Clinical trial NCT01001325: Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?
Official title: A Randomized Controlled Trial of the Effect of Seasonal Influenza Vaccination on the Incidence of Infection Due to the 2009 H1N1 Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: influenza
vaccine
observer blind
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-10-26
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Since the onset of the 2009 pandemic, several observational public health investigations in Canada have identified evidence that suggests that adults, particularly younger adults, who have previously received seasonal influenza vaccine are at increased risk of infection with the 2009 pandemic strain of H1N1 (pH1N1). Investigations in Australia, the United States and the United Kingdom have not identified this effect. While it is not possible to have an answer to whether this affect is real prior to the second wave of the 2009 pandemic, it remains vital to future influenza vaccination programs that the hypothesis that, in 2009, seasonal vaccine increases or decreases the risk of pH1N1 infection be confirmed or refuted.

The objective of this study is to determine whether Ontario adults aged 18-60 years who receive the 2009 seasonal influenza vaccine will be at a 2 fold or greater increased risk of infection with influenza pH1N1 during the second or third wave of the 2009 pandemic.

Detailed description: This study will be an observer -blind randomized controlled trial.

This study will primarily recruit patients from an existing cohort of adult health care and other workers in Toronto, as of September 15, 2009, almost 1000 adults are participating in this cohort; with approximately 75 new cohort members being recruited weekly (target is 1300). Recruitment will be supplemented by enrollment at Hamilton Health Sciences Centre (N\~3920 employees plus physicians \& midwives) and Queen Elizabeth II Health Centre in Halifax (N\~6000 employees plus physicians \& midwives).

To date, health care workers in the Toronto cohort have been recruited at the Mount Sinai Hospital, Toronto East General Hospital, and North York General Hospital. Recruitment is just beginning at Sunnybrook Health Sciences Centre, and the University Health Network.

Non-health care workers are being recruited from several large Toronto employers of primarily office workers. These include the Ontario Agency for Health Protection and Promotion, the head offices of the Ontario Power Generation Corporation, the Art Gallery of Ontario, and the head offices of Scotia Bank. Non-health care workers should meet inclusion criteria and should not work primarily with children or from a home office.

Participants in the study are completing web-based diaries weekly, and, whenever they develop symptoms possibly compatible with influenza, are submitting nasal swabs, and completing symptom diaries daily while ill. Nasal swabs are tested by polymerase chain reaction (PCR) on a same or next day basis with antivirals prescribed to participants who develop influenza.

Eligibility criteria: Inclusion Criteria:

1. 18 to 60 years old, inclusive, as of September 1st, 2009;
2. understand the study, agree to its provisions, and give written informed consent prior to entry;
3. available for follow-up during the study period;
4. have convenient access to a computer with internet access and basic skills for use of the internet;

Exclusion Criteria:

1. planning to spend more than two consecutive weeks outside of Canada from October 1, 2009 to April 15th 2010.
2. received immunoglobulin within six months of study entry;
3. has already received a 2009 seasonal influenza vaccine (southern or northern hemisphere)
4. has had laboratory-confirmed infection with 2009 H1N1 influenza
5. is participating in a clinical trial that would result in the receipt of investigational medication during the study period;
6. allergic to eggs, to influenza vaccine, or any components of the seasonal influenza vaccine
7. has had a previous severe adverse event associated with an influenza vaccine
8. has a significant chronic underlying illness that would warrant seasonal influenza vaccine in a usual year, or is known to be pregnant.

Primary outcomes:
measure: Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab
timeFrame: day +7 post seasonal influenza vaccination (or placebo) to end of study
Secondary outcomes:
Other outcomes:
Locations:
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Allison J McGeer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Brenda L. Coleman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Agency for Health Protection & Promotion
name: Natasha Crowcroft, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Karen Green, MSc
role: STUDY_DIRECTOR
affiliation: North York General Hospital
name: Kevin Katz, MD
role: STUDY_DIRECTOR
affiliation: Hamilton Health Sciences Centre
name: Mark Loeb, MD
role: STUDY_DIRECTOR
affiliation: MOUNT SINAI HOSPITAL
name: Donald Low, MD
role: STUDY_DIRECTOR
affiliation: Queen Elizabeth II Health Sciences Centre
name: Shelly McNeil, MD
role: STUDY_DIRECTOR
affiliation: Unity Health Toronto
name: Matthew Muller, MD, PhD
role: STUDY_DIRECTOR
affiliation: Sunnybrook Health Sciences Centre
name: Andrew Simor, MD
role: STUDY_DIRECTOR
References: