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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
Sponsor: GlaxoSmithKline
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.
Official title: 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
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10212
Start Date
2024-08-01
Completion Date
2026-09-30
Last Updated
2026-03-09
Healthy Volunteers
Yes
Conditions
Interventions
RSVPreF3 OA vaccine
RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)
Locations (250)
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Cerritos, California, United States
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Doral, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Lake City, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pinellas Park, Florida, United States
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The Villages, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Mishawaka, Indiana, United States
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El Dorado, Kansas, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Rockville, Maryland, United States
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Richfield, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Rochester, New York, United States
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Hickory, North Carolina, United States
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Mooresville, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Centerville, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Erie, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Anderson, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Keller, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Botany, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Sydney, New South Wales, Australia
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Taringa, Queensland, Australia
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Tarragindi, Queensland, Australia
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Camberwell, Victoria, Australia
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Geelong, Victoria, Australia
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Spearwood, Western Australia, Australia
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Diepenbeek, Belgium
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Edegem, Belgium
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Erpent, Belgium
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Genk, Belgium
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Ghent, Belgium
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Ieper, Belgium
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Kluisbergen, Belgium
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Linkebeek, Belgium
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Linkebeek, Belgium
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Mechelen, Belgium
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Tremelo, Belgium
GSK Investigational Site
Edmonton, Alberta, Canada
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New Westminster, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
GSK Investigational Site
Truro, Nova Scotia, Canada
GSK Investigational Site
Greater Sudbury, Ontario, Canada
GSK Investigational Site
London-Ontario, Ontario, Canada
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Sarnia, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
GSK Investigational Site
Mirabel, Quebec, Canada
GSK Investigational Site
Pointe-Claire, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, Canada
GSK Investigational Site
Sainte-Foy, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
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Paide, Estonia
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Tallinn, Estonia
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Tallinn, Estonia
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Tallinn, Estonia
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Tallinn, Estonia
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Tartu, Estonia
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Kokkola, Finland
GSK Investigational Site
Oulu, Finland
GSK Investigational Site
Seinäjoki, Finland
GSK Investigational Site
Tampere, Finland
GSK Investigational Site
Turku, Finland
GSK Investigational Site
Weinheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Freiberg, Saxony, Germany
GSK Investigational Site
Berlin, Germany
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Berlin, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Cologne, Germany
GSK Investigational Site
Dachau, Germany
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Dippoldiswalde, Germany
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Dresden, Germany
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Essen, Germany
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Essen, Germany
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Frankfurt, Germany
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Freital, Germany
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Goch, Germany
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Hamburg, Germany
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Hamburg, Germany
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Hanover, Germany
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Hochheim am Main, Germany
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Leipzig, Germany
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Mainz, Germany
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Schenefeld, Germany
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Wallerfing, Germany
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Wangen, Germany
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Witten, Germany
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Würzburg, Germany
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Alessandria, Italy
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Bari, Italy
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Belluno, Italy
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Ferrara, Italy
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Naples, Italy
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Negrar Verona, Italy
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Palermo, Italy
GSK Investigational Site
Pessione - Chieri to, Italy
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Pisa, Italy
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Roma, Italy
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Siena, Italy
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Hiroshima, Japan
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Ibaraki, Japan
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Kumamoto, Japan
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Okinawa, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tokyo, Japan
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Tokyo, Japan
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Tokyo, Japan
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Tokyo, Japan
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Yamagata, Japan
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Yamaguchi, Japan
GSK Investigational Site
Chihuahua City, Mexico
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León, Mexico
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Mexico City, Mexico
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Mérida, Mexico
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Monterrey, Mexico
GSK Investigational Site
Oaxaca City, Mexico
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Querétaro, Mexico
GSK Investigational Site
RM Pharmamexico CITY, Mexico
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San Luis Potosí City, Mexico
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Grafton Auckland, New Zealand
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Hawke's Bay, New Zealand
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Kapiti, New Zealand
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Palmerston North, New Zealand
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Tauranga, New Zealand
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Wellington, New Zealand
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Częstochowa, Poland
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Elblag, Poland
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Gdansk, Poland
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Gdynia, Poland
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Katowice, Poland
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Katowice, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lodz, Poland
GSK Investigational Site
Poznan, Poland
GSK Investigational Site
Warsaw, Poland
GSK Investigational Site
Warsaw, Poland
GSK Investigational Site
Wroclaw, Poland
GSK Investigational Site
Wroclaw, Poland
GSK Investigational Site
Gatchina, Leningradskaya Oblast', Russia
GSK Investigational Site
Barnaul, Russia
GSK Investigational Site
Kemerovo, Russia
GSK Investigational Site
Moscow, Russia
GSK Investigational Site
Saint Petersburg, Russia
GSK Investigational Site
Saint Petersburg, Russia
GSK Investigational Site
StPetersburg, Russia
GSK Investigational Site
StPetersburg, Russia
GSK Investigational Site
Yekaterinburg, Russia
GSK Investigational Site
Bloemfontein, South Africa
GSK Investigational Site
Cape Town, South Africa
GSK Investigational Site
Johannesburg, South Africa
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Johannesburg, South Africa
GSK Investigational Site
Middelburg, South Africa
GSK Investigational Site
Moloto South, South Africa
GSK Investigational Site
Reiger Park, South Africa
GSK Investigational Site
Tembisa, South Africa
GSK Investigational Site
Ansan, South Korea
GSK Investigational Site
Bucheon-si Kyunggi-do 14584, South Korea
GSK Investigational Site
Daegu, South Korea
GSK Investigational Site
Incheon, South Korea
GSK Investigational Site
Jeonju, South Korea
GSK Investigational Site
Kangwon-do, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Suwon Gyeonggi-do, South Korea
GSK Investigational Site
Alcorcón, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
GSK Investigational Site
Madrid, Spain
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Madrid, Spain
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Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Santiago de Compostela, Spain
GSK Investigational Site
Valencia, Spain
GSK Investigational Site
Bebington, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Bradford on Avon Wiltsh, United Kingdom
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Cardiff, United Kingdom
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Corby, United Kingdom
GSK Investigational Site
Eynsham, United Kingdom
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Glasgow, United Kingdom
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Hexham, United Kingdom
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Lancashire, United Kingdom
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Liverpool, United Kingdom
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Manchester, United Kingdom
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Orpington, United Kingdom
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Oxford, United Kingdom
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Peterborough, United Kingdom
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Royal Leamington Spa, United Kingdom
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Thetford, United Kingdom
GSK Investigational Site
Witney, United Kingdom