Immunogenicity, safety, reactogenicity and persistence of an investigational respiratory syncytial virus (RSV) vaccine in adults aged 60 years and above.

JRCT ID: jRCT2071200089

Registered date:25/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: RSV infection
• Date of first enrollment: 15/02/2021
• Target sample size: 1650
• Countries of recruitment: United States,Japan,Finland,Japan,Germany,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.

Outcome(s)

• Primary Outcome: RSV-A neutralizing antibodies are given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)

Key inclusion & exclusion criteria

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

Include criteria

- Male or female participants greater than or equal to 60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants).
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- 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. 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 medically stable.

Exclude 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.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Serious or unstable chronic illness.
- Recurrent or un-controlled 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.
- Any history of dementia or any medical condition that moderately or severely impairs cognition.
[Prior/Concomitant therapy]
- Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first 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 each dose and ending 30 days after each 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 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 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 first 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.
[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]
- 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 participation in the trial until the 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.

Related Information

• Primary Sponsor: Okawa Yasutoshi