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Active (not recruiting) Phase 3 NCT06534892

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Phase 3 – large-scale trial before approval
Conditions: Respiratory Syncytial Virus Infections

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.
Who can participate
Inclusion Criteria: * Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV\_1dose group). * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications). * Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. * Participants who are medically stable in the opinion of the investigator at study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study. Exclusion Criteria: Medical Conditions: * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. * Hypersensitivity to latex. * Serious or unstable chronic illness. * Recurrent or un-controlled neurological disorders or seizures. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. * Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. * Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures. * Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions. * Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination. Prior/Concomitant Therapy: • Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study. Prior/Concurrent Clinical Study Experience: • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product. Other Exclusion Criteria: * History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. * Participation of any study personnel or their immediate dependents, family, or household members. * Bedridden participants. Specific exclusion criteria for Crossover group: • Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines which can be administered up to 14 days before or from 14 days after study vaccination. Inactivated seasonal influenza vaccines can be co-administered or administered at any time. Specific exclusion criteria for RSV\_PreS4, RSV\_PreS5 and RSV\_1Dose groups: * Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines and inactivated seasonal influenza vaccines which can be administered up to 14 days before or from 14 days after study intervention administration. * Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study visit or planned administration during the study period. * Chronic administration of immunosuppressants or other immunemodifying drugs during the period starting 90 days prior to the first study visit or planned administration during the study period. For corticosteroids, this will mean prednisone \>= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Interventions
RSVPreF3 OA vaccine
BIOLOGICAL
Locations 249
Australia (8)
GSK Investigational Site
Botany , New South Wales
GSK Investigational Site
Camberwell , Victoria
GSK Investigational Site
Coffs Harbour , New South Wales
GSK Investigational Site
Geelong , Victoria
GSK Investigational Site
Spearwood , Western Australia
GSK Investigational Site
Sydney , New South Wales
GSK Investigational Site
Taringa , Queensland
GSK Investigational Site
Tarragindi , Queensland
Belgium (11)
GSK Investigational Site
Diepenbeek
GSK Investigational Site
Edegem
GSK Investigational Site
Erpent
GSK Investigational Site
Genk
GSK Investigational Site
Ghent
GSK Investigational Site
Ieper
GSK Investigational Site
Kluisbergen
GSK Investigational Site
Linkebeek
GSK Investigational Site
Linkebeek
GSK Investigational Site
Mechelen
GSK Investigational Site
Tremelo
Canada (20)
GSK Investigational Site
Chicoutimi , Quebec
GSK Investigational Site
Edmonton , Alberta
GSK Investigational Site
Greater Sudbury , Ontario
GSK Investigational Site
Halifax , Nova Scotia
GSK Investigational Site
London-Ontario , Ontario
GSK Investigational Site
Mirabel , Quebec
GSK Investigational Site
New Westminster , British Columbia
GSK Investigational Site
Ottawa , Ontario
GSK Investigational Site
Pointe-Claire , Quebec
GSK Investigational Site
Québec , Quebec
GSK Investigational Site
Saint-Charles-Borromée , Quebec
GSK Investigational Site
Sainte-Foy , Quebec
GSK Investigational Site
Sarnia , Ontario
GSK Investigational Site
Sherbrooke , Quebec
GSK Investigational Site
Surrey , British Columbia
GSK Investigational Site
Toronto , Ontario
GSK Investigational Site
Truro , Nova Scotia
GSK Investigational Site
Vancouver , British Columbia
