Efficacy study of GSK's investigational respiratory syncytial virus (RSV) vaccine in adults aged 60 years and above

JRCT ID: jRCT2031210109

Registered date:24/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: RSV infection
• Date of first enrollment: 18/06/2021
• Target sample size: 25000
• Countries of recruitment: Finland,Japan,Germany,Japan,Italy,Japan,Spain,Japan,Belgium,Japan,Estonia,Japan,Poland,Japan,Canada,Japan,Brazil,Japan,Republic of Korea,Japan,United Kingdom,Japan,United States,Japan,Australia,Japan,Mexico,Japan,Russian Federation,Japan,South Africa,Japan
• Study type: Interventional
• Intervention(s): The RSVPreF3 OA vaccine/Placebo administered intramuscularly into the deltoid of the nondominant arm at Visit 1, Visit 3 and Visit 5.

Outcome(s)

• Primary Outcome: First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD. The case definition for RSV-confirmed LRTD is as follows: Presence of lower respiratory symptoms/ signs for at least 24 hours and at least one RSV-positive swab detected by RT-PCR.

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- A male or female >-60 YOA at the time of the first vaccination, who live in the general community (CD participants) or in a LTCF (LTCF participants).
- 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 and questionnaires, attend regular phone calls/study site visits, perform self-swabbing, ability to access and utilize a phone or other electronic communications).
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

Exclude criteria

Medical conditions
-Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g. current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g. medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), 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 (e.g. completion of the diary cards and questionnaires, attend regular phone calls/study site visits, perform self-swabbing).
-Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g. life-threatening disease likely to limit survival to less than 3 years).
-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 (Day-29 to Day1), 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 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 the 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 (e.g. infliximab).
-Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the 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 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.
-Participation of any study personnel or their immediate dependants, family, or household members.
-Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.
(RSV seasons are from October to April in NH and from March to September in SH.)

Related Information

• Primary Sponsor: Okawa Yasutoshi