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

Last updated: August 2, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

RSVPreF3 OA vaccine

Clinical Study ID

NCT06534892
222090
2023-509762-38-00
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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

Total Participants: 12000
Treatment Group(s): 1
Primary Treatment: RSVPreF3 OA vaccine
Phase: 3
Study Start date:
August 01, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • GSK Investigational Site

    Botany, 2019
    Australia

    Site Not Available

  • GSK Investigational Site

    Camberwell, 3124
    Australia

    Site Not Available

  • GSK Investigational Site

    Coffs Harbour, 2450
    Australia

    Site Not Available

  • GSK Investigational Site

    Darlinghurst, 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Geelong, 3220
    Australia

    Site Not Available

  • GSK Investigational Site

    Murdoch, 6163
    Australia

    Site Not Available

  • GSK Investigational Site

    Taringa, 4068
    Australia

    Site Not Available

  • GSK Investigational Site

    Tarragindi, 4121
    Australia

    Site Not Available

  • GSK Investigational Site

    Alken, 3570
    Belgium

    Site Not Available

  • GSK Investigational Site

    Edegem, 2610
    Belgium

    Site Not Available

  • GSK Investigational Site

    Erpent, 5101
    Belgium

    Site Not Available

  • GSK Investigational Site

    Genk, 3600
    Belgium

    Site Not Available

  • GSK Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Ieper, 8900
    Belgium

    Site Not Available

  • GSK Investigational Site

    Linkebeek, 3544
    Belgium

    Site Not Available

  • GSK Investigational Site

    Mechelen, 2800
    Belgium

    Site Not Available

  • GSK Investigational Site

    Tremelo, 3120
    Belgium

    Site Not Available

  • GSK Investigational Site

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • GSK Investigational Site

    Chicoutimi, G7H 7Y8
    Canada

    Site Not Available

  • GSK Investigational Site

    Edmonton, T5A 4L8
    Canada

    Site Not Available

  • GSK Investigational Site

    Halifax, B3J 3G9
    Canada

    Site Not Available

  • GSK Investigational Site

    London-Ontario, N5W 6A2
    Canada

    Site Not Available

  • GSK Investigational Site

    Mirabel, J7J 2K8
    Canada

    Site Not Available

  • GSK Investigational Site

    New Westminster, V3L 3W4
    Canada

    Site Not Available

  • GSK Investigational Site

    Ottawa, K1H 8L6
    Canada

    Site Not Available

  • GSK Investigational Site

    Pointe-Claire, H9R4S3
    Canada

    Site Not Available

  • GSK Investigational Site

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • GSK Investigational Site

    Sainte-Foy, G1E 7G9
    Canada

    Site Not Available

  • GSK Investigational Site

    Sarnia, N7T 4X3
    Canada

    Site Not Available

  • GSK Investigational Site

    Sherbrooke, J1J 2G2
    Canada

    Site Not Available

  • GSK Investigational Site

    St-Charles-Borromee, J6E 2B4
    Canada

    Site Not Available

  • GSK Investigational Site

    Sudbury, P3C 1X3
    Canada

    Site Not Available

  • GSK Investigational Site

    Surrey, V3S 2N6
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, M9W 4L6
    Canada

    Site Not Available

  • GSK Investigational Site

    Truro, B2N 1L2
    Canada

    Site Not Available

  • GSK Investigational Site

    Vancouver, V6Z 2T1
    Canada

    Site Not Available

  • GSK Investigational Site

    Victoria, V8V 3M9
    Canada

    Site Not Available

  • GSK Investigational Site

    Paide, 72713
    Estonia

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  • GSK Investigational Site

    Tallinn, 10128
    Estonia

    Site Not Available

  • GSK Investigational Site

    Tartu, 51014
    Estonia

    Site Not Available

  • GSK Investigational Site

    Espoo, 02230
    Finland

    Site Not Available

  • GSK Investigational Site

    Helsinki, 00930
    Finland

    Site Not Available

  • GSK Investigational Site

    Jarvenpaa, 04400
    Finland

    Site Not Available

  • GSK Investigational Site

    Kokkola, 67100
    Finland

    Site Not Available

  • GSK Investigational Site

    Oulu, 90220
    Finland

    Site Not Available

  • GSK Investigational Site

    Seinajoki, 60100
    Finland

    Site Not Available

  • GSK Investigational Site

    Tampere, 33100
    Finland

    Site Not Available

  • GSK Investigational Site

    Turku, 20520
    Finland

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  • GSK Investigational Site

    Berlin, 13347
    Germany

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    Dachau, 85221
    Germany

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  • GSK Investigational Site

    Dippoldiswalde, 01744
    Germany

    Site Not Available

  • GSK Investigational Site

    Dresden, 01279
    Germany

    Site Not Available

  • GSK Investigational Site

    Essen, 45355
    Germany

    Site Not Available

  • GSK Investigational Site

    Floersheim, 65439
    Germany

    Site Not Available

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    Frankfurt, 60313
    Germany

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  • GSK Investigational Site

    Freiberg, 09599
    Germany

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    Freital, 01705
    Germany

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    Goch, 47574
    Germany

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    Hamburg, 22143
    Germany

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    Hannover, 30159
    Germany

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    Koeln, 51069
    Germany

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    Leipzig, 04103
    Germany

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    Mainz, 55116
    Germany

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    Muenchen, 80339
    Germany

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    Schenefeld, 22869
    Germany

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    Wallerfing, 94574
    Germany

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    Wangen, 88239
    Germany

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    Weinheim, 69469
    Germany

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    Witten, 58455
    Germany

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    Wuerzburg, 97070
    Germany

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    Alessandria, 15121
    Italy

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    Bari, 70124
    Italy

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    Belluno, 32100
    Italy

    Site Not Available

  • GSK Investigational Site

    Catanzaro, 88100
    Italy

    Site Not Available

  • GSK Investigational Site

    Ferrara, 44124
    Italy

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    Napoli, 80131
    Italy

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  • GSK Investigational Site

    Negrar Verona, 37024
    Italy

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    Palermo, 90127
    Italy

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    Pessione - Chieri TO, 10023
    Italy

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    Pisa, 56126
    Italy

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    Roma, 00128
    Italy

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    Siena, 53100
    Italy

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    Hiroshima, 732-0053
    Japan

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    Ibaraki, 306-0041
    Japan

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    Kumamoto, 860-0863
    Japan

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    Okinawa, 901-2393
    Japan

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  • GSK Investigational Site

    Saitama, 350-1122
    Japan

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  • GSK Investigational Site

    Shizuoka, 421-0193
    Japan

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  • GSK Investigational Site

    Tokyo, 160-0017
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Yamagata, 990-0834
    Japan

    Site Not Available

  • GSK Investigational Site

    Yamaguchi, 750-0061
    Japan

    Site Not Available

  • GSK Investigational Site

    Ansan, 15355
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Bucheon-si Kyunggi-do 14584, 14584
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Incheon, 400-711
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Jeonju, 54907
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Kangwon-do, 26426
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442-723
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Chihuahua, 31203
    Mexico

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  • GSK Investigational Site

    Leon, 37530
    Mexico

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  • GSK Investigational Site

    Merida, 97070
    Mexico

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  • GSK Investigational Site

    Mexico City, 06760
    Mexico

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  • GSK Investigational Site

    Monterrey, 64460
    Mexico

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  • GSK Investigational Site

    Oaxaca, 68000
    Mexico

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  • GSK Investigational Site

    Queretaro, 76070
    Mexico

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  • GSK Investigational Site

    RM Pharmamexico CITY, 03100
    Mexico

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  • GSK Investigational Site

    San Luis PotosI, 78209
    Mexico

    Site Not Available

  • GSK Investigational Site

    Grafton Auckland, 1010
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Hawke's Bay, 4122
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Kapiti, 5032
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Palmerston North, 4414
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Tauranga, 3110
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Wellington, 6021
    New Zealand

    Site Not Available

  • GSK Investigational Site

    Czestochowa, 42-202
    Poland

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  • GSK Investigational Site

    Elblag, 82-300
    Poland

    Site Not Available

  • GSK Investigational Site

    Gdansk, 80-382
    Poland

    Site Not Available

  • GSK Investigational Site

    Gdynia, 81-537
    Poland

    Site Not Available

  • GSK Investigational Site

    Katowice, 40-648
    Poland

    Site Not Available

  • GSK Investigational Site

    Krakow, 31-501
    Poland

    Site Not Available

  • GSK Investigational Site

    Lodz, 91-363
    Poland

    Site Not Available

  • GSK Investigational Site

    Poznan, 60-702
    Poland

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  • GSK Investigational Site

