Clinical trial NCT04886596: Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Official title: A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory syncytial virus
Lower respiratory tract disease
Efficacy study
Adults aged 60 years and above
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 26668
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

Detailed description: Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1.

Eligibility criteria: Inclusion Criteria:

* A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF participants).
* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant

* 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 the time of first vaccination. 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 if considered by the investigator as medically stable.

Exclusion Criteria:

Medical conditions

* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Hypersensitivity to latex.
* Serious or unstable chronic illness.
* Any history of dementia or any medical condition that moderately or severely impairs cognition.

Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.

* Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

Prior/Concomitant therapy

* Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, or planned use during the study period.
* Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
* Previous vaccination with an RSV vaccine.
* Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study vaccine or planned administration during the study period.
* Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccine administration or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

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 (drug or medical device).

Other exclusions

* History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
* Bedridden participants.
* Planned move during the study period that will prohibit participating in the trial until study end. This includes:

  * Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
  * Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
* Participation of any study personnel or their immediate dependants, family, or household members.
* Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons\* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.

  * RSV seasons are from October to April in NH and from March to September in SH.

Primary outcomes:
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
timeFrame: From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant]
Secondary outcomes:
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
timeFrame: From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemishpere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
timeFrame: From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
timeFrame: From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 3 years in the NH and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
timeFrame: From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
timeFrame: From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
timeFrame: From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first-vaccination or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination)
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first and each revaccination dose to the first occurrence of RSV severe LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Acute Respiratory Illness (ARI) Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first and each revaccination dose to first occurrence of RSV ARI (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From Day 15 post first vaccination up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
measure: Number of Hospitalizations Due to Respiratory Diseases or Due to a Complication Related to Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
measure: Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
measure: Number of Complications Related to ARI and RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
measure: Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
measure: Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
measure: EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: At the ARI visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
measure: Short Form-12 (SF-12) Physical Functioning Score for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
timeFrame: At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
measure: Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes
timeFrame: Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B ARI Episodes
timeFrame: Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B LRTD Episodes
timeFrame: Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity
timeFrame: Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
measure: RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
timeFrame: At Day 1 (Pre-Dose 1) and Day 31
measure: RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
timeFrame: Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
measure: RSV A Neutralizing Antibody Titers
timeFrame: At Day 1 (Pre-Dose 1) and Day 31
measure: RSV A Neutralizing Antibody Titers
timeFrame: Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
measure: RSV B Neutralizing Antibody Titers
timeFrame: At Day 1 (Pre-Dose 1) and Day 31
measure: RSV B Neutralizing Antibody Titers
timeFrame: Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
measure: Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
timeFrame: During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
measure: Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
timeFrame: During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
measure: Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
timeFrame: During the 4-day follow up period after the third vaccination (administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
measure: Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
timeFrame: During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
measure: Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
timeFrame: During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
measure: Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
timeFrame: During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere)
measure: Number of Days With Solicited Administration Site Adverse Events
timeFrame: During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
measure: Number of Days With Solicited Administration Site Adverse Events
timeFrame: During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
measure: Number of Days With Solicited Administration Site Adverse Events
timeFrame: During the 4-day follow up period after third vaccination (vaccine administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
measure: Number of Days With Solicited Systemic Adverse Events
timeFrame: During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
measure: Number of Days With Solicited Systemic Adverse Events
timeFrame: During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
measure: Number of Days With Solicited Systemic Adverse Events
timeFrame: During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
measure: Number of Participants With Any Unsolicited AEs
