| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Volunteers (Active immunisation for the prevention of disease caused by respiratory syncytial virus (RSV) in adults aged 60 years or above) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Respiratory tract infection caused by respiratory syncytial virus (RSV) |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10038718 |
| E.1.2 | Term | Respiratory syncytial virus bronchiolitis |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061603 |
| E.1.2 | Term | Respiratory syncytial virus infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10035692 |
| E.1.2 | Term | Pneumonia due to respiratory syncytial virus |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10052200 |
| E.1.2 | Term | Respiratory syncytial virus infection NOS |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10066741 |
| E.1.2 | Term | Respiratory syncytial virus infection recurrent |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10067384 |
| E.1.2 | Term | Respiratory syncytial virus pneumonitis |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10069811 |
| E.1.2 | Term | Respiratory syncytial virus bronchitis |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To evaluate the safety and reactogenicity of 2 doses of the inves-tigational RSV vaccine administered IM according to a 0, 2 month schedule, up to one month after the last dose (Day 91, Visit 6). |
|
| E.2.2 | Secondary objectives of the trial |
For Part A and Part B:
• To characterize the humoral immune responses (including dose-response) in relation to the investigational RSV vaccine formulations administered IM according to a 0, 2 month schedule, up to one month after the last dose (Day 91, Visit 6).
• To characterize the cell-mediated immune responses in relation to the investigational RSV vaccine formulations administered IM according to a 0, 2 month schedule, up to one month after the last dose (Day 91, Visit 6).
For Part B:
• To evaluate the safety and reactogenicity of 2 doses of the investigational RSV vaccines administered IM according to a 0, 2 month schedule, up to the end of follow-up (Month 14, Visit 8).
• To evaluate the occurrence of RSV-associated respiratory tract infections (RTI) during the RSV season in nasal/throat swab samples collected during the assessment visit for potential RSV-RTI. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
For all subjects:
• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing any study specific procedure.
For Part A:
• A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
For Part B:
• A male or female between, and including, 60 and 80 years of age at the time of the first vaccination.
• Subjects with residence status allowing free mixing with general community or in an assisted-living facility that pro-vides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. |
|
| E.4 | Principal exclusion criteria |
For all subjects:
• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make IM injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (>= 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last 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 30 days after each study vaccination.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, 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. Patients with chronic stable conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
• Any other condition (e.g. chronic obstructive pulmonary disease or severe respiratory condition) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by the investigator based on medical history, physical examination or laboratory screening tests.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
• Previous vaccination with an RSV vaccine.
• Lymphoproliferative disorder and malignancy within 5 years.
• Body mass index > 40 kg/m².
• Planned move to a location that will prohibit participating in the trial until study end.
• At screening: Hematology parameters (complete blood cell count [red blood cells, white blood cells], white blood cells differential count [lymphocytes, neutrophils and eosinophils], platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood urea nitrogen or liver enzymes [alanine aminotransferase or aspartate aminotransferase]) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
For Part A:
• Pregnant or lactating female.
• Female subjects of childbearing potential, except if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
For Part B:
• Known previous administration of a vaccine containing MPL, QS-21 and/or MF59 (e.g. GSK Biologicals’ vaccine against human papillomavirus infection marketed as Cervarix, GSK Biologicals’ Herpes Zoster vaccine marketed as Shingrix, an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su], or MF59 adjuvanted influenza vaccines [e.g. Fluad]).
• Planned administration of GSK Biologicals’ Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su] within 180 days after the second dose of the study vaccine.
• Bedridden subjects. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
A. Number of subjects with any solicited local symptoms
B. Number of subjects with any general symptom
C. Number of subjects with any unsolicited adverse events (AEs)
D. Number of subjects presenting haematological and biochemical laboratory abnormalities
E. Number of subjects with Grade 3 non-serious AEs (solicited and unsolicited)
F. Number of subjects with serious adverse events (SAEs)
G. Number of subjects reporting any potential immune-mediated disease (pIMD) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) after each vaccination (for A and B)
During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after each vaccination (for C and E)
On the day of vaccination (Day 1 – pre-vaccination), at 7 days after the first vaccine dose (Day 8), on the day of second vaccination (Day 61 – post dose 1) and at 7 days after the second vaccine dose (Day 68) (for D)
From first vaccination (Day 1) up to 30 days post second vaccination (Day 91) (for F and G) |
|
| E.5.2 | Secondary end point(s) |
A. Neutralizing antibody titers against RSV serotype A
B. Anti-RSVPreF3-specific antibody concentrations
C. Frequency of RSVPreF3-specific cluster of differentiation 4+ (CD4+) T-cells expressing at least two markers
D. Number of subjects with any respiratory tract infection associated with RSV infection (RSV-RTI)
E. Number of subjects with serious adverse events (SAEs)
F. Number of subjects reporting any potential immune-mediated disease (pIMD) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61 – pre-Dose 2) and 30 days post-Dose 2 (Day 91) (for A, B and C)
From Dose 1 administration (Day 1) up to study conclusion (Month 14), during the RSV season only (for D)
From first vaccination (Day 1) up to study conclusion (Month 14) (for E and F) |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| E.7.1.1 | First administration to humans | Yes |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 14 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Last testing results released of samples collected up to Visit 8 in Part B (Month 14) (for assays related to primary and secondary endpoints only. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
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