A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-59
SponsorGlaxoSmithKline

About this trial

The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.

Eligibility criteria

Qualifiers

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 (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.

A male or female participant 18-59 YOA at the time of the study intervention administration.

A stable condition is defined as a disease not requiring significant change (based on the investigator's opinion) in therapy or worsening during the 3 months before enrollment.

Disqualifiers

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 study intervention

Unstable chronic illness.

Any history of dementia or any medical condition that moderately or severely impairs cognition.

Trial design

Treatments tested in this trial

  • RSVPreF3 OA vaccine
  • Placebo

Treatment groups

750 Participants
are divided into 2 treatment groups

Sponsors and collaborators