Healthy volunteers (Active immunisation for the prevention of disease caused by RSV in adults aged 60 years or above)
Conditions
Interventions
Product Name: High dose RSVPreF3/Adjuvanted
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: na
Other descriptive name: GSKVx000000017064
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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. ;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);Secondary Objective: • 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.;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 addit | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 a) and interferon gamma (IFN ?), 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.;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) | — |
Countries
Belgium, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed