Clinical Trials List
Protocol Number212496 (RSV OA=ADJ-004)
NCT Number(ClinicalTrials.gov Identfier)NCT04732871
Active
2021-01-01 - 2025-06-30
Phase III
Recruiting5
Terminated2
ICD-10B97.4
Respiratory syncytial virus as the cause of diseases classified elsewhere
ICD-9079.6
Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site
A Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above
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Trial Applicant
GlaxoSmithKline
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Sponsor
GlaxoSmithKline
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzeng-Ji Chen NA
- Fu-Der Wang NA
- 黃惠君 NA
- 劉瑞瑤 未分科
- YI-TSUNG LIN NA
- Ling Ju Huang NA
- 黃信彰 NA
- 林宜璁 NA
- Yuh-Min Chen NA
- 楊盈盈 NA
- 葉恆良 NA
- Hsin-Kuo Ko NA
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chong-Jen Yu NA
- Shih-Chi Ku NA
- 陳人豪 NA
- 錢穎群 NA
- 江君揚 NA
- 郭書𡵓 NA
- Ping-Hung Kuo NA
- 許嘉林 NA
- 詹鼎正 NA
- CHIH-YUAN WANG 無
- 賀立婷 NA
- 廖庭淯 NA
- 郭律成 NA
- 阮聖元 NA
- 楊景堯 NA
- 吳婉禎 NA
- CHIH-YUAN WANG CHIH-YUAN WANG NA
- 蘇冠名 NA
- 鄭之勛 NA
- Jung-Yien Chien NA
- 黃俊凱 NA
- 張恬君 NA
- 張凌愷 NA
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih Hsueh Lin NA
- Jen-Wei Chou NA
- Hsiang-Han Kao NA
- Wen-Yuan Lin NA
- 朱家聲 NA
- 陳怡儒 NA
- Yi-Ting Hsu NA
- 廖偉志 NA
- 郭慧亮 NA
- Hsueh-Chou Lai NA
- Po-Tsung Huang NA
- 王牧羣 NA
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 翁碩駿 NA
- CHENG-HSU CHEN NA
- 傅家保 NA
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Respiratory Syncytial Virus Infections
Objectives
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 3 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Test Drug
RSVPreF3 OA investigational vaccine
Active Ingredient
RSVPreF3 OA investigational vaccine
Dosage Form
IM
Dosage
NA
Endpoints
Primary Outcome Measures :
Humoral immune response in terms of RSV-A neutralizing antibody Geometric Mean Titers (GMTs) [ Time Frame: At Day 1 (pre-vaccination) ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Day 31 ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Month 6 ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Month 12 ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Day 1 (pre-vaccination) ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Day 31 ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Month 6 ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Month 12 ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-A neutralizing antibody Geometric Mean Titers (GMTs) [ Time Frame: At Day 1 (pre-vaccination) ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Day 31 ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Month 6 ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-A neutralizing antibody GMTs [ Time Frame: At Month 12 ]
RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Day 1 (pre-vaccination) ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Day 31 ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Month 6 ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Humoral immune response in terms of RSV-B neutralizing antibody titers [ Time Frame: At Month 12 ]
RSV-B neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)
Inclution Criteria
Inclusion Criteria:
Male or female participants ≥60 YOA at first vaccination, who live in the community (CD 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.
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. Patients 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.
Male or female participants ≥60 YOA at first vaccination, who live in the community (CD 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.
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. Patients 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
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.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Serious or unstable chronic illness.
Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or 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.
Any history of dementia or any medical condition that moderately or severely impairs cognition.
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.
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, split virion 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 dose of 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 vaccine dose 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.
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 participation in the trial until the 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.
Medical conditions
Any confirmed or suspected 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 vaccine.
Hypersensitivity to latex.
Serious or unstable chronic illness.
Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or 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.
Any history of dementia or any medical condition that moderately or severely impairs cognition.
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.
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, split virion 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 dose of 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 vaccine dose 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.
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 participation in the trial until the 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.
The Estimated Number of Participants
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Taiwan
350 participants
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Global
1650 participants