timeFrame: During the 30-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
measure: Number of Participants With Any Unsolicited AEs
timeFrame: During the 30-day follow up period after second vaccination (vaccine administered pre-season 2)
measure: Number of Participants With Any Unsolicited AEs
timeFrame: During the 30-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
measure: Number of Participants With Potential Immune Mediated Diseases (pIMDs)
timeFrame: From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
measure: Number of Participants With Related SAEs and Fatal SAEs
timeFrame: From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
measure: Number of Participants With Related pIMDs
timeFrame: From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Other outcomes:
Locations:
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city: Atlanta
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state: Illinois
city: Evansville
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city: Tallinn
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city: Tallinn
country: Estonia
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city: Espoo
country: Finland
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city: Helsinki
country: Finland
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city: Helsinki
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city: Jarvenpaa
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country: Finland
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city: Berlin
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city: Berlin
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country: Germany
facility: GSK Investigational Site
city: Dippoldiswalde
country: Germany
facility: GSK Investigational Site
city: Dresden
country: Germany
facility: GSK Investigational Site
city: Essen
country: Germany
facility: GSK Investigational Site
city: Essen
country: Germany
facility: GSK Investigational Site
city: Floersheim
country: Germany
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
city: Freiberg
country: Germany
facility: GSK Investigational Site
city: Freital
country: Germany
facility: GSK Investigational Site
city: Goch
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hannover
country: Germany
facility: GSK Investigational Site
city: Koeln
country: Germany
facility: GSK Investigational Site
city: Leipzig
country: Germany
facility: GSK Investigational Site
city: Leipzig
country: Germany
facility: GSK Investigational Site
city: Mainz
country: Germany
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
city: Schenefeld
country: Germany
facility: GSK Investigational Site
city: Wallerfing
country: Germany
facility: GSK Investigational Site
city: Wangen
country: Germany
facility: GSK Investigational Site
city: Weinheim
country: Germany
facility: GSK Investigational Site
city: Witten
country: Germany
facility: GSK Investigational Site
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
city: Alessandria
country: Italy
facility: GSK Investigational Site
city: Bari
country: Italy
facility: GSK Investigational Site
city: Belluno
country: Italy
facility: GSK Investigational Site
city: Catanzaro
country: Italy
facility: GSK Investigational Site
city: Chieri Torino
country: Italy
facility: GSK Investigational Site
city: Ferrara
country: Italy
facility: GSK Investigational Site
city: Genova
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Napoli
country: Italy
facility: GSK Investigational Site
city: Negrar Verona
country: Italy
facility: GSK Investigational Site
city: Palermo
country: Italy
facility: GSK Investigational Site
city: Pisa
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Siena
country: Italy
facility: GSK Investigational Site
city: Vercelli
country: Italy
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Okinawa
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Yamagata
country: Japan
facility: GSK Investigational Site
city: Yamaguchi
country: Japan
facility: GSK Investigational Site
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon-si Kyunggi-do 14584
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju
country: Korea, Republic of
facility: GSK Investigational Site
city: Kangwon-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Leon
country: Mexico
facility: GSK Investigational Site
city: Merida
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
city: Oaxaca
country: Mexico
facility: GSK Investigational Site
city: Queretaro
country: Mexico
facility: GSK Investigational Site
city: RM Pharmamexico CITY
country: Mexico
facility: GSK Investigational Site
city: San Luis PotosI
country: Mexico
facility: GSK Investigational Site
city: Grafton Auckland
country: New Zealand
facility: GSK Investigational Site
city: Havelock North
country: New Zealand
facility: GSK Investigational Site
city: Kapiti
country: New Zealand
facility: GSK Investigational Site
city: Palmerston North
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Czestochowa
country: Poland
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Piaseczno
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Barnaul
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Gatchina
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: StPetersburg
country: Russian Federation
facility: GSK Investigational Site
city: StPetersburg
country: Russian Federation
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Middelburg
country: South Africa
facility: GSK Investigational Site
city: Moloto South
country: South Africa
facility: GSK Investigational Site
city: Newcastle
country: South Africa
facility: GSK Investigational Site
city: Reiger Park
country: South Africa
facility: GSK Investigational Site
city: Tembisa
country: South Africa
facility: GSK Investigational Site
city: Alcorcon
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Bebington
country: United Kingdom
facility: GSK Investigational Site
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Bradford On Avon Wiltsh
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Corby
country: United Kingdom
facility: GSK Investigational Site
city: Eynsham
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Hardwick
country: United Kingdom
facility: GSK Investigational Site
city: Hexham
country: United Kingdom
facility: GSK Investigational Site
city: Lancashire
country: United Kingdom
facility: GSK Investigational Site
city: Leamington Spa
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Orpington
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Peterborough
country: United Kingdom
facility: GSK Investigational Site
city: Romford
country: United Kingdom
facility: GSK Investigational Site
city: Thetford Norfolk
country: United Kingdom
facility: GSK Investigational Site
city: Witney
country: United Kingdom
facility: GSK Investigational Site
Study officials:
References:
citation: Ison MG, Papi A, Athan E, Feldman RG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Verheust C, Dezutter N, Gruselle O, Fissette L, David MP, Kostanyan L, Hulstrom V, Olivier A, Van der Wielen M, Descamps D; AReSVi-006 Study Group. Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons. Clin Infect Dis. 2024 Jun 14;78(6):1732-1744. doi: 10.1093/cid/ciae010.