H1N1 Vaccine Safety in Manitoba, Canada

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by International Centre for Infectious Diseases, Canada.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
International Centre for Infectious Diseases, Canada
ClinicalTrials.gov Identifier:
NCT01421251
First received: August 19, 2011
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

Many people worldwide received the monovalent adjuvanted H1N1 vaccine. However, very little is known about the safety of the vaccine, particularly beyond the first few weeks after vaccination. This study will combine data from a well-established immunization registry in Manitoba with data from hospitalization and physician records, to examine the safety of the vaccine in the six month period post-vaccination. Studies on vaccine safety are important as the public's perception of the safety of a vaccine has a major role in its uptake.


Condition
H1N1 Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Safety of GSK Biological's H1N1 Pandemic Vaccine in Manitoba, Canada

Resource links provided by NLM:


Further study details as provided by International Centre for Infectious Diseases, Canada:

Primary Outcome Measures:
  • Adverse Effects of H1N1 vaccination [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Incidence rate ratios of certain vaccination adverse effects


Secondary Outcome Measures:
  • Incidence Ratios of Adverse Effects [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Standardized incidence ratios of certain adverse events in relation to history of H1N1 vaccination.

  • Sex-specific adverse effects of vaccination [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Determination of sex-specific adverse effects following H1N1 vaccination.


Biospecimen Retention:   None Retained

None collected


Estimated Enrollment: 800000
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Matched cohorts - population based
Two cohorts: vaccinated individuals are matched to unvaccinated individuals on the basis of age, sex, and postal code of residence.

Detailed Description:

The objective of this study is to examine the safety of the H1N1 vaccine administered in Manitoba during the second wave of the pandemic (Oct 2009-Mar 2010) by describing the age sex specific and age standardized incidence rates of certain vaccination adverse events in the vaccinated populations during the first 6 months of follow-up and to compare the rates with those in the non-vaccinated population and the general Manitoba population.

Study design The proposed study will be a retrospective analysis of population based cohorts of subjects whose vaccination status and health events before and after H1N1 vaccination are recorded in various Manitoba databases. All H1N1 vaccinated and unvaccinated individuals are eligible to be included in the study population. There will be no exclusion criteria. The list of specific adverse events of special interest (AESIs) includes: anaphylaxis, Bell's palsy, convulsions, demyelination, encephalitis, Guillain-Barré syndrome, neuritis, vasculitis and various pregnancy outcomes.

Vaccinated individuals will be identified using the Manitoba Immunization Monitoring System (MIMS). Unvaccinated individuals will be identified using the Population Registry. AESIs and other clinically relevant information will be determined using hospital, physician claim and DPIN databases.

The primary statistical analysis will be a comparison of the overall and age specific rates of deaths and AESIs in the vaccinated cohort relative to the non-vaccinated cohort. The two cohorts will be matched on age (month and year of birth), sex and postal code of residence. The analyses will be stratified by specific subgroups: (e.g. pregnant women, persons who are immune suppressed or with autoimmune disorders).

The observed number of events will be determined from the date of first vaccination for each subject and the matched control until the first occurrence of a specific event. Information on events for each person will be derived from the medical claims and hospitalization databases. The person years at risk will be calculated from the date of first vaccination until the first occurrence of the specific event, emigration from Manitoba, or until 6 months after vaccination. Incidence rate ratios and 95% confidence intervals will be calculated by comparing the standardized incidence rates in the vaccinated cohort with those in the matched non vaccinated cohort.

In addition, the observed number of deaths and AESIs in the total vaccinated population and in specific subgroups (as above) will be compared to the expected numbers based on the age sex specific rates in the general Manitoba population. Similar to the matched cohort component, the observed number of events will be determined for the vaccinated individuals from the date of first vaccination until the first occurrence of a specific event, and the person years at risk will be calculated from the date of first vaccination until the first occurrence of the specific event, emigration from Manitoba, or until 6 months after vaccination. The background rate of targeted events will be calculated utilizing information from the mortality, physician claims and hospitalization databases for the total population in Manitoba for the period 2004 2008. Since the risk of some of the events is low, calculating the age sex specific rates based on five years of data will increase the stability of the rates. The expected number of events will be calculated by multiplying the person years at risk by the age sex specific background rate of each targeted event. Standardized incidence ratios (SIRs) or mortality ratios (SMRs) will be calculated as the number of observed events over the number of expected events, with 95% confidence intervals. To assess the absolute burden of an eventual excess in observed number of events the absolute difference between the observed and expected number of events for certain AESIs will also be calculated.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Residents of the Province of Manitoba, population approximately 1.2 million

Criteria

Inclusion Criteria:

  • All 6-month or older Manitoba residents are eligible

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421251

Locations
Canada, Manitoba
International Centre for Infectious Diseases
Winnipeg, Manitoba, Canada, R3B 3P5
Sponsors and Collaborators
International Centre for Infectious Diseases, Canada
GlaxoSmithKline
Investigators
Principal Investigator: Salah Mahmud, M.D., Ph.D. University of Manitoba
  More Information

No publications provided

Responsible Party: International Centre for Infectious Diseases, Canada
ClinicalTrials.gov Identifier: NCT01421251     History of Changes
Other Study ID Numbers: ICID-2011-H1N1-01
Study First Received: August 19, 2011
Last Updated: September 11, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by International Centre for Infectious Diseases, Canada:
H1N1
Flu
Influenza
Vaccine
Manitoba
Canada
Safety

ClinicalTrials.gov processed this record on September 29, 2014