Respiratory Syncytial Virus Infection MedDRA version: 21.1 Level: PT Classification code 10035732 Term: Pneumonia respiratory syncytial viral System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10069811 Term: Respiratory syncytial virus bronchitis System Organ Class: 1002
Conditions
Interventions
Product Name: High dose RSVPreF3/adjuvanted
Pharmaceutical Form: Powder and suspension for suspension for injection
INN or Proposed INN: N/A
Other descriptive name: Respiratory syncytial virus, glycop
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •A male or female = 60 YOA at the time of the first vaccination, who live in the general community (community dwelling participants) or in a long-term care facility (LTCF) (LTCF participants). •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries and/or questionnaires or make decisions on behalf of the participant •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. 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) yes F.1.2.1 Number of subjects for this age range 7500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17500
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 vaccine. •Hypersensitivity to latex. •Serious or unstable chronic illness. •Any history of dementia or any medical condition that moderately or severely impairs cognition. Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant. •Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active 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 vaccine during the period beginning 30 days before the first dose of study vaccine administration, 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 each dose and ending 30 days after each 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 14 days after each study vaccination. •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 first 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 first study vaccine administration 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 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 period that will prohibit participating in the trial until study end. This includes: -Planned move during the study period to another LTCF that will prohibit participation in the trial until study end. -Planned move from the community to a LTCF that will prohibit participation in the trial until study end. •Participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Demonstrate the efficacy of a single dose of the RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD during the first season in adults =60 YOA.;Secondary Objective: • Demonstrate efficacy of RSVPreF3 OA vaccine following a single and annual revaccination in preventing: - RSV-confirmed LRTD over several seasons & for each RSV subtype •Evaluate efficacy of RSVPreF3 OA vaccine after 1 dose and annual revaccination in preventing: -RSV-confirmed LRTD by age, season, year, baseline comorbidities & frailty satus, & for each RSV subtype, severity; -Hospitalization due to respiratory diseases; -Complications related to RSV-confirmed ARI & any ARI during RSV seasons and during the entire follow-up; -Any ARI & any LRTD •Evaluate efficacy of RSVPreF3 OA vaccine after 1 dose in preventing LRTD caused by other pathogens •Evolution of efficacy of single dose of study vaccine in preventing RSV-confirmed LRTD •Impact of the study vaccine after 1 dose and annual revaccination on LRT symptoms, ARI total symptoms, health utility score, physical functioning •Describe RSV-confirmed ARI & LRTD cases •Humoral immune response, reactogenicity & safety;Primary end point(s): Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD during the first season following a single dose of the RSVPreF3 OA vaccine in adults = 60 YOA ;Timepoint(s) of evaluation of this end point: From Day 15 post vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): *Number (No.) of participants with 1st episode of RT-PCR confirmed $No. of participants with ^RSV A &/or B 1)*^associated LRTD over several seasons** 2)*^associated LRTD over several seasons** and 1 annual revaccination before Season 2 3)*RSV subtype A&B LRTD over 3 seasons** 4)*RSV subtype A&B LRTD over 3 seasons*** 5)*LRTD caused by human metapneumovirus** 6)*^associated LRTD by age categories**** 7)*^associated LRTD by RSV season**** 8)*^associated LRTD by year**** 9)*^associated LRTD, by baseline comorbidities**** 10)*^associated LRTD by baseline frailty status**** 11)*^associated severe LRTD**** 12)*^associated ARI**** 13)$ 1st episode of any ARI or any LRTD**** 14)No. of hospitalizations due to respiratory diseases or due to a complication related to respiratory diseases, during the RSV seasons and during the entire follow-up**** 15)No. of hospitalizations due to RSV-confirmed respiratory diseases or due to complication related to RSV-confirmed respiratory diseases, during the RSV seasons and during the entire follow-up**** 16)No. of complications related to ARI & RSV-confirmed ARI during the RSV seasons and during the entire follow-up**** 17)Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest score for the participants with RT-PCR-confirmed ^associated ARI**** 18)Least Square Mean Flu-PRO total score for the participants with RT-PCR-confirmed ^associated ARI**** 19)EuroQol 5-dimension health questionnaire (EQ-5D) utility score for participants with RT-PCR-confirmed ^associated ARI**** 20)Short Form-12 (SF-12) physical functioning score for participants with RT-PCR confirmed RSV A &/or B-associated ARI**** 21)Duration of RT-PCR confirmed ^ARI & LRTD episodes 22)$ each reported symptom/sign of RT-PCR confirmed ^ARI episodes 23)$ each reported symptom/sign of RT-PCR confirmed ^LRTD episodes 24)$ RT-PCR confirmed ^ARI & LRTD episodes according to severity 25,26)RSVPreF3 binding immunoglobulin G(IgG) antibody concentrations 27,28)R | — |
Countries
Australia, Belgium, Canada, Estonia, Finland, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed