Are you interested in receiving an experimental vaccine against E. Coli?
This clinical research study is looking at the safety and effectiveness of a vaccine for E. coli, a bacteria that normally lives in the intestines of healthy people and animals. Most types of E. coli are harmless or cause relatively brief diarrhea. But a few strains, such as E. coli O157:H7, can cause severe stomach cramps, bloody diarrhea and vomiting.
The purpose of this study is to show that a high-dose seasonal influenza vaccine given together with an Escherichia coli vaccine does not induce lower antibody response against each of the 4 influenza vaccine strains.
Would you like to take part?
As a volunteer in a research study, you will receive study-related medical care from the study doctor and regular follow up of your condition to monitor the effectiveness of the care you will receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to other Canadians, and whether it will be made widely available in Canada. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are medically stable at the time of vaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy during the 6 weeks before enrollment and when hospitalization for worsening of the disease is not anticipated. Participants will be included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination.
- Are age 65 years or older
- Are: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- Are willing and able to adhere to the lifestyle restrictions specified in this protocol.
- Agree to not donate blood from the time of vaccination until 3 months after receiving the last dose of study vaccine
You may not qualify to participate in this study if you:
- Have a history of an underlying clinically significant acute or uncontrolled chronic medical condition or significant cognitive impairment or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Have a known or suspected allergy or history of severe allergic reaction, anaphylaxis, or other serious adverse reactions to vaccines or vaccine excipients.
- Have a history of severe allergic reactions (for example anaphylaxis) to any component of the high-dose (HD) quadrivalent seasonal influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
- Have a history of acute polyneuropathy (for example, Guillain-Barré syndrome) or chronic inflammatory demyelinating polyneuropathy
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.