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

NCT06534892 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2220902023-509762-38-00
• Study Type: interventional
• Target: 10,212
• Locations: 16 countries
• Sites: 243

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (34)

• RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1

  At Day 1

• RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

  At Day 31

• RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1

  At Day 1

• RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

  At Day 31

• RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group

  From Day 1 to Day 31

• RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group

  From Day 1 to Day 31

• Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group at Day 1

  At Day 1

• Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_PreS4 group at Day 31

  At Day 31

• Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 1

  At Day 1

• Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 31

  At Day 31

• Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS4 group

  At Day 31

• Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS4 group

  At Day 31

• RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Day 1

  At Day 1

• RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 12

  At Month 12

• RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 13

  At Month 13

• RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 24

  At Month 24

• RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Day 1

  At Day 1

• RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 12

  At Month 12

• RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 13

  At Month 13

• RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 24

  At Month 24

• RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13

  From Month 12 to Month 13

• RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24

  From Month 12 to Month 24

• RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13

  From Month 12 to Month 13

• RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24

  From Month 12 to Month 24

• Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Day 1

  At Day 1

• Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 12

  At Month 12

• Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 13

  At Month 13

• Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 24

  At Month 24

• Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Day 1

  At Day 1

• Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 12

  At Month 12

• Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 13

  At Month 13

• Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 24

  At Month 24

• Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS5 group

  At Month 13

• Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS5 group

  At Month 13

Secondary Outcomes (10)

• RSV-A neutralizing titers expressed as GMTs in RSV_1Dose group

  At Day 1, Month 12 and at Month 24

• RSV-B neutralizing titers expressed as GMTs in RSV_1Dose group

  At Day 1, Month 12 and at Month 24

• Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_1Dose group

  At Day 1, Month 12 and at Month 24

• Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV_1Dose group

  At Day 1, Month 12 and at Month 24

• Number of participants with unsolicited adverse events

  At Day 30 post vaccination

Study Arms (4)

RSV_PreS4

EXPERIMENTAL

Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.

Biological: RSVPreF3 OA vaccine

RSV_PreS5

EXPERIMENTAL

Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.

Biological: RSVPreF3 OA vaccine

RSV_1Dose

NO INTERVENTION

Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine.

Crossover

EXPERIMENTAL

Participants in this group will receive a single dose of RSVPreF3 OA vaccine.

Biological: RSVPreF3 OA vaccine

Interventions

RSVPreF3 OA vaccine BIOLOGICAL

RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

Crossover; RSV_PreS4; RSV_PreS5

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.
• 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. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.
• Prior/Concurrent Clinical Study Experience:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (249)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35211, United States

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Huntsville, Alabama, 35802, United States

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Phoenix, Arizona, 85020, United States

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Tucson, Arizona, 85741, United States

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Cerritos, California, 90703, United States

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Doral, Florida, 33172, United States

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Fort Myers, Florida, 33912, United States

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Jacksonville, Florida, 32205, United States

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Lake City, Florida, 32055, United States

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Melbourne, Florida, 32934, United States

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Miami, Florida, 33174, United States

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Orlando, Florida, 32806, United States

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Pinellas Park, Florida, 33781, United States

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The Villages, Florida, 32162, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30328, United States

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Savannah, Georgia, 31406, United States

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Chicago, Illinois, 60602, United States

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Evansville, Indiana, 47714, United States

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Mishawaka, Indiana, 46544, United States

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El Dorado, Kansas, 67042, United States

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Newton, Kansas, 67114, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67226, United States

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Lexington, Kentucky, 40509, United States

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Rockville, Maryland, 20854, United States

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Richfield, Minnesota, 55423, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89113, United States

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New York, New York, 10017, United States

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Rochester, New York, 14609, United States

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Hickory, North Carolina, 28601, United States

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Mooresville, North Carolina, 28117, United States

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Rocky Mount, North Carolina, 27804, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Centerville, Ohio, 45459, United States

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Cincinnati, Ohio, 45236, United States

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Columbus, Ohio, 43212, United States

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Erie, Pennsylvania, 16508, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Anderson, South Carolina, 29621, United States

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Mt. Pleasant, South Carolina, 29405, United States

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Knoxville, Tennessee, 37938, United States

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Memphis, Tennessee, 38119, United States

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Dallas, Texas, 75234, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77008, United States

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Keller, Texas, 76248, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84106, United States

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Norfolk, Virginia, 23502, United States

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Botany, New South Wales, 2019, Australia

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Coffs Harbour, New South Wales, 2450, Australia

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Sydney, New South Wales, 2010, Australia

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Taringa, Queensland, 4068, Australia

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Tarragindi, Queensland, 4121, Australia

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Camberwell, Victoria, 3124, Australia

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Geelong, Victoria, 3220, Australia

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Spearwood, Western Australia, 6163, Australia

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Diepenbeek, 3590, Belgium

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Edegem, 2650, Belgium

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Erpent, 5101, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Ieper, 8900, Belgium

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Kluisbergen, 9690, Belgium

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Linkebeek, 3545, Belgium

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Linkebeek, 6534, Belgium

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Mechelen, 2800, Belgium

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Tremelo, 3120, Belgium

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Edmonton, Alberta, T5A 4L8, Canada

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New Westminster, British Columbia, V3L 3W4, Canada

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Surrey, British Columbia, V3S 2N6, Canada

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Vancouver, British Columbia, V6Z 2T1, Canada

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Victoria, British Columbia, V8V 3M9, Canada

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Victoria, British Columbia, V8V 4A1, Canada

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Halifax, Nova Scotia, B3J 3G9, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Greater Sudbury, Ontario, P3C 1X3, Canada

