A Phase 3b, Randomized, Open Label, Multicountry, Multi-center, Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OA=ADJ-006 Study
Status: Recruiting
Location: See all (251) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:
• 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.
Locations
United States
Alabama
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Birmingham
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Birmingham
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Huntsville
Arizona
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Phoenix
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Tucson
California
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Cerritos
Florida
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Doral
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Fort Myers
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Jacksonville
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Lake City
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Melbourne
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Miami
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COMPLETED
Orlando
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COMPLETED
Pinellas Park
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The Villages
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West Palm Beach
Georgia
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Atlanta
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Savannah
Illinois
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Chicago
Indiana
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Evansville
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Mishawaka
Kansas
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El Dorado
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Newton
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COMPLETED
Wichita
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Wichita
Kentucky
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Lexington
Maryland
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Rockville
Minnesota
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Richfield
Missouri
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Kansas City
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St Louis
North Carolina
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Hickory
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Mooresville
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Rocky Mount
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Salisbury
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Winston-salem
Nebraska
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Omaha
Nevada
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Las Vegas
New York
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New York
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Rochester
Ohio
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Centerville
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Cincinnati
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Columbus
Pennsylvania
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Erie
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Pittsburgh
South Carolina
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Anderson
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Mt. Pleasant
Tennessee
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Knoxville
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Memphis
Texas
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Dallas
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Fort Worth
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Houston
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Keller
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San Antonio
Utah
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Salt Lake City
Virginia
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Norfolk
Other Locations
Australia
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Botany
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Camberwell
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Coffs Harbour
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Darlinghurst
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Geelong
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Spearwood
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Taringa
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Tarragindi
Belgium
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Diepenbeek
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Edegem
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Erpent
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Genk
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Ghent
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Ieper
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Kluisbergen
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Linkebeek
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Linkebeek
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Mechelen
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Tremelo
Canada
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Chicoutimi
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Edmonton
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Greater Sudbury
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Halifax
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London-ontario
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Mirabel
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New Westminster
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Ottawa
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Pointe-claire
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Québec
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Saint-charles-borromée
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Sainte-foy
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Sarnia
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Sherbrooke
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Surrey
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Toronto
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Truro
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Vancouver
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Victoria
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Victoria
Estonia
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Paide
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Tallinn
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Tallinn
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Tallinn
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Tallinn
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Tartu
Finland
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Espoo
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Helsinki
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COMPLETED
Helsinki
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Järvenpää
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Kokkola
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Oulu
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Seinäjoki
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Tampere
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Turku
Germany
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Berlin
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Berlin
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Berlin
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Cologne
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Dachau
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Dippoldiswalde
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Dresden
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Essen
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Essen
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Frankfurt
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Freiberg
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Freital
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Goch
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Hamburg
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Hamburg
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Hanover
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Hochheim Am Main
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Leipzig
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Mainz
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Munich
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Schenefeld
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Wallerfing
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Wangen
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Weinheim
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Witten
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Würzburg
Italy
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Alessandria
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Bari
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Belluno
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Ferrara
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Napoli
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Negrar Verona
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Palermo
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Pessione - Chieri To
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Pisa
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Roma
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WITHDRAWN
Roma
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Siena
Japan
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Hiroshima
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Ibaraki
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Kumamoto
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Okinawa
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Saitama
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Shizuoka
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Yamagata
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Yamaguchi
Mexico
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Chihuahua City
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León
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Mérida
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Mexico City
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Monterrey
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Oaxaca City
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Querétaro
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Rm Pharmamexico City
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San Luis Potosí City
New Zealand
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COMPLETED
Grafton Auckland
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Hawke's Bay
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Kapiti
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Palmerston North
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Tauranga
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Wellington
Poland
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Częstochowa
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Elblag
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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
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Lodz
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Lodz
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Poznan
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Warsaw
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Warsaw
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Wroclaw
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Wroclaw
Republic of Korea
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Ansan
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Bucheon-si Kyunggi-do 14584
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Daegu
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Incheon
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Jeonju
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Kangwon-do
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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Suwon Gyeonggi-do
Russian Federation
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Barnaul
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Gatchina
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Kemerovo
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COMPLETED
Moscow
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Saint Petersburg
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Saint Petersburg
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Stpetersburg
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Stpetersburg
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Yekaterinburg
South Africa
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COMPLETED
Bloemfontein
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COMPLETED
Cape Town
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COMPLETED
Johannesburg
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COMPLETED
Johannesburg
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COMPLETED
Middelburg
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COMPLETED
Moloto South
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COMPLETED
Reiger Park
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COMPLETED
Tembisa
Spain
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Alcorcón
GSK Investigational Site
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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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Barcelona
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Barcelona
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Madrid
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Madrid
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Madrid
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COMPLETED
Madrid
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Madrid
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Santiago De Compostela
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Valencia
United Kingdom
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Bebington
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Belfast
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Birmingham
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Bradford On Avon Wiltsh
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Cardiff
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Corby
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Eynsham
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Glasgow
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Hexham
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Lancashire
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Liverpool
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Manchester
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Orpington
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Oxford
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Peterborough
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Royal Leamington Spa
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Thetford
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Witney
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date:2024-08-01
Estimated Completion Date:2026-09-30
Participants
Target number of participants:10356
Treatments
Experimental: RSV_PreS4
Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.
Experimental: RSV_PreS5
Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.
No_intervention: RSV_1Dose
Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine.
Experimental: Crossover
Participants in this group will receive a single dose of RSVPreF3 OA vaccine.