ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-01
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06534892

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * 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).
  3. * Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
  4. * 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.
  1. * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy based on medical history and physical examination.
  2. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
  3. * Hypersensitivity to latex.
  4. * Serious or unstable chronic illness.
  5. * Recurrent or un-controlled neurological disorders or seizures.
  6. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  7. * Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  8. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  9. * 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.
  10. * 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.
  11. * 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.

Contacts and Locations

Study Locations (Sites)

GSK Investigational Site
Birmingham, Alabama, 35205
United States
GSK Investigational Site
Birmingham, Alabama, 35211
United States
GSK Investigational Site
Huntsville, Alabama, 35802
United States
GSK Investigational Site
Phoenix, Arizona, 85020
United States
GSK Investigational Site
Tucson, Arizona, 85741
United States
GSK Investigational Site
Cerritos, California, 90703
United States
GSK Investigational Site
Doral, Florida, 33172
United States
GSK Investigational Site
Fort Myers, Florida, 33912
United States
GSK Investigational Site
Jacksonville, Florida, 32205
United States
GSK Investigational Site
Lake City, Florida, 32055
United States
GSK Investigational Site
Melbourne, Florida, 32934
United States
GSK Investigational Site
Miami, Florida, 33174
United States
GSK Investigational Site
Orlando, Florida, 32806
United States
GSK Investigational Site
Pinellas Park, Florida, 33781
United States
GSK Investigational Site
The Villages, Florida, 32162
United States
GSK Investigational Site
West Palm Beach, Florida, 33409
United States
GSK Investigational Site
Atlanta, Georgia, 30328
United States
GSK Investigational Site
Savannah, Georgia, 31406
United States
GSK Investigational Site
Chicago, Illinois, 60602
United States
GSK Investigational Site
Evansville, Indiana, 47714
United States
GSK Investigational Site
Mishawaka, Indiana, 46544
United States
GSK Investigational Site
El Dorado, Kansas, 67042
United States
GSK Investigational Site
Newton, Kansas, 67114
United States
GSK Investigational Site
Wichita, Kansas, 67205
United States
GSK Investigational Site
Wichita, Kansas, 67207
United States
GSK Investigational Site
Lexington, Kentucky, 40509
United States
GSK Investigational Site
Rockville, Maryland, 20854
United States
GSK Investigational Site
Richfield, Minnesota, 55423
United States
GSK Investigational Site
Kansas City, Missouri, 64114
United States
GSK Investigational Site
St Louis, Missouri, 63141
United States
GSK Investigational Site
Omaha, Nebraska, 68134
United States
GSK Investigational Site
Las Vegas, Nevada, 89113
United States
GSK Investigational Site
New York, New York, 10017
United States
GSK Investigational Site
Rochester, New York, 14609
United States
GSK Investigational Site
Hickory, North Carolina, 28601
United States
GSK Investigational Site
Mooresville, North Carolina, 28117
United States
GSK Investigational Site
Rocky Mount, North Carolina, 27804
United States
GSK Investigational Site
Salisbury, North Carolina, 28144
United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103
United States
GSK Investigational Site
Centerville, Ohio, 45459
United States
GSK Investigational Site
Cincinnati, Ohio, 45236
United States
GSK Investigational Site
Columbus, Ohio, 43212
United States
GSK Investigational Site
Erie, Pennsylvania, 16508
United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
United States
GSK Investigational Site
Anderson, South Carolina, 29621
United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29405
United States
GSK Investigational Site
Knoxville, Tennessee, 37938
United States
GSK Investigational Site
Memphis, Tennessee, 38119
United States
GSK Investigational Site
Dallas, Texas, 75234
United States
GSK Investigational Site
Fort Worth, Texas, 76104
United States
GSK Investigational Site
Houston, Texas, 77008
United States
GSK Investigational Site
Keller, Texas, 76248
United States
GSK Investigational Site
San Antonio, Texas, 78229
United States
GSK Investigational Site
Salt Lake City, Utah, 84106
United States
GSK Investigational Site
Norfolk, Virginia, 23502
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Respiratory syncytial virus (RSV)
  • Older adults
  • RSVPreF3 OA vaccine
  • Immunogenicity
  • Safety
  • RSV Season

Additional Relevant MeSH Terms

  • Respiratory Syncytial Virus Infections