Last updated: 05/08/2023 11:50:14
An epidemiological study to assess the disease burden of respiratory syncytial virus (RSV) associated acute respiratory infection (ARI) in adults ≥ 50 years of age during two consecutive RSV seasons in the United States (US) and Europe
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An epidemiological study to assess the disease burden of respiratory syncytial virus (RSV) associated acute respiratory infection (ARI) in adults ≥ 50 years of age during two consecutive RSV seasons in the United States (US) and Europe
Trial description: As the burden of disease of RSV is not well characterized in the older adult population and in order to support the development of a phase III trial with GSK Biologicals’ candidate vaccine, this study will estimate the disease burden of RSV in older adults living in the community or in long term care facilities, as well as assess the operational feasibility of conducting a phase III clinical trial on a larger scale.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1981
Primary completion date:
2021-30-06
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Sílvia Narejos Pérez, Josep María Ramón Torrell, Airi Põder, Isabel Leroux-Roels, Lina Pérez-Breva, Katie Steenackers, Corinne Vandermeulen, Sandra Meisalu, Damien McNally, Jordan S T Bowen, Amardeep Heer, Adrian Beltran Martinez, Laura L Helman, Amit Arora, Robert G Feldman, Rajul Patel, Amit Shah, Raghavendra Devadiga, Silvia Damaso, Sean Matthews, Jean-Yves Pirçon, Dominique Luyts. Respiratory Syncytial Virus Disease Burden in Community-Dwelling and Long-Term Care Facility Older Adults in Europe and the United States: A Prospective Study.. Open forum infectious diseases. 2023-03-01;10(4): ofad111.
DOI:10.1093/ofid/ofad111
PMID: 37065988
Medical condition
Respiratory Syncytial Virus Infections
Product
GSK2647160A
Collaborators
Not applicable
Study date(s)
May 2019 to July 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
Not applicable
- Male and female subjects ≥50 years of age, at enrolment, who live in the community (CD subjects)
- OR
- History of vaccination with an investigational RSV vaccine and administration of any RSV drugs or planned administration anytime during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Male and female subjects ≥50 years of age, at enrolment, who live in the community (CD subjects) OR
- Male or female subjects ≥65 years of age, at enrolment, who live in LTCF (LTCF subjects).
- Subjects who, in the opinion of the investigator, are able to understand and comply with the study requirements (attend regular phone calls/study site visits/home visits/self-completion of HRQoL questionnaires)
- Subjects who are medically stable in the opinion of the investigator.
- Subjects who are planning, at time of enrolment, to remain at the same LTCF or in the community during the two-year study period.
- Subjects who are able to provide written informed consent.
Exclusion criteria:
- History of vaccination with an investigational RSV vaccine and administration of any RSV drugs or planned administration anytime during the study period.
Trial location(s)
Location
GSK Investigational Site
Centerville, Ohio, United States, 45459
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Saginaw, Michigan, United States, 48603
Status
Study Complete
Location
GSK Investigational Site
Fort Mill, South Carolina, United States, 29707
Status
Study Complete
Location
GSK Investigational Site
Mishawaka, Indiana, United States, 46544
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4AA
Status
Study Complete
Location
GSK Investigational Site
Dippoldiswalde, Sachsen, Germany, 01744
Status
Study Complete
Location
GSK Investigational Site
Brooksville, Florida, United States, 34613
Status
Study Complete
Location
GSK Investigational Site
Corby, Northamptonshire, United Kingdom, NN17 2UR
Status
Study Complete
Location
GSK Investigational Site
Laguna Hills, California, United States, 92653
Status
Study Complete
Location
GSK Investigational Site
Leamington Spa, Warwickshire, United Kingdom, CV32 4RA
Status
Study Complete
Location
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78212
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Stoke-on-Trent, Staffordshire, United Kingdom, ST6 7AG
Status
Study Complete
Location
GSK Investigational Site
Thetford, Norfolk, United Kingdom, IP24 2HY
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2021-30-06
Actual study completion date
2021-29-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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