    Warsaw, 03-291
    Poland

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  • GSK Investigational Site

    Warszawa, 02-672
    Poland

    Site Not Available

  • GSK Investigational Site

    Wroclaw, 53-671
    Poland

    Site Not Available

  • GSK Investigational Site

    Barnaul, 656043
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Ekaterinburg, 620137
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Gatchina, 188300
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Moscow, 115478
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Saint-Petersburg, 196158
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    StPetersburg, 191119
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Bloemfontein, 9300
    South Africa

    Site Not Available

  • GSK Investigational Site

    Cape Town, 7700
    South Africa

    Site Not Available

  • GSK Investigational Site

    Johannesburg, 2113
    South Africa

    Site Not Available

  • GSK Investigational Site

    Middelburg, 1050
    South Africa

    Site Not Available

  • GSK Investigational Site

    Moloto South, 1022
    South Africa

    Site Not Available

  • GSK Investigational Site

    Reiger Park, 1459
    South Africa

    Site Not Available

  • GSK Investigational Site

    Tembisa, 1632
    South Africa

    Site Not Available

  • GSK Investigational Site

    AlcorcOn, 28922
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 8025
    Spain

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  • GSK Investigational Site

    Madrid, 28041
    Spain

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  • GSK Investigational Site

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46020
    Spain

    Site Not Available

  • GSK Investigational Site

    Bradford on Avon, Wiltshire BA15 1DQ
    United Kingdom

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  • GSK Investigational Site

    Bebington, CH63 9JP
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Belfast, BT2 8BG
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Birmingham, B15 2SQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cardiff, CF15 9SS
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Corby, NN17 2UR
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Eynsham, OX29 4QB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Glasgow, ML4 3NJ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Hexham, NE46 1QJ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Lancashire, PR7 7NA
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Leamington Spa, CV32 4RA
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Liverpool, L22 0LG
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Manchester, M15 6SE
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Orpington, BR5 3QG
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Oxford, OX4 1XB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Peterborough, PE8 6PL
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Thetford, IP24 1JD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Witney, OX28 6JS
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • GSK Investigational Site

    Huntsville, Alabama 35802
    United States

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85306
    United States

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  • GSK Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • GSK Investigational Site

    Cerritos, California 90703
    United States

    Site Not Available

  • GSK Investigational Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • GSK Investigational Site

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • GSK Investigational Site

    Lake City, Florida 32055
    United States

    Site Not Available

  • GSK Investigational Site

    Melbourne, Florida 32934
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33174
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • GSK Investigational Site

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • GSK Investigational Site

    The Villages, Florida 32162
    United States

    Site Not Available

  • GSK Investigational Site

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • GSK Investigational Site

    Savannah, Georgia 31406
    United States

    Site Not Available

  • GSK Investigational Site

    Chicago, Illinois 60602
    United States

    Site Not Available

  • GSK Investigational Site

    Evansville, Indiana 47714
    United States

    Site Not Available

  • GSK Investigational Site

    Mishawaka, Indiana 46544
    United States

    Site Not Available

  • GSK Investigational Site

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • GSK Investigational Site

    Newton, Kansas 67114
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • GSK Investigational Site

    Rockville, Maryland 20854
    United States

    Site Not Available

  • GSK Investigational Site

    Richfield, Minnesota 55423
    United States

    Site Not Available

  • GSK Investigational Site

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • GSK Investigational Site

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • GSK Investigational Site

    Henderson, Nevada 89052
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10017
    United States

    Site Not Available

  • GSK Investigational Site

    Rochester, New York 14609
    United States

    Site Not Available

  • GSK Investigational Site

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • GSK Investigational Site

    Mooresville, North Carolina 28117
    United States

    Site Not Available

  • GSK Investigational Site

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • GSK Investigational Site

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • GSK Investigational Site

    Akron, Ohio 44311
    United States

    Site Not Available

  • GSK Investigational Site

    Centerville, Ohio 45459
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Ohio 43212
    United States

    Site Not Available

  • GSK Investigational Site

    Erie, Pennsylvania 16508
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • GSK Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • GSK Investigational Site

    Mount Pleasant, South Carolina 29405
    United States

    Site Not Available

  • GSK Investigational Site

    Knoxville, Tennessee 37938
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75234
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77008
    United States

    Site Not Available

  • GSK Investigational Site

    Keller, Texas 76248
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • GSK Investigational Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

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