An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Description

The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Conditions

Respiratory Syncytial Virus Infections

Study Overview

Study Details

Study overview

The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

A Phase 3b, Randomized, Open Label, Multicountry, Multi-center, Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OA=ADJ-006 Study

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Condition
Respiratory Syncytial Virus Infections
Intervention / Treatment

-

Contacts and Locations

Birmingham

GSK Investigational Site, Birmingham, Alabama, United States, 35205

Birmingham

GSK Investigational Site, Birmingham, Alabama, United States, 35211

Huntsville

GSK Investigational Site, Huntsville, Alabama, United States, 35802

Phoenix

GSK Investigational Site, Phoenix, Arizona, United States, 85306

Tucson

GSK Investigational Site, Tucson, Arizona, United States, 85741

Cerritos

GSK Investigational Site, Cerritos, California, United States, 90703

Coral Gables

GSK Investigational Site, Coral Gables, Florida, United States, 33134

Fort Myers

GSK Investigational Site, Fort Myers, Florida, United States, 33912

Jacksonville

GSK Investigational Site, Jacksonville, Florida, United States, 32205

Lake City

GSK Investigational Site, Lake City, Florida, United States, 32055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group).
  • * 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, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications).
  • * 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 study entry. 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.
  • * 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.
  • * Hypersensitivity to latex.
  • * Serious or unstable chronic illness.
  • * Recurrent or un-controlled neurological disorders or seizures.
  • * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  • * Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • * Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures.
  • * Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
  • * Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

GlaxoSmithKline,

Study Record Dates

2026-09-30