Influenza Clinical Trial
Official title:
Effectiveness of the GSK Pandemic H1N1 Influenza Vaccines in Preventing Hospitalization for Influenza and Pneumonia in Manitoba, Canada
Excellent immune responses following 1 or 2 doses of the GSK monovalent AS03-adjuvanted
pandemic H1N1 (pH1N1) vaccines (e.g., Arepanrix®) have been documented in several trials.
Observational studies have found that these vaccines were effective in preventing laboratory
confirmed influenza infections. However, it remains unclear whether vaccination during the
pandemic was associated with reductions in more clinically meaningful outcomes, such as
hospitalizations, severe illness, complications, and death.
The investigators propose to evaluate the effectiveness of the GSK adjuvanted and
non-adjuvanted pH1N1 vaccines used in Manitoba in preventing hospitalization and severe
illness (defined as illness necessitating admission to intensive care or associated with
major complications) due to influenza or pneumonia by means of a case-control study using
data from Manitoba Health (MH) administrative databases and the database of the Cadham
Provincial Laboratory. The primary outcome will be hospitalization with laboratory-confirmed
influenza or pneumonia. A secondary outcome will be hospitalization with influenza or
pneumonia. The investigators will also assess the effectiveness of the above vaccines for
different age groups and among high-risk populations, e.g., immunocompromised individuals.
Status | Unknown status |
Enrollment | 1860 |
Est. completion date | December 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months and older |
Eligibility |
Inclusion Criteria: - Any adult or child > 6 months of age who normally resides in Manitoba and who has been continuously covered during the study period and with a diagnosis of influenza (ICD-10: J09-J11) or pneumonia (ICD-10: J12-J18) will be eligible for inclusion as cases in the study. |
Country | Name | City | State |
---|---|---|---|
Canada | International Centre for Infectious Diseases | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
International Centre for Infectious Diseases, Canada | GlaxoSmithKline |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalization with laboratory-confirmed influenza or pneumonia | Data records of hospitalization with laboratory-confirmed influenza or pneumonia | Three months | |
Secondary | Hospitalization with influenza or pneumonia | Data records of hospitalization with influenza or pneumonia | 14 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |