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, 2019
AustraliaSite Not Available
GSK Investigational Site
Camberwell, 3124
AustraliaSite Not Available
GSK Investigational Site
Coffs Harbour, 2450
AustraliaSite Not Available
GSK Investigational Site
Darlinghurst, 2010
AustraliaSite Not Available
GSK Investigational Site
Geelong, 3220
AustraliaSite Not Available
GSK Investigational Site
Murdoch, 6163
AustraliaSite Not Available
GSK Investigational Site
Taringa, 4068
AustraliaSite Not Available
GSK Investigational Site
Tarragindi, 4121
AustraliaSite Not Available
GSK Investigational Site
Alken, 3570
BelgiumSite Not Available
GSK Investigational Site
Edegem, 2610
BelgiumSite Not Available
GSK Investigational Site
Erpent, 5101
BelgiumSite Not Available
GSK Investigational Site
Genk, 3600
BelgiumSite Not Available
GSK Investigational Site
Gent, 9000
BelgiumSite Not Available
GSK Investigational Site
Ieper, 8900
BelgiumSite Not Available
GSK Investigational Site
Linkebeek, 3544
BelgiumSite Not Available
GSK Investigational Site
Mechelen, 2800
BelgiumSite Not Available
GSK Investigational Site
Tremelo, 3120
BelgiumSite Not Available
GSK Investigational Site
London, Ontario N5W 6A2
CanadaSite Not Available
GSK Investigational Site
Chicoutimi, G7H 7Y8
CanadaSite Not Available
GSK Investigational Site
Edmonton, T5A 4L8
CanadaSite Not Available
GSK Investigational Site
Halifax, B3J 3G9
CanadaSite Not Available
GSK Investigational Site
London-Ontario, N5W 6A2
CanadaSite Not Available
GSK Investigational Site
Mirabel, J7J 2K8
CanadaSite Not Available
GSK Investigational Site
New Westminster, V3L 3W4
CanadaSite Not Available
GSK Investigational Site
Ottawa, K1H 8L6
CanadaSite Not Available
GSK Investigational Site
Pointe-Claire, H9R4S3
CanadaSite Not Available
GSK Investigational Site
Quebec, G1W 4R4
CanadaSite Not Available
GSK Investigational Site
Sainte-Foy, G1E 7G9
CanadaSite Not Available
GSK Investigational Site
Sarnia, N7T 4X3
CanadaSite Not Available
GSK Investigational Site
Sherbrooke, J1J 2G2
CanadaSite Not Available
GSK Investigational Site
St-Charles-Borromee, J6E 2B4
CanadaSite Not Available
GSK Investigational Site
Sudbury, P3C 1X3
CanadaSite Not Available
GSK Investigational Site
Surrey, V3S 2N6
CanadaSite Not Available
GSK Investigational Site
Toronto, M9W 4L6
CanadaSite Not Available
GSK Investigational Site
Truro, B2N 1L2
CanadaSite Not Available
GSK Investigational Site
Vancouver, V6Z 2T1
CanadaSite Not Available
GSK Investigational Site
Victoria, V8V 3M9
CanadaSite Not Available
GSK Investigational Site
Paide, 72713
EstoniaSite Not Available
GSK Investigational Site
Tallinn, 10128
EstoniaSite Not Available
GSK Investigational Site
Tartu, 51014
EstoniaSite Not Available
GSK Investigational Site
Espoo, 02230
FinlandSite Not Available
GSK Investigational Site
Helsinki, 00930
FinlandSite Not Available
GSK Investigational Site
Jarvenpaa, 04400
FinlandSite Not Available
GSK Investigational Site
Kokkola, 67100
FinlandSite Not Available
GSK Investigational Site
Oulu, 90220
FinlandSite Not Available
GSK Investigational Site
Seinajoki, 60100
FinlandSite Not Available
GSK Investigational Site
Tampere, 33100
FinlandSite Not Available
GSK Investigational Site
Turku, 20520
FinlandSite Not Available
GSK Investigational Site
Berlin, 13347
GermanySite Not Available
GSK Investigational Site
Dachau, 85221
GermanySite Not Available
GSK Investigational Site
Dippoldiswalde, 01744
GermanySite Not Available
GSK Investigational Site
Dresden, 01279
GermanySite Not Available
GSK Investigational Site
Essen, 45355
GermanySite Not Available
GSK Investigational Site
Floersheim, 65439
GermanySite Not Available
GSK Investigational Site
Frankfurt, 60313
GermanySite Not Available
GSK Investigational Site
Freiberg, 09599
GermanySite Not Available
GSK Investigational Site
Freital, 01705
GermanySite Not Available
GSK Investigational Site
Goch, 47574
GermanySite Not Available
GSK Investigational Site
Hamburg, 22143
GermanySite Not Available
GSK Investigational Site
Hannover, 30159
GermanySite Not Available
GSK Investigational Site
Koeln, 51069
GermanySite Not Available
GSK Investigational Site
Leipzig, 04103
GermanySite Not Available
GSK Investigational Site
Mainz, 55116
GermanySite Not Available
GSK Investigational Site
Muenchen, 80339
GermanySite Not Available
GSK Investigational Site
Schenefeld, 22869
GermanySite Not Available
GSK Investigational Site
Wallerfing, 94574
GermanySite Not Available
GSK Investigational Site
Wangen, 88239
GermanySite Not Available
GSK Investigational Site
Weinheim, 69469
GermanySite Not Available
GSK Investigational Site
Witten, 58455
GermanySite Not Available
GSK Investigational Site
Wuerzburg, 97070
GermanySite Not Available
GSK Investigational Site
Alessandria, 15121
ItalySite Not Available
GSK Investigational Site
Bari, 70124
ItalySite Not Available
GSK Investigational Site
Belluno, 32100
ItalySite Not Available
GSK Investigational Site
Catanzaro, 88100
ItalySite Not Available
GSK Investigational Site
Ferrara, 44124
ItalySite Not Available
GSK Investigational Site
Napoli, 80131
ItalySite Not Available
GSK Investigational Site
Negrar Verona, 37024
ItalySite Not Available
GSK Investigational Site
Palermo, 90127
ItalySite Not Available
GSK Investigational Site
Pessione - Chieri TO, 10023
ItalySite Not Available
GSK Investigational Site
Pisa, 56126
ItalySite Not Available
GSK Investigational Site
Roma, 00128
ItalySite Not Available
GSK Investigational Site
Siena, 53100
ItalySite Not Available
GSK Investigational Site
Hiroshima, 732-0053
JapanSite Not Available
GSK Investigational Site
Ibaraki, 306-0041
JapanSite Not Available
GSK Investigational Site
Kumamoto, 860-0863
JapanSite Not Available
GSK Investigational Site
Okinawa, 901-2393
JapanSite Not Available
GSK Investigational Site
Saitama, 350-1122
JapanSite Not Available
GSK Investigational Site
Shizuoka, 421-0193
JapanSite Not Available
GSK Investigational Site
Tokyo, 160-0017
JapanActive - Recruiting
GSK Investigational Site
Yamagata, 990-0834
JapanSite Not Available
GSK Investigational Site
Yamaguchi, 750-0061
JapanSite Not Available
GSK Investigational Site
Ansan, 15355
Korea, Republic ofSite Not Available
GSK Investigational Site
Bucheon-si Kyunggi-do 14584, 14584
Korea, Republic ofSite Not Available
GSK Investigational Site
Daegu, 41944
Korea, Republic ofSite Not Available
GSK Investigational Site
Incheon, 400-711
Korea, Republic ofSite Not Available
GSK Investigational Site
Jeonju, 54907
Korea, Republic ofSite Not Available
GSK Investigational Site
Kangwon-do, 26426
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 08308
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon Gyeonggi-do, 442-723
Korea, Republic ofSite Not Available
GSK Investigational Site
Chihuahua, 31203
MexicoSite Not Available
GSK Investigational Site
Leon, 37530
MexicoSite Not Available
GSK Investigational Site
Merida, 97070
MexicoSite Not Available
GSK Investigational Site
Mexico City, 06760
MexicoSite Not Available
GSK Investigational Site
Monterrey, 64460
MexicoSite Not Available
GSK Investigational Site
Oaxaca, 68000
MexicoSite Not Available
GSK Investigational Site
Queretaro, 76070
MexicoSite Not Available
GSK Investigational Site
RM Pharmamexico CITY, 03100
MexicoSite Not Available
GSK Investigational Site
San Luis PotosI, 78209
MexicoSite Not Available
GSK Investigational Site
Grafton Auckland, 1010
New ZealandSite Not Available
GSK Investigational Site
Hawke's Bay, 4122
New ZealandSite Not Available
GSK Investigational Site
Kapiti, 5032
New ZealandSite Not Available
GSK Investigational Site
Palmerston North, 4414
New ZealandSite Not Available
GSK Investigational Site
Tauranga, 3110
New ZealandSite Not Available
GSK Investigational Site
Wellington, 6021
New ZealandSite Not Available
GSK Investigational Site
Czestochowa, 42-202
PolandSite Not Available
GSK Investigational Site
Elblag, 82-300
PolandSite Not Available
GSK Investigational Site
Gdansk, 80-382
PolandSite Not Available
GSK Investigational Site
Gdynia, 81-537
PolandSite Not Available
GSK Investigational Site
Katowice, 40-648
PolandSite Not Available
GSK Investigational Site
Krakow, 31-501
PolandSite Not Available
GSK Investigational Site
Lodz, 91-363
PolandSite Not Available
GSK Investigational Site
Poznan, 60-702
PolandSite Not Available
GSK Investigational Site
Warsaw, 03-291
PolandSite Not Available
GSK Investigational Site
Warszawa, 02-672
PolandSite Not Available
GSK Investigational Site
Wroclaw, 53-671
PolandSite Not Available
GSK Investigational Site
Barnaul, 656043
Russian FederationSite Not Available
GSK Investigational Site
Ekaterinburg, 620137
Russian FederationSite Not Available
GSK Investigational Site
Gatchina, 188300
Russian FederationSite Not Available
GSK Investigational Site
Kemerovo, 650066
Russian FederationSite Not Available
GSK Investigational Site
Moscow, 115478
Russian FederationSite Not Available
GSK Investigational Site
Saint-Petersburg, 196158
Russian FederationSite Not Available
GSK Investigational Site
StPetersburg, 191119
Russian FederationSite Not Available
GSK Investigational Site
Bloemfontein, 9300
South AfricaSite Not Available
GSK Investigational Site
Cape Town, 7700
South AfricaSite Not Available
GSK Investigational Site
Johannesburg, 2113
South AfricaSite Not Available
GSK Investigational Site
Middelburg, 1050
South AfricaSite Not Available
GSK Investigational Site
Moloto South, 1022
South AfricaSite Not Available
GSK Investigational Site
Reiger Park, 1459
South AfricaSite Not Available
GSK Investigational Site
Tembisa, 1632
South AfricaSite Not Available
GSK Investigational Site
AlcorcOn, 28922
SpainSite Not Available
GSK Investigational Site
Barcelona, 8025
SpainSite Not Available
GSK Investigational Site
Madrid, 28041
SpainSite Not Available
GSK Investigational Site
Santiago de Compostela, 15706
SpainSite Not Available
GSK Investigational Site
Valencia, 46020
SpainSite Not Available
GSK Investigational Site
Bradford on Avon, Wiltshire BA15 1DQ
United KingdomSite Not Available
GSK Investigational Site
Bebington, CH63 9JP
United KingdomSite Not Available
GSK Investigational Site
Belfast, BT2 8BG
United KingdomSite Not Available
GSK Investigational Site
Birmingham, B15 2SQ
United KingdomSite Not Available
GSK Investigational Site
Cardiff, CF15 9SS
United KingdomSite Not Available
GSK Investigational Site
Corby, NN17 2UR
United KingdomSite Not Available
GSK Investigational Site
Eynsham, OX29 4QB
United KingdomSite Not Available
GSK Investigational Site
Glasgow, ML4 3NJ
United KingdomSite Not Available
GSK Investigational Site
Hexham, NE46 1QJ
United KingdomSite Not Available
GSK Investigational Site
Lancashire, PR7 7NA
United KingdomSite Not Available
GSK Investigational Site
Leamington Spa, CV32 4RA
United KingdomSite Not Available
GSK Investigational Site
Liverpool, L22 0LG
United KingdomSite Not Available
GSK Investigational Site
Manchester, M15 6SE
United KingdomSite Not Available
GSK Investigational Site
Orpington, BR5 3QG
United KingdomSite Not Available
GSK Investigational Site
Oxford, OX4 1XB
United KingdomSite Not Available
GSK Investigational Site
Peterborough, PE8 6PL
United KingdomSite Not Available
GSK Investigational Site
Thetford, IP24 1JD
United KingdomSite Not Available
GSK Investigational Site
Witney, OX28 6JS
United KingdomSite Not Available
GSK Investigational Site
Birmingham, Alabama 35205
United StatesSite Not Available
GSK Investigational Site
Huntsville, Alabama 35802
United StatesSite Not Available
GSK Investigational Site
Phoenix, Arizona 85306
United StatesSite Not Available
GSK Investigational Site
Tucson, Arizona 85741
United StatesSite Not Available
GSK Investigational Site
Cerritos, California 90703
United StatesSite Not Available
GSK Investigational Site
Coral Gables, Florida 33134
United StatesSite Not Available
GSK Investigational Site
Fort Myers, Florida 33912
United StatesSite Not Available
GSK Investigational Site
Jacksonville, Florida 32205
United StatesSite Not Available
GSK Investigational Site
Lake City, Florida 32055
United StatesSite Not Available
GSK Investigational Site
Melbourne, Florida 32934
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33174
United StatesSite Not Available
GSK Investigational Site
Orlando, Florida 32806
United StatesSite Not Available
GSK Investigational Site
Pinellas Park, Florida 33781
United StatesSite Not Available
GSK Investigational Site
The Villages, Florida 32162
United StatesSite Not Available
GSK Investigational Site
West Palm Beach, Florida 33409
United StatesSite Not Available
GSK Investigational Site
Atlanta, Georgia 30328
United StatesSite Not Available
GSK Investigational Site
Savannah, Georgia 31406
United StatesSite Not Available
GSK Investigational Site
Chicago, Illinois 60602
United StatesSite Not Available
GSK Investigational Site
Evansville, Indiana 47714
United StatesSite Not Available
GSK Investigational Site
Mishawaka, Indiana 46544
United StatesSite Not Available
GSK Investigational Site
El Dorado, Kansas 67042
United StatesSite Not Available
GSK Investigational Site
Newton, Kansas 67114
United StatesSite Not Available
GSK Investigational Site
Wichita, Kansas 67207
United StatesSite Not Available
GSK Investigational Site
Lexington, Kentucky 40509
United StatesSite Not Available
GSK Investigational Site
Rockville, Maryland 20854
United StatesSite Not Available
GSK Investigational Site
Richfield, Minnesota 55423
United StatesSite Not Available
GSK Investigational Site
Kansas City, Missouri 64114
United StatesSite Not Available
GSK Investigational Site
Saint Louis, Missouri 63141
United StatesSite Not Available
GSK Investigational Site
Omaha, Nebraska 68134
United StatesSite Not Available
GSK Investigational Site
Henderson, Nevada 89052
United StatesSite Not Available
GSK Investigational Site
New York, New York 10017
United StatesSite Not Available
GSK Investigational Site
Rochester, New York 14609
United StatesSite Not Available
GSK Investigational Site
Hickory, North Carolina 28601
United StatesSite Not Available
GSK Investigational Site
Mooresville, North Carolina 28117
United StatesSite Not Available
GSK Investigational Site
Rocky Mount, North Carolina 27804
United StatesSite Not Available
GSK Investigational Site
Salisbury, North Carolina 28144
United StatesSite Not Available
GSK Investigational Site
Winston-Salem, North Carolina 27103
United StatesSite Not Available
GSK Investigational Site
Akron, Ohio 44311
United StatesSite Not Available
GSK Investigational Site
Centerville, Ohio 45459
United StatesSite Not Available
GSK Investigational Site
Cincinnati, Ohio 45236
United StatesSite Not Available
GSK Investigational Site
Columbus, Ohio 43212
United StatesSite Not Available
GSK Investigational Site
Erie, Pennsylvania 16508
United StatesSite Not Available
GSK Investigational Site
Pittsburgh, Pennsylvania 15236
United StatesSite Not Available
GSK Investigational Site
Anderson, South Carolina 29621
United StatesSite Not Available
GSK Investigational Site
Mount Pleasant, South Carolina 29405
United StatesSite Not Available
GSK Investigational Site
Knoxville, Tennessee 37938
United StatesSite Not Available
GSK Investigational Site
Memphis, Tennessee 38119
United StatesSite Not Available
GSK Investigational Site
Dallas, Texas 75234
United StatesSite Not Available
GSK Investigational Site
Fort Worth, Texas 76104
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77008
United StatesSite Not Available
GSK Investigational Site
Keller, Texas 76248
United StatesSite Not Available
GSK Investigational Site
San Antonio, Texas 78229
United StatesSite Not Available
GSK Investigational Site
Salt Lake City, Utah 84106
United StatesSite Not Available
GSK Investigational Site
Norfolk, Virginia 23502
United StatesSite Not Available
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