E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Active immunisation for the prevention of disease caused by RSV in adults aged 60 years or above) |
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E.1.1.1 | Medical condition in easily understood language |
RSV is a common virus that leads to mild, cold-like symptoms. RSV can cause severe infection in older adults, infants and adults with heart and lung disease, or anyone with a very weak immune system. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 following intramuscular (IM) administration of RSVPreF3 OA investigational vaccine up to 1 month post-Dose 3, for all participants.
• To evaluate the humoral immune response following IM administration of RSVPreF3 OA investigational vaccine up to 1 month post-Dose 3, for participants vaccinated with 2 doses of RSVPreF3 OA investigational vaccine in the parent study.
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E.2.2 | Secondary objectives of the trial |
• To evaluate the humoral and cell-mediated immune (CMI) response following IM administration of RSVPreF3 OA investigational vaccine up to 1 month post-Dose 3, for participants vaccinated with 2 doses of RSVPreF3 OA investigational vaccine in the parent study.
• To evaluate the safety and reactogenicity following IM administration of RSVPreF3 OA investigational vaccine up to the study end, for all participants. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female participants, who received 2 doses of RSVPreF3 OA investigational vaccine and formulations with matched adjuvant in part B of the parent study RSV OA=ADJ-002: recombinant RSVPreF3 antigen doses of low, medium and high strengths with adjuvant.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit, be available for contact)
• Written informed consent obtained from the participant prior to performance of any study specific procedure. |
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E.4 | Principal exclusion criteria |
Medical conditions
• Significant underlying illness or administered therapy that in the opinion of the investigator would be expected to prevent participation in the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on information on concomitant medication/vaccination collected prior to the study start and physical examination.
• Serious or unstable chronic illness that developed during or after the parent study. 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 clinically stable.
• Recurrent or un-controlled neurological disorders or seizures that developed during or after the parent study. 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 developed during or after the parent study, that in the opinion of the investigator would be expected to prevent completion of the study.
• Lymphoproliferative disorder and malignancy developed during or after the parent study.
• Any medical condition that developed during or after the parent study, that in the judgment of the investigator would make intramuscular injection unsafe.
• Previous vaccination with RSV vaccine, other than the one in the parent study.
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 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 and ending 30 days after the 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 30 days after the study vaccination.
• 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 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 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.
• Confirmed use or anticipated use of immunosuppressive/cytotoxic therapy.
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
• Bedridden participants.
• Planned move to a location that will prohibit participating in the trial.
• History of chronic alcohol consumption and/or drug abuse that developed during or after the parent study as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of participants with solicited adverse events (AEs)
Assessed solicited administration site events includes pain, redness and swelling, at the injection site. Any pain = any pain regardless of intensity grade. Any redness/swelling = redness/swelling higher than (>) 20 millimeters (mm), regardless of intensity grade.
Assessed solicited systemic events includes Fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)]
All solicited events (administration site and systemic events) will be considered related to the medicinal product.
2. Number of participants with unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
3. Number of participants with serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
4. Number of participants with potential immune-mediated diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
5. Neutralizing antibody titers against RSV serotype A
Neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).
6. Neutralizing antibody titers against RSV serotype B
Neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to 4 days post-Dose 3 (Day 4)
2. Up to 30 days post-Dose 3 (Day 31)
3. Up to 30 days post-Dose 3 (Day 31)
4. Up to 30 days post-Dose 3 (Day 31)
5. At 1 month post-Dose 3 (Day 31)
6. At 1 month post-Dose 3 (Day 31) |
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E.5.2 | Secondary end point(s) |
1. RSVPreF3-specific antibody concentrations
Serological assays for the determination of antibodies against RSV PreF3 are performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC is expressed in ELISA Laboratory Units per milliliter (EL.U/mL).
2. Frequency of RSVPreF3-specific cluster of differentiation 4+ (CD4+) T-cells identified as expressing at least two markers
Among markers expressed are interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
3. Number of participants with SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
4. Number of participants with pIMDs
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. At 1 month post-Dose 3 (Day 31)
2. At 1 month post-Dose 3 (Day 31)
3. From Day 1 up to study end (Month 6)
4. From Day 1 up to study end (Month 6) |
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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 | No |
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 |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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
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Last subject last visit (LSLV) (i.e. contact at Month 6) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 29 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 29 |