GSK Investigational Site
Victoria , British Columbia
GSK Investigational Site
Victoria , British Columbia
Estonia (6)
GSK Investigational Site
Paide
GSK Investigational Site
Tallinn
GSK Investigational Site
Tallinn
GSK Investigational Site
Tallinn
GSK Investigational Site
Tallinn
GSK Investigational Site
Tartu
Finland (9)
GSK Investigational Site
Espoo
GSK Investigational Site
Helsinki
GSK Investigational Site
Helsinki
GSK Investigational Site
Jarvenpaa
GSK Investigational Site
Kokkola
GSK Investigational Site
Oulu
GSK Investigational Site
Seinäjoki
GSK Investigational Site
Tampere
GSK Investigational Site
Turku
Germany (25)
GSK Investigational Site
Berlin
GSK Investigational Site
Berlin
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Berlin
GSK Investigational Site
Cologne
GSK Investigational Site
Dachau
GSK Investigational Site
Dippoldiswalde
GSK Investigational Site
Dresden
GSK Investigational Site
Essen
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Essen
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Frankfurt
GSK Investigational Site
Freiberg , Saxony
GSK Investigational Site
Freital
GSK Investigational Site
Goch
GSK Investigational Site
Hamburg
GSK Investigational Site
Hanover
GSK Investigational Site
Hochheim am Main
GSK Investigational Site
Leipzig
GSK Investigational Site
Mainz
GSK Investigational Site
Munich , Bavaria
GSK Investigational Site
Schenefeld
GSK Investigational Site
Wallerfing
GSK Investigational Site
Wangen
GSK Investigational Site
Weinheim , Baden-Wurttemberg
GSK Investigational Site
Witten
GSK Investigational Site
Würzburg
Italy (11)
GSK Investigational Site
Alessandria
GSK Investigational Site
Bari
GSK Investigational Site
Belluno
GSK Investigational Site
Ferrara
GSK Investigational Site
Naples
GSK Investigational Site
Negrar Verona
GSK Investigational Site
Palermo
GSK Investigational Site
Pessione - Chieri to
GSK Investigational Site
Pisa
GSK Investigational Site
Roma
GSK Investigational Site
Siena
Japan (12)
GSK Investigational Site
Hiroshima
GSK Investigational Site
Ibaraki
GSK Investigational Site
Kumamoto
GSK Investigational Site
Okinawa
GSK Investigational Site
Saitama
GSK Investigational Site
Shizuoka
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Yamagata
GSK Investigational Site
Yamaguchi
Mexico (9)
GSK Investigational Site
Chihuahua City
GSK Investigational Site
León
GSK Investigational Site
Mérida
GSK Investigational Site
Mexico City
GSK Investigational Site
Monterrey
GSK Investigational Site
Oaxaca City
GSK Investigational Site
Querétaro
GSK Investigational Site
RM Pharmamexico CITY
GSK Investigational Site
San Luis Potosí City
New Zealand (6)
GSK Investigational Site
Grafton Auckland
GSK Investigational Site
Hawke's Bay
GSK Investigational Site
Kapiti
GSK Investigational Site
Palmerston North
GSK Investigational Site
Tauranga
GSK Investigational Site
Wellington
Poland (15)
GSK Investigational Site
Częstochowa
GSK Investigational Site
Elblag
GSK Investigational Site
Gdansk
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Gdynia
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Katowice
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Katowice
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Katowice
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Krakow
GSK Investigational Site
Lodz
GSK Investigational Site
Lodz
GSK Investigational Site
Poznan
GSK Investigational Site
Warsaw
GSK Investigational Site
Warsaw
GSK Investigational Site
Wroclaw
GSK Investigational Site
Wroclaw
Russia (9)
GSK Investigational Site
Barnaul
GSK Investigational Site
Gatchina , Leningradskaya Oblast'
GSK Investigational Site
Kemerovo
GSK Investigational Site
Moscow
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
Saint Petersburg
GSK Investigational Site
StPetersburg
GSK Investigational Site
StPetersburg
GSK Investigational Site
Yekaterinburg
South Africa (8)
GSK Investigational Site
Bloemfontein
GSK Investigational Site
Cape Town
GSK Investigational Site
Johannesburg
GSK Investigational Site
Johannesburg
GSK Investigational Site
Middelburg
GSK Investigational Site
Moloto South
GSK Investigational Site
Reiger Park , Gauteng
GSK Investigational Site
Tembisa
South Korea (12)
GSK Investigational Site
Ansan
GSK Investigational Site
Bucheon-si Kyunggi-do 14584
