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
概览
- 阶段
- 3 期
- 干预措施
- RSVPreF3 OA investigational vaccine
- 疾病 / 适应症
- Respiratory Syncytial Virus Infections
- 发起方
- GlaxoSmithKline
- 入组人数
- 1720
- 试验地点
- 46
- 主要终点
- Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
RSV_1dose Group
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups: RSV\_1dose\_M36 (which will receive 1 additional revaccination dose at Month 36 and will be followed up until Month 60) and RSV\_1dose\_Flexible (which will receive 1 additional revaccination dose at Month 60, and will be followed up until study end at Month 72).
干预措施: RSVPreF3 OA investigational vaccine
RSV_annual Group
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until Month 60.
干预措施: RSVPreF3 OA investigational vaccine
RSV_Flexible revaccination Group
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until Month 60.
干预措施: RSVPreF3 OA investigational vaccine
结局指标
主要结局
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12
时间窗: At Month 12
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1
时间窗: At Day 1
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12
时间窗: At Month 12
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6
时间窗: At Month 6
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6
时间窗: At Month 6
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31
时间窗: At Day 31
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31
时间窗: At Day 31
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1
时间窗: At Day 1
RSV-A neutralizing antibodies were 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).
次要结局
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31(At Day 31)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12(At Month 12)
- Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18(At Month 18)
- Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13(At Month 13)
- Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24(At Month 24)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24(At Month 24)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6(At Month 6)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18(At Month 18)
- Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1(At Day 1)
- Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30(At Month 30)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13(At Month 13)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25(At Month 25)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12(At Month 12)
- Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18(At Month 18)
- Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36(At Month 36)
- Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25(At Month 25)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18(At Month 18)
- Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1(At Day 1)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1(At Day 1)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12(At Month 12)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6(At Month 6)
- Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24(At Month 24)
- Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30(At Month 30)
- Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36(At Month 36)
- Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25(At Month 25)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30(At Month 30)
- Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36(At Month 36)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31(At Day 31)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31(At Day 31)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13(At Month 13)
- Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13(At Month 13)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6(At Month 6)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18(At Month 18)
- Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1(During the 4-day follow up period after first vaccination (vaccine administered on Day 1))
- Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 24(During the 4-day follow up period after vaccination (vaccine administered at Month 24))
- Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1(During the 30-day follow up period after vaccination (vaccine administered on Day 1))
- Number of Participants With SAEs Following Vaccination at Month 12(During the 4-day follow up period after vaccination (vaccine administered at Month 12))
- Number of Participants Reporting Any pIMD Following Vaccination at Month 24(During the 4-day follow up period after vaccination (vaccine administered at Month 24))
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24(At Month 24)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30(At Month 30)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25(At Month 25)
- Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 12(During the 4-day follow up period after vaccination (vaccine administered at Month 12))
- Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1(During the 4-day follow up period after vaccination (vaccine administered on Day 1))
- Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 12(During the 4-day follow up period after vaccination (vaccine administered at Month 12))
- Number of Participants With Any Unsolicited AEs Following Vaccination at Month 24(During the 4-day follow up period after vaccination (vaccine administered at Month 24))
- Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1(From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6))
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30(At Month 30)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36(At Month 36)
- Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 24(During the 4-day follow up period after vaccination (vaccine administered at Month 24))
- Number of Participants With Any Unsolicited AEs Following Vaccination at Month 12(During the 4-day follow up period after vaccination (vaccine administered at Month 12))
- Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1(From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6))
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24(At Month 24)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25(At Month 25)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36(At Month 36)
- CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13(At Month 13)
- Number of Participants With SAEs Following Vaccination at Month 24(During the 4-day follow up period after vaccination (vaccine administered at Month 24))
- Number of Participants With a Fatal SAE, Related SAE and Related pIMDs(From first vaccination (Day 1) up to study end (Month 36))
- Number of Participants Reporting Any pIMD Following Vaccination at Month 12(During the 4-day follow up period after vaccination (vaccine administered at Month 12))