NCT01421251

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

August 19, 2011

Last Update Submit

September 11, 2012

Conditions

H1N1 Influenza

Keywords

H1N1FluInfluenzaVaccineManitobaCanadaSafety

Outcome Measures

Primary Outcomes (1)

  • Adverse Effects of H1N1 vaccination

    Incidence rate ratios of certain vaccination adverse effects

    One year

Secondary Outcomes (2)

  • Incidence Ratios of Adverse Effects

    One year

  • Sex-specific adverse effects of vaccination

    One year

Study Arms (1)

Matched cohorts - population based

Two cohorts: vaccinated individuals are matched to unvaccinated individuals on the basis of age, sex, and postal code of residence.

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of the Province of Manitoba, population approximately 1.2 million

You may qualify if:

  • All 6-month or older Manitoba residents are eligible

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Infectious Diseases

Winnipeg, Manitoba, R3B 3P5, Canada

Location

Biospecimen

Retention: NONE RETAINED

None collected

MeSH Terms

Conditions

Orthomyxoviridae InfectionsInfluenza, Human

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Salah Mahmud, M.D., Ph.D.

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

CA(1)