness
• Talk, in person, or by telephone, to study nurses on day 4, 8 and 22 after vaccination about your symptoms, temperature, etc. These interviews/telephone calls will take 5 to 30 minutes depending on how you have been feeling
• Keep a diary of all medications you take for 21 days after you get your vaccine. If you have any illness, this information is needed to help study staff determine whether the illness is from the vaccine or not
• Return, by mail, or in person, your study diaries to the study nurses at the end of the study

If you agree to participate in this study, you will be asked whether you are willing to participate in an optional part B of the study. If you agree to participate in part B, you will be asked to have two blood specimens taken, one before you get the vaccine, and one 21 days later. Each one will be a maximum volume of 20 mls (about 4 teaspoons).

» Potential harms, injuries, discomforts or invonvenience

There are no known harms associated with participation in part A of this study. It will take you some time to track your symptoms, temperature and medication use, and to talk to study staff about these on days 4, 8 and 22 after vaccination. If you agree to participate in part B of the study, you may have bruising, swelling and/or pain at the place the blood is drawn. There may also be a very small chance of getting an infection from having the blood sample taken.

» Potential benefits

There are no direct benefits from participating in this study. The information from this study may benefit public health by providing more information about vaccine side effects, and by testing a system for tracking vaccine safety in the future.

» Confidentiality

Confidentiality will be respected and no information that discloses your identity will be released or published without consent unless required by law. This legal obligation includes a number of circumstances, such as suspected communicable diseases or recording of plans to commit suicide, or where research documents are ordered to be produced by a court of law or where researchers are obliged to report to the appropriate authorities. If you have a serious adverse event after your vaccination, the study will be required to report it to public health authorities.

Your diary will be kept at the individual study sites and all source documents, consent forms and any other study related materials, will be kept in a secured storage area for 5 years and then destroyed. Data from the study, with all personal identifiers removed, will be sent to and maintained at the Public Health Agency of Canada for 15 years and then destroyed.

» Protocols and forms for study

Please note that the documents below are in pdf format, and will require the installation of the free Adobe Reader, if you do not have it already installed on your computer.

• Postmarketing Surveillance of Annual Influenza Vaccines: Extended Vaccine Safety
• Postmarketing Surveillance of Annual Influenza Vaccines: Immunogenicity Annex
• Subject Consent Form
• Study Site Daily Report on Study Progress and Key Findings
• Subject Enrollment and Day 0 Observations Form 2007
• Subject Diary Card for Days 0 - 7
• Unsolicited Adverse Event Report Card: Days 8 to 21
• Subject NEW Medication Log