Phase
Condition
N/ATreatment
RSVPreF3 OA vaccine
Clinical Study ID
Ages > 60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants who were previously enrolled in the RSV OA=ADJ-006 studyand 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 therequirements of the protocol (e.g. completion of the diary cards, attend regularphone calls/study site visits, ability to access and utilize a phone or otherelectronic communications).
Written or witnessed informed consent obtained from the participant prior toperformance of any study specific procedure.
Participants who are medically stable in the opinion of the investigator at studyentry. Participants with chronic stable medical conditions with or without specifictreatment, such as diabetes, hypertension or cardiac disease, are allowed toparticipate in this study.
Exclusion
Exclusion Criteria:
Medical Conditions:
Any confirmed or suspected immunosuppressive or immunodeficient condition resultingfrom disease or immunosuppressive/cytotoxic therapy based on medical history andphysical examination.
History of any reaction or hypersensitivity likely to be exacerbated by anycomponent 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 beexpected to prevent completion of the study.
Any other medical condition that in the judgment of the investigator would makeintramuscular injection unsafe.
Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the study.
Any history of dementia or any medical condition that moderately or severely impairscognition and understanding of the informed consent form and/or study procedures.
Participants who experienced an SAE or pIMD from first study interventionadministration in the RSV OA=ADJ-006 study until enrollment in this study that wasconsidered to be possibly or probably related to the study vaccine or non-studyconcomitant vaccines, either by the investigator or the sponsor, includinghypersensitivity reactions.
Participants with a new onset of a pIMD or exacerbation of a pIMD from first studyintervention administration in the RSV OA=ADJ-006 study until enrollment in thisstudy, that, in the opinion of the investigator, exposes the participant tounacceptable 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 theinvestigator to render the potential participant unable/unlikely to provide accuratesafety reports or comply with study procedures.
Participation of any study personnel or their immediate dependents, family, orhousehold 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 theperiod starting 30 days before and ending 30 days after study interventionadministration, with the exception of COVID vaccines and inactivated seasonalinfluenza vaccines which can be administered up to 14 days before or from 14 daysafter study intervention administration.
Administration of long-acting immune-modifying drugs or planned administration atany time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 90 days before the first study visit or plannedadministration during the study period.
Chronic administration of immunosuppressants or other immunemodifying drugs duringthe period starting 90 days prior to the first study visit or planned administrationduring the study period. For corticosteroids, this will mean prednisone >= 20mg/day, or equivalent. Inhaled and topical steroids are allowed.
Study Design
Connect with a study center
GSK Investigational Site
Botany, New South Wales 2019
AustraliaActive - Recruiting
GSK Investigational Site
Coffs Harbour, New South Wales 2450
AustraliaActive - Recruiting
GSK Investigational Site
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
GSK Investigational Site
Taringa, Queensland 4068
AustraliaActive - Recruiting
GSK Investigational Site
Tarragindi, Queensland 4121
AustraliaActive - Recruiting
GSK Investigational Site
Camberwell, Victoria 3124
AustraliaActive - Recruiting
GSK Investigational Site
Geelong, Victoria 3220
AustraliaActive - Recruiting
GSK Investigational Site
Murdoch, Western Australia 6163
AustraliaActive - Recruiting
GSK Investigational Site
Alken, 3570
BelgiumSite Not Available
GSK Investigational Site
Diepenbeek, 3590
BelgiumActive - Recruiting
GSK Investigational Site
Edegem, 2650
BelgiumActive - Recruiting
GSK Investigational Site
Erpent, 5101
BelgiumActive - Recruiting
GSK Investigational Site
Genk, 3600
BelgiumActive - Recruiting
GSK Investigational Site
Gent, 9000
BelgiumActive - Recruiting
GSK Investigational Site
Ieper, 8900
BelgiumActive - Recruiting
GSK Investigational Site
Kluisbergen, 9690
BelgiumActive - Recruiting
GSK Investigational Site
Linkebeek, 3545
BelgiumActive - Recruiting
GSK Investigational Site
Mechelen, 2800
BelgiumActive - Recruiting
GSK Investigational Site
Tremelo, 3120
BelgiumActive - Recruiting
GSK Investigational Site
Edmonton, Alberta T5A 4L8
CanadaActive - Recruiting
GSK Investigational Site
New Westminster, British Columbia V3L 3W4
CanadaActive - Recruiting
GSK Investigational Site
Surrey, British Columbia V3S 2N6
CanadaActive - Recruiting
GSK Investigational Site
Vancouver, British Columbia V6Z 2T1
CanadaActive - Recruiting
GSK Investigational Site
Victoria, British Columbia V8V 4A1
CanadaActive - Recruiting
GSK Investigational Site
Halifax, Nova Scotia B3J 3G9
CanadaActive - Recruiting
GSK Investigational Site
Truro, Nova Scotia B2N 1L2
CanadaActive - Recruiting
GSK Investigational Site
London, Ontario N5W 6A2
CanadaSite Not Available
GSK Investigational Site
London-Ontario, Ontario N5W 6A2
CanadaActive - Recruiting
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
GSK Investigational Site
Sarnia, Ontario N7T 4X3
CanadaActive - Recruiting
GSK Investigational Site
Sudbury, Ontario P3C 1X3
CanadaActive - Recruiting
GSK Investigational Site
Toronto, Ontario M9W 4L6
CanadaActive - Recruiting
GSK Investigational Site
Chicoutimi, Quebec G7H 7Y8
CanadaActive - Recruiting
GSK Investigational Site
Mirabel, Quebec J7J 2K8
CanadaActive - Recruiting
GSK Investigational Site
Pointe-Claire, Quebec H9R4S3
CanadaActive - Recruiting
GSK Investigational Site
Sainte-Foy, Quebec G1E 7G9
CanadaActive - Recruiting
GSK Investigational Site
Sherbrooke, Quebec J1J 2G2
CanadaActive - Recruiting
GSK Investigational Site
St-Charles-Borromee, Quebec J6E 2B4
CanadaActive - Recruiting
GSK Investigational Site
Quebec, G1W 4R4
CanadaActive - Recruiting
GSK Investigational Site
Paide, 72713
EstoniaActive - Recruiting
GSK Investigational Site
Tallinn, 10117
EstoniaActive - Recruiting
GSK Investigational Site
Tartu, 51014
EstoniaActive - Recruiting
GSK Investigational Site
Espoo, 02230
FinlandActive - Recruiting
GSK Investigational Site
Helsinki, 00100
FinlandActive - Recruiting
GSK Investigational Site
Jarvenpaa, 04400
FinlandActive - Recruiting
GSK Investigational Site
Kokkola, 67100
FinlandActive - Recruiting
GSK Investigational Site
Oulu, 90220
FinlandActive - Recruiting
GSK Investigational Site
Seinajoki, 60100
FinlandActive - Recruiting
GSK Investigational Site
Tampere, 33100
FinlandActive - Recruiting
GSK Investigational Site
Turku, 20520
FinlandActive - Recruiting
GSK Investigational Site
Weinheim, Baden-Wuerttemberg 69469
GermanyActive - Recruiting
GSK Investigational Site
Muenchen, Bayern 80339
GermanyActive - Recruiting
GSK Investigational Site
Freiberg, Sachsen 09599
GermanyActive - Recruiting
GSK Investigational Site
Berlin, 13347
GermanyActive - Recruiting
GSK Investigational Site
Dachau, 85221
GermanyActive - Recruiting
GSK Investigational Site
Dippoldiswalde, 01744
GermanyActive - Recruiting
GSK Investigational Site
Dresden, 01279
GermanyActive - Recruiting
GSK Investigational Site
Essen, 45359
GermanyActive - Recruiting
GSK Investigational Site
Floersheim, 65439
GermanyActive - Recruiting
GSK Investigational Site
Frankfurt, 60313
GermanyActive - Recruiting
GSK Investigational Site
Freital, 01705
GermanyActive - Recruiting
GSK Investigational Site
Goch, 47574
GermanyActive - Recruiting
GSK Investigational Site
Hamburg, 20095
GermanyActive - Recruiting
GSK Investigational Site
Hannover, 30159
GermanyActive - Recruiting
GSK Investigational Site
Koeln, 51069
GermanyActive - Recruiting
GSK Investigational Site
Leipzig, 04103
GermanyActive - Recruiting
GSK Investigational Site
Mainz, 55116
GermanyActive - Recruiting
GSK Investigational Site
Schenefeld, 22869
GermanyActive - Recruiting
GSK Investigational Site
Wallerfing, 94574
GermanyActive - Recruiting
GSK Investigational Site
Wangen, 88239
GermanyActive - Recruiting
GSK Investigational Site
Witten, 58455
GermanyActive - Recruiting
GSK Investigational Site
Wuerzburg, 97070
GermanyActive - Recruiting
GSK Investigational Site
Alessandria, 15121
ItalyActive - Recruiting
GSK Investigational Site
Bari, 70124
ItalyActive - Recruiting
GSK Investigational Site
Belluno, 32100
ItalyActive - Recruiting
GSK Investigational Site
Catanzaro, 88100
ItalySite Not Available
GSK Investigational Site
Ferrara, 44124
ItalyActive - Recruiting
GSK Investigational Site
Napoli, 80131
ItalyActive - Recruiting
GSK Investigational Site
Negrar Verona, 37024
ItalyActive - Recruiting
GSK Investigational Site
Palermo, 90127
ItalyActive - Recruiting
GSK Investigational Site
Pessione - Chieri TO, 10023
ItalyActive - Recruiting
GSK Investigational Site
Pisa, 56126
ItalyActive - Recruiting
GSK Investigational Site
Roma, 00128
ItalyActive - Recruiting
GSK Investigational Site
Siena, 53100
ItalyActive - Recruiting
GSK Investigational Site
Hiroshima, 732-0053
JapanActive - Recruiting
GSK Investigational Site
Ibaraki, 306-0041
JapanActive - Recruiting
GSK Investigational Site
Kumamoto, 860-0863
JapanActive - Recruiting
GSK Investigational Site
Okinawa, 901-2393
JapanActive - Recruiting
GSK Investigational Site
Saitama, 350-1122
JapanActive - Recruiting
GSK Investigational Site
Shizuoka, 421-0193
JapanActive - Recruiting
GSK Investigational Site
Tokyo, 160-0017
JapanActive - Recruiting
GSK Investigational Site
Yamagata, 990-0834
JapanActive - Recruiting
GSK Investigational Site
Yamaguchi, 750-0061
JapanActive - Recruiting
GSK Investigational Site
Ansan, 15355
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Bucheon-si Kyunggi-do 14584, 14584
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Daegu, 41944
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Incheon, 400-711
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Jeonju, 54907
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Kangwon-do, 26426
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul, 06351
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Suwon Gyeonggi-do, 442-723
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Chihuahua, 31203
MexicoActive - Recruiting
GSK Investigational Site
Leon, 37530
MexicoActive - Recruiting
GSK Investigational Site
Merida, 97070
MexicoSite Not Available
GSK Investigational Site
Mexico City, 06760
MexicoSite Not Available
GSK Investigational Site
Monterrey, 64460
MexicoActive - Recruiting
GSK Investigational Site
Oaxaca, 68000
MexicoActive - Recruiting
GSK Investigational Site
Queretaro, 76070
MexicoSite Not Available
GSK Investigational Site
RM Pharmamexico CITY, 03100
MexicoActive - Recruiting
GSK Investigational Site
San Luis PotosI, 78209
MexicoActive - Recruiting
GSK Investigational Site
Grafton Auckland, 1010
New ZealandActive - Recruiting
GSK Investigational Site
Hawke's Bay, 4122
New ZealandActive - Recruiting
GSK Investigational Site
Kapiti, 5032
New ZealandActive - Recruiting
GSK Investigational Site
Palmerston North, 4414
New ZealandActive - Recruiting
GSK Investigational Site
Tauranga, 3110
New ZealandActive - Recruiting
GSK Investigational Site
Wellington, 6021
New ZealandActive - Recruiting
GSK Investigational Site
Czestochowa, 42-202
PolandActive - Recruiting
GSK Investigational Site
Elblag, 82-300
PolandActive - Recruiting
GSK Investigational Site
Gdansk, 80-382
PolandActive - Recruiting
GSK Investigational Site
Gdynia, 81-537
PolandActive - Recruiting
GSK Investigational Site
Katowice, 40-648
PolandActive - Recruiting
GSK Investigational Site
Krakow, 31-501
PolandActive - Recruiting
GSK Investigational Site
Lodz, 90-127
PolandActive - Recruiting
GSK Investigational Site
Poznan, 60-702
PolandActive - Recruiting
GSK Investigational Site
Warsaw, 03-291
PolandActive - Recruiting
GSK Investigational Site
Warszawa, 02-672
PolandActive - Recruiting
GSK Investigational Site
Wroclaw, 53-671
PolandActive - Recruiting
GSK Investigational Site
Barnaul, 656043
Russian FederationActive - Recruiting
GSK Investigational Site
Ekaterinburg, 620137
Russian FederationActive - Recruiting
GSK Investigational Site
Gatchina, 188300
Russian FederationActive - Recruiting
GSK Investigational Site
Kemerovo, 650066
Russian FederationActive - Recruiting
GSK Investigational Site
Moscow, 115478
Russian FederationActive - Recruiting
GSK Investigational Site
Saint-Petersburg, 196158
Russian FederationActive - Recruiting
GSK Investigational Site
StPetersburg, 191119
Russian FederationActive - Recruiting
GSK Investigational Site
Bloemfontein, 9300
South AfricaActive - Recruiting
GSK Investigational Site
Cape Town, 7700
South AfricaActive - Recruiting
GSK Investigational Site
Johannesburg, 2113
South AfricaActive - Recruiting
GSK Investigational Site
Middelburg, 1050
South AfricaActive - Recruiting
GSK Investigational Site
Moloto South, 1022
South AfricaCompleted
GSK Investigational Site
Reiger Park, 1459
South AfricaActive - Recruiting
GSK Investigational Site
Tembisa, 1632
South AfricaCompleted
GSK Investigational Site
AlcorcOn, 28922
SpainActive - Recruiting
GSK Investigational Site
Barcelona, 08540
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28222
SpainCompleted
GSK Investigational Site
Santiago de Compostela, 15706
SpainActive - Recruiting
GSK Investigational Site
Valencia, 46020
SpainActive - Recruiting
GSK Investigational Site
Bradford on Avon, Wiltshire BA15 1DQ
United KingdomSite Not Available
GSK Investigational Site
Bebington, CH63 9JP
United KingdomActive - Recruiting
GSK Investigational Site
Belfast, BT2 8BG
United KingdomActive - Recruiting
GSK Investigational Site
Birmingham, B15 2SQ
United KingdomActive - Recruiting
GSK Investigational Site
Bradford On Avon Wiltsh, BA15 1DQ
United KingdomActive - Recruiting
GSK Investigational Site
Cardiff, CF15 9SS
United KingdomActive - Recruiting
GSK Investigational Site
Corby, NN17 2UR
United KingdomActive - Recruiting
GSK Investigational Site
Eynsham, OX29 4QB
United KingdomActive - Recruiting
GSK Investigational Site
Glasgow, ML4 3NJ
United KingdomActive - Recruiting
GSK Investigational Site
Hexham, NE46 1QJ
United KingdomActive - Recruiting
GSK Investigational Site
Lancashire, PR7 7NA
United KingdomActive - Recruiting
GSK Investigational Site
Leamington Spa, CV32 4RA
United KingdomActive - Recruiting
GSK Investigational Site
Liverpool, L22 0LG
United KingdomActive - Recruiting
GSK Investigational Site
Manchester, M15 6SE
United KingdomActive - Recruiting
GSK Investigational Site
Orpington, BR5 3QG
United KingdomActive - Recruiting
GSK Investigational Site
Oxford, OX4 1XB
United KingdomActive - Recruiting
GSK Investigational Site
Peterborough, PE8 6PL
United KingdomActive - Recruiting
GSK Investigational Site
Thetford, IP24 1JD
United KingdomActive - Recruiting
GSK Investigational Site
Witney, OX28 6JS
United KingdomActive - Recruiting
GSK Investigational Site
Birmingham, Alabama 35211
United StatesActive - Recruiting
GSK Investigational Site
Huntsville, Alabama 35802
United StatesActive - Recruiting
GSK Investigational Site
Phoenix, Arizona 85306
United StatesActive - Recruiting
GSK Investigational Site
Tucson, Arizona 85741
United StatesActive - Recruiting
GSK Investigational Site
Cerritos, California 90703
United StatesActive - Recruiting
GSK Investigational Site
Coral Gables, Florida 33134
United StatesActive - Recruiting
GSK Investigational Site
Fort Myers, Florida 33912
United StatesActive - Recruiting
GSK Investigational Site
Jacksonville, Florida 32205
United StatesActive - Recruiting
GSK Investigational Site
Lake City, Florida 32055
United StatesActive - Recruiting
GSK Investigational Site
Melbourne, Florida 32934
United StatesActive - Recruiting
GSK Investigational Site
Miami, Florida 33174
United StatesActive - Recruiting
GSK Investigational Site
Orlando, Florida 32806
United StatesActive - Recruiting
GSK Investigational Site
Pinellas Park, Florida 33781
United StatesCompleted
GSK Investigational Site
The Villages, Florida 32162
United StatesActive - Recruiting
GSK Investigational Site
West Palm Beach, Florida 33409
United StatesActive - Recruiting
GSK Investigational Site
Atlanta, Georgia 30328
United StatesActive - Recruiting
GSK Investigational Site
Savannah, Georgia 31406
United StatesActive - Recruiting
GSK Investigational Site
Chicago, Illinois 60602
United StatesActive - Recruiting
GSK Investigational Site
Evansville, Indiana 47714
United StatesActive - Recruiting
GSK Investigational Site
Mishawaka, Indiana 46544
United StatesActive - Recruiting
GSK Investigational Site
El Dorado, Kansas 67042
United StatesActive - Recruiting
GSK Investigational Site
Newton, Kansas 67114
United StatesActive - Recruiting
GSK Investigational Site
Wichita, Kansas 67207
United StatesActive - Recruiting
GSK Investigational Site
Lexington, Kentucky 40509
United StatesActive - Recruiting
GSK Investigational Site
Rockville, Maryland 20854
United StatesActive - Recruiting
GSK Investigational Site
Richfield, Minnesota 55423
United StatesActive - Recruiting
GSK Investigational Site
Kansas City, Missouri 64114
United StatesActive - Recruiting
GSK Investigational Site
Saint Louis, Missouri 63141
United StatesActive - Recruiting
GSK Investigational Site
Omaha, Nebraska 68134
United StatesActive - Recruiting
GSK Investigational Site
Henderson, Nevada 89052
United StatesSite Not Available
GSK Investigational Site
Las Vegas, Nevada 89113
United StatesActive - Recruiting
GSK Investigational Site
New York, New York 10017
United StatesActive - Recruiting
GSK Investigational Site
Rochester, New York 14609
United StatesActive - Recruiting
GSK Investigational Site
Hickory, North Carolina 28601
United StatesActive - Recruiting
GSK Investigational Site
Mooresville, North Carolina 28117
United StatesActive - Recruiting
GSK Investigational Site
Rocky Mount, North Carolina 27804
United StatesActive - Recruiting
GSK Investigational Site
Salisbury, North Carolina 28144
United StatesActive - Recruiting
GSK Investigational Site
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
GSK Investigational Site
Akron, Ohio 44311
United StatesSite Not Available
GSK Investigational Site
Centerville, Ohio 45459
United StatesActive - Recruiting
GSK Investigational Site
Cincinnati, Ohio 45236
United StatesActive - Recruiting
GSK Investigational Site
Columbus, Ohio 43212
United StatesCompleted
GSK Investigational Site
Erie, Pennsylvania 16508
United StatesActive - Recruiting
GSK Investigational Site
Pittsburgh, Pennsylvania 15236
United StatesActive - Recruiting
GSK Investigational Site
Anderson, South Carolina 29621
United StatesActive - Recruiting
GSK Investigational Site
Mount Pleasant, South Carolina 29405
United StatesActive - Recruiting
GSK Investigational Site
Knoxville, Tennessee 37938
United StatesActive - Recruiting
GSK Investigational Site
Memphis, Tennessee 38119
United StatesActive - Recruiting
GSK Investigational Site
Dallas, Texas 75234
United StatesActive - Recruiting
GSK Investigational Site
Fort Worth, Texas 76104
United StatesActive - Recruiting
GSK Investigational Site
Houston, Texas 77008
United StatesActive - Recruiting
GSK Investigational Site
Keller, Texas 76248
United StatesActive - Recruiting
GSK Investigational Site
San Antonio, Texas 78229
United StatesActive - Recruiting
GSK Investigational Site
Salt Lake City, Utah 84106
United StatesActive - Recruiting
GSK Investigational Site
Norfolk, Virginia 23502
United StatesActive - Recruiting
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