Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
NCT ID: NCT04886596
Last Updated: 2025-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
26675 participants
INTERVENTIONAL
2021-05-25
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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RSVPreF3 Group
Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study.
RSVPreF3 OA vaccine
RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV\_annual group.
Placebo Group
Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.
Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before Season 2 to the Placebo Group, and before Season 2 to the participants of the RSVPreF3 Group, that are re-randomized to the RSV\_1 dose group.
Interventions
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Placebo
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before Season 2 to the Placebo Group, and before Season 2 to the participants of the RSVPreF3 Group, that are re-randomized to the RSV\_1 dose group.
RSVPreF3 OA vaccine
RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV\_annual group.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Cerritos, California, United States
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Laguna Hills, California, United States
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Coral Gables, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Lake City, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pinellas Park, Florida, United States
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The Villages, Florida, United States
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Weeki Wachee, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Mishawaka, Indiana, United States
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El Dorado, Kansas, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Rockville, Maryland, United States
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Richfield, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Binghamton, New York, United States
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Jamaica, New York, United States
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Rochester, New York, United States
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Hickory, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Centerville, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Erie, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Anderson, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Keller, Texas, United States
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San Antonio, Texas, United States
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Layton, Utah, United States
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Murray, Utah, United States
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Norfolk, Virginia, United States
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Botany, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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Morayfield, Queensland, Australia
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Taringa, Queensland, Australia
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Tarragindi, Queensland, Australia
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Camberwell, Victoria, Australia
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Geelong, Victoria, Australia
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Spearwood, Western Australia, Australia
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Aalst, , Belgium
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Alken, , Belgium
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Edegem, , Belgium
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Erpent, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Ieper, , Belgium
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Linkebeek, , Belgium
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Linkebeek, , Belgium
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Linkebeek, , Belgium
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Linkebeek, , Belgium
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Linkebeek, , Belgium
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Linkebeek, , Belgium
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Mechelen, , Belgium
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Tremelo, , Belgium
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Edmonton, Alberta, Canada
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New Westminster, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Truro, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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London-Ontario, Ontario, Canada
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Ottawa, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Mirabel, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Paide, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Espoo, , Finland
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Helsinki, , Finland
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Helsinki, , Finland
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Järvenpää, , Finland
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Kokkola, , Finland
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Oulu, , Finland
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Pori, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Freiberg, Saxony, Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Dachau, , Germany
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Dippoldiswalde, , Germany
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Dresden, , Germany
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Essen, , Germany
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Essen, , Germany
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Flörsheim, , Germany
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Frankfurt, , Germany
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Freital, , Germany
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Goch, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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München, , Germany
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Schenefeld, , Germany
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Wallerfing, , Germany
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Wangen, , Germany
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Weinheim, , Germany
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Witten, , Germany
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Würzburg, , Germany
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Alessandria, , Italy
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Bari, , Italy
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Belluno, , Italy
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Catanzaro, , Italy
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Chieri Torino, , Italy
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Ferrara, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Negrar Verona, , Italy
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Palermo, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Siena, , Italy
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Vercelli, , Italy
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Chiba, , Japan
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Hiroshima, , Japan
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Ibaraki, , Japan
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Kumamoto, , Japan
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Okinawa, , Japan
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Osaka, , Japan
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Saitama, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Yamagata, , Japan
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Yamaguchi, , Japan
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Chihuahua City, , Mexico
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León, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Oaxaca City, , Mexico
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Querétaro, , Mexico
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RM Pharmamexico CITY, , Mexico
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San Luis Potosí City, , Mexico
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Grafton Auckland, , New Zealand
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Havelock North, , New Zealand
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Kapiti, , New Zealand
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Palmerston North, , New Zealand
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Tauranga, , New Zealand
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Wellington, , New Zealand
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Częstochowa, , Poland
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Elblag, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Piaseczno, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Barnaul, , Russia
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Gatchina, , Russia
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Kemerovo, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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StPetersburg, , Russia
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StPetersburg, , Russia
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Yekaterinburg, , Russia
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Middelburg, , South Africa
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Moloto South, , South Africa
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Newcastle, , South Africa
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Reiger Park, , South Africa
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Tembisa, , South Africa
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Ansan, , South Korea
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Bucheon-si Kyunggi-do 14584, , South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Jeonju, , South Korea
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Kangwon-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon Gyeonggi-do, , South Korea
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Alcorcón, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Bebington, , United Kingdom
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Belfast, , United Kingdom
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Birmingham, , United Kingdom
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Bradford on Avon Wiltsh, , United Kingdom
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Cardiff, , United Kingdom
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Corby, , United Kingdom
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Eynsham, , United Kingdom
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Glasgow, , United Kingdom
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Hardwick, , United Kingdom
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Hexham, , United Kingdom
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Lancashire, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
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Orpington, , United Kingdom
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Oxford, , United Kingdom
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Peterborough, , United Kingdom
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Romford, , United Kingdom
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Royal Leamington Spa, , United Kingdom
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Thetford Norfolk, , United Kingdom
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Witney, , United Kingdom
Countries
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References
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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.
Ison MG, Papi A, Athan E, Feldman RG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Cuadripani S, Deraedt Q, Dezutter N, Gerard C, Fissette L, Xavier S, David MP, Olivier A, Van der Wielen M, Descamps D; AReSVi-006 study group. Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial. Lancet Respir Med. 2025 Jun;13(6):517-529. doi: 10.1016/S2213-2600(25)00048-7. Epub 2025 Apr 14.
Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Durocher Y. CHO cells for virus-like particle and subunit vaccine manufacturing. Vaccine. 2024 Apr 11;42(10):2530-2542. doi: 10.1016/j.vaccine.2024.03.034. Epub 2024 Mar 19.
Kurai D, Mizukami A, Preckler V, Verelst F, Molnar D, Matsuki T, Ho Y, Igarashi A. The potential public health impact of the respiratory syncytial virus prefusion F protein vaccine in people aged >/=60 years in Japan: results of a Markov model analysis. Expert Rev Vaccines. 2024 Jan-Dec;23(1):303-311. doi: 10.1080/14760584.2024.2323128. Epub 2024 Mar 1.
Curran D, Matthews S, Cabrera ES, Perez SN, Breva LP, Ramet M, Helman L, Park DW, Schwarz TF, Melendez IMG, Schaefer A, Roy N, Stephan B, Molnar D, Kostanyan L, Powers JH 3rd, Hulstrom V; Members of the AReSVi-006 Study Group. The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults >/=60 years of age. Influenza Other Respir Viruses. 2024 Feb 3;18(2):e13236. doi: 10.1111/irv.13236. eCollection 2024 Feb.
Feldman RG, Antonelli-Incalzi R, Steenackers K, Lee DG, Papi A, Ison MG, Fissette L, David MP, Marechal C, Van der Wielen M, Kostanyan L, Hulstrom V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine Is Efficacious in Older Adults With Underlying Medical Conditions. Clin Infect Dis. 2024 Jan 25;78(1):202-209. doi: 10.1093/cid/ciad471.
Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrom V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-000753-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
212494
Identifier Type: -
Identifier Source: org_study_id
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