Respiratory syncytial virus infection
Conditions
Interventions
Product Name: High dose RSVPreF3/adjuvanted
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: NA
Current Sponsor code: GSKVx000000017064
Other descriptive na
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the electronic diary cards [eDiaries], return for follow-up visits, ability to access and utilize a phone or other electronic communications). • A male or female = 65 YOA at the time of the first study intervention administration. • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. • 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 study intervention administration. Participants 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1028
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 (no laboratory testing required). • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine. • Hypersensitivity to latex. • Guillain-Barré syndrome that occurred within 6 weeks of receipt of prior influenza vaccine. • Serious or unstable chronic illness. • Any history of dementia or any medical condition that moderately or severely impairs cognition. • Recurrent or uncontrolled 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. Prior/Concomitant therapy • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or planned use during the study period. • Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration. • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. In the case of COVID-19 vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided this COVID-19 vaccine use is in line with local governmental recommendations. • 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 administration of first dose of study interventions 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 study intervention 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 (drug or invasive medical device). 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 conduct that prohibits participation until study end. • Part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA investigational vaccine compared to the FLU vaccine administered alone. • To demonstrate the non-inferiority of the RSVPreF3 OA investigational vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA investigational vaccine administered alone. ;Primary end point(s): 1. Hemagglutination inhibition (HI) antibody titers for each of the FLU vaccine strains, expressed as group geometric mean titer (GMT) ratio 2. RSV-A neutralization antibody titers expressed as group GMT ratio ;Timepoint(s) of evaluation of this end point: 1. At 1 month after the FLU vaccine dose (Day 31 for both groups) 2. At 1 month after the RSVPreF3 OA investigational vaccine dose (Day 31 for the Co Ad Group and Day 61 for the Control Group) ;Secondary Objective: • To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA investigational vaccine compared to the FLU vaccine administered alone. • To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine when co-administered with the FLU vaccine or administered alone • To evaluate the humoral immune response to the FLU vaccine when co-administered with the RSVPreF3 OA investigational vaccine or administered alone. • To evaluate the safety and reactogenicity following administration of the RSVPreF3 OA investigational vaccine and the FLU vaccine, co-administered or administered alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. HI seroconversion rate (SCR) for each of the FLU vaccine strains 2. RSV-A neutralization antibody titers expressed as mean geometric increase (MGI) 3. RSV-B neutralization antibody titers expressed as group GMT ratio 4. RSV-B neutralization antibody titers expressed as MGI 5. HI antibody titers for each of the FLU vaccine strains, expressed as GMT 6. HI SCR for each of the FLU vaccine strains 7. HI seroprotection rate (SPR) for each of the FLU vaccine strains 8. HI antibody titers for each of the FLU vaccine strains, expressed as MGI 9. Percentage of participants reporting each solicited administration site event 10. Percentage of participants reporting each solicited systemic event 11. Percentage of participants reporting unsolicited adverse events (AEs) 12. Percentage of participants reporting SAEs 13. Percentage of participants reporting pIMDs;Timepoint(s) of evaluation of this end point: 1, 8. At 1 month after the FLU vaccine dose (Day 31 for both groups) 2, 3, 4. At 1 month after the RSVPreF3 OA investigational vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) 5, 7. At Day 1 and Day 31 6. From Day 1 to Day 31 9, 10. Within 7 days (the day of vaccination and 6 subsequent days) after vaccine administration 11. Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration 12, 13. From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group) | — |
Countries
Belgium, Finland, France, Spain, United Kingdom
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed