A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
NCT ID: NCT05966090
Last Updated: 2025-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
530 participants
INTERVENTIONAL
2023-07-28
2024-07-29
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
NONE
Study Groups
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Co-administration Group
Participants received both herpes zoster recombinant subunit (HZ/su) vaccine and respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine on Day 1 followed by second dose of HZ/su vaccine on Day 61.
RSVPreF3 OA investigational vaccine
One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
HZ/su vaccine
Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.
Control Group
Participants received HZ/su vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31 followed by second dose of HZ/su vaccine on Day 61.
RSVPreF3 OA investigational vaccine
One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
HZ/su vaccine
Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.
Interventions
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RSVPreF3 OA investigational vaccine
One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
HZ/su vaccine
Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female participants of non-childbearing potential may be enrolled in the study.
* Female participants of childbearing potential may be enrolled in the study, if the participant:
* has practiced adequate contraception from 1 month prior to study intervention administration.
* has a negative pregnancy test on the day of and prior to study intervention administration.
* has agreed to continue effective contraception until the end of the study.
* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed informed consent obtained from the participant prior to any study specific procedure being performed.
* Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
* Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.
Exclusion Criteria
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component.
* History of Guillain-Barré syndrome.
* Any history of dementia or any medical condition that moderately or severely impairs cognition.
* Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic 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.
* Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster.
* History of previous vaccination with any licensed or investigational recombinant adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned receipt through study participation.
* History of previous vaccination with any licensed or investigational live herpes zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
* Previous vaccination with licensed or investigational RSV vaccine.
* Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their 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 the first study intervention administration and ending 30 days after the last study intervention administration.
o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided COVID-19 vaccine use is in line with local governmental recommendations.
* Planned or actual administration of adjuvanted quadrivalent influenza vaccine influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration.
* Administration of long-acting immune-modifying drugs during the period starting 180 days before the administration of first dose of study interventions or planned administration at any time during the study period (e.g., infliximab).
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions 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 intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled, topical or intra-articular steroids are allowed.
* 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 (IMP) (drug or invasive medical device).
* 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 conduct that prohibits participation until study end.
* Participation of any study personnel or their immediate dependents, family, or household members.
50 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Daphne, Alabama, United States
GSK Investigational Site
Tempe, Arizona, United States
GSK Investigational Site
Corte Madera, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
North Miami Beach, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Columbus, Georgia, United States
GSK Investigational Site
Versailles, Kentucky, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Brampton, Ontario, Canada
GSK Investigational Site
Guelph, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Brampton, , Canada
GSK Investigational Site
Guelph, , Canada
GSK Investigational Site
Québec, , Canada
GSK Investigational Site
Québec, , Canada
GSK Investigational Site
Québec, , Canada
GSK Investigational Site
Québec, , Canada
GSK Investigational Site
Sarnia, , Canada
GSK Investigational Site
Sherbrooke, , Canada
GSK Investigational Site
Toronto, , Canada
GSK Investigational Site
Toronto, , Canada
GSK Investigational Site
Toronto, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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219331
Identifier Type: -
Identifier Source: org_study_id
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