GSK Investigational Site
Daegu
GSK Investigational Site
Incheon
GSK Investigational Site
Jeonju
GSK Investigational Site
Kangwon-do
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Suwon Gyeonggi-do
Spain (15)
GSK Investigational Site
Alcorcón
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
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Barcelona
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Barcelona
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Barcelona
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Barcelona
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Madrid
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Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Santiago de Compostela
GSK Investigational Site
Valencia
United Kingdom (18)
GSK Investigational Site
Bebington
GSK Investigational Site
Belfast
GSK Investigational Site
Birmingham
GSK Investigational Site
Bradford on Avon Wiltsh
GSK Investigational Site
Cardiff
GSK Investigational Site
Corby
GSK Investigational Site
Eynsham
GSK Investigational Site
Glasgow
GSK Investigational Site
Hexham
GSK Investigational Site
Lancashire
GSK Investigational Site
Liverpool
GSK Investigational Site
Manchester
GSK Investigational Site
Orpington
GSK Investigational Site
Oxford
GSK Investigational Site
Peterborough
GSK Investigational Site
Royal Leamington Spa
GSK Investigational Site
Thetford
GSK Investigational Site
Witney
United States (55)
GSK Investigational Site
Anderson , South Carolina
GSK Investigational Site
Atlanta , Georgia
GSK Investigational Site
Birmingham , Alabama
GSK Investigational Site
Birmingham , Alabama
GSK Investigational Site
Centerville , Ohio
GSK Investigational Site
Cerritos , California
GSK Investigational Site
Chicago , Illinois
GSK Investigational Site
Cincinnati , Ohio
GSK Investigational Site
Columbus , Ohio
GSK Investigational Site
Dallas , Texas
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Doral , Florida
GSK Investigational Site
El Dorado , Kansas
GSK Investigational Site
Erie , Pennsylvania
GSK Investigational Site
Evansville , Indiana
GSK Investigational Site
Fort Myers , Florida
GSK Investigational Site
Fort Worth , Texas
GSK Investigational Site
Hickory , North Carolina
GSK Investigational Site
Houston , Texas
GSK Investigational Site
Huntsville , Alabama
GSK Investigational Site
Jacksonville , Florida
GSK Investigational Site
Kansas City , Missouri
GSK Investigational Site
Keller , Texas
GSK Investigational Site
Knoxville , Tennessee
GSK Investigational Site
Lake City , Florida
GSK Investigational Site
Las Vegas , Nevada
GSK Investigational Site
Lexington , Kentucky
GSK Investigational Site
Melbourne , Florida
GSK Investigational Site
Memphis , Tennessee
GSK Investigational Site
Miami , Florida
GSK Investigational Site
Mishawaka , Indiana
GSK Investigational Site
Mooresville , North Carolina
GSK Investigational Site
Mt. Pleasant , South Carolina
GSK Investigational Site
New York , New York
GSK Investigational Site
Newton , Kansas
GSK Investigational Site
Norfolk , Virginia
GSK Investigational Site
Omaha , Nebraska
GSK Investigational Site
Orlando , Florida
GSK Investigational Site
Phoenix , Arizona
GSK Investigational Site
Pinellas Park , Florida
GSK Investigational Site
Pittsburgh , Pennsylvania
GSK Investigational Site
Richfield , Minnesota
GSK Investigational Site
Rochester , New York
GSK Investigational Site
Rockville , Maryland
GSK Investigational Site
Rocky Mount , North Carolina
GSK Investigational Site
Salisbury , North Carolina
GSK Investigational Site
Salt Lake City , Utah
GSK Investigational Site
San Antonio , Texas
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Savannah , Georgia
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St Louis , Missouri
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The Villages , Florida
GSK Investigational Site
Tucson , Arizona
GSK Investigational Site
West Palm Beach , Florida
GSK Investigational Site
Wichita , Kansas
GSK Investigational Site
Wichita , Kansas
GSK Investigational Site
Winston-Salem , North Carolina
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
60 Years
Healthy volunteers
No
Start date
01.08.2024
Completion date
30.09.2026
Registry ID
NCT06534892
Source
clinicaltrials.gov
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