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London-Ontario, Ontario, N5W 6A2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Chicoutimi, Quebec, G7H 7Y8, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Pointe-Claire, Quebec, H9R4S3, Canada

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Québec, Quebec, G1W 4R4, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Sainte-Foy, Quebec, G1E 7G9, Canada

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Sherbrooke, Quebec, J1J 2G2, Canada

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Paide, 72713, Estonia

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Tallinn, 10117, Estonia

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Tallinn, 10128, Estonia

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Tallinn, 10617, Estonia

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Tallinn, 13619, Estonia

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Tartu, 51014, Estonia

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Espoo, 02230, Finland

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Helsinki, 00100, Finland

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Helsinki, 00930, Finland

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Jarvenpaa, 04400, Finland

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Kokkola, 67100, Finland

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Oulu, 90220, Finland

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Seinäjoki, 60100, Finland

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Tampere, 33100, Finland

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Turku, 20520, Finland

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Weinheim, Baden-Wurttemberg, 69469, Germany

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Munich, Bavaria, 80339, Germany

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Freiberg, Saxony, 09599, Germany

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Berlin, 10117, Germany

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Berlin, 12627, Germany

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Berlin, 13347, Germany

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Cologne, 51069, Germany

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Dachau, 85221, Germany

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Dippoldiswalde, 01744, Germany

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Dresden, 01279, Germany

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Essen, 45355, Germany

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Essen, 45359, Germany

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Frankfurt, 60313, Germany

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Freital, 01705, Germany

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Goch, 47574, Germany

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Hamburg, 20095, Germany

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Hanover, 30159, Germany

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Hochheim am Main, 65239, Germany

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Leipzig, 04103, Germany

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Mainz, 55116, Germany

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Schenefeld, 22869, Germany

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Wallerfing, 94574, Germany

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Wangen, 88239, Germany

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Witten, 58455, Germany

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Würzburg, 97070, Germany

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Alessandria, 15121, Italy

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Bari, 70124, Italy

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Belluno, 32100, Italy

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Ferrara, 44124, Italy

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Naples, 80131, Italy

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Negrar Verona, 37024, Italy

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Palermo, 90127, Italy

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Pessione - Chieri to, 10023, Italy

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Pisa, 56126, Italy

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Roma, 00128, Italy

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Siena, 53100, Italy

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Hiroshima, 732-0053, Japan

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Ibaraki, 306-0041, Japan

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Kumamoto, 860-0863, Japan

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Okinawa, 901-2393, Japan

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Saitama, 350-1122, Japan

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Shizuoka, 421-0193, Japan

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Tokyo, 121-0815, Japan

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Tokyo, 160-0017, Japan

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Tokyo, 165-0031, Japan

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Tokyo, 169-0072, Japan

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Yamagata, 990-0834, Japan

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Yamaguchi, 750-0061, Japan

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Chihuahua City, 31203, Mexico

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León, 37530, Mexico

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Mexico City, 06760, Mexico

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Mérida, 97070, Mexico

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Monterrey, 64460, Mexico

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Oaxaca City, 68000, Mexico

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Querétaro, 76070, Mexico

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RM Pharmamexico CITY, 03100, Mexico

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San Luis Potosí City, 78209, Mexico

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Grafton Auckland, 1010, New Zealand

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Hawke's Bay, 4122, New Zealand

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Kapiti, 5032, New Zealand

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Palmerston North, 4414, New Zealand

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Tauranga, 3110, New Zealand

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Wellington, 6021, New Zealand

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Częstochowa, 42-202, Poland

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Elblag, 82-300, Poland

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Gdansk, 80-382, Poland

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Gdynia, 81-537, Poland

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Katowice, 40-040, Poland

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Katowice, 40-282, Poland

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Katowice, 40-648, Poland

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Krakow, 31-501, Poland

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Lodz, 90-127, Poland

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Lodz, 91-363, Poland

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Poznan, 60-702, Poland

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Warsaw, 02-672, Poland

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Warsaw, 03-291, Poland

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Wroclaw, 50-088, Poland

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Wroclaw, 53-671, Poland

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Gatchina, Leningradskaya Oblast', 188300, Russia

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Barnaul, 656043, Russia

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Kemerovo, 650066, Russia

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Moscow, 115478, Russia

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Saint Petersburg, 196158, Russia

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Saint Petersburg, 197022, Russia

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StPetersburg, 191119, Russia

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StPetersburg, 196143, Russia

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Yekaterinburg, 620137, Russia

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Reiger Park, Gauteng, 1459, South Africa

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Bloemfontein, 9300, South Africa

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Cape Town, 7700, South Africa

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Johannesburg, 1818, South Africa

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Johannesburg, 2113, South Africa

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Middelburg, 1050, South Africa

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Moloto South, 1022, South Africa

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Tembisa, 1632, South Africa

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GSK Investigational Site

Ansan, 15355, South Korea

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Bucheon-si Kyunggi-do 14584, 14584, South Korea

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Daegu, 41944, South Korea

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Incheon, 400-711, South Korea

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Jeonju, 54907, South Korea

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Kangwon-do, 26426, South Korea

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Seoul, 06351, South Korea

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Seoul, 07441, South Korea

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Seoul, 08308, South Korea

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Seoul, 135-720, South Korea

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Seoul, 137-701, South Korea

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Suwon Gyeonggi-do, 442-723, South Korea

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GSK Investigational Site

Alcorcón, 28922, Spain

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Barcelona, 08023, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Barcelona, 08430, Spain

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GSK Investigational Site

Barcelona, 08500, Spain

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GSK Investigational Site

Barcelona, 08540, Spain

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GSK Investigational Site

Barcelona, 08907, Spain

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GSK Investigational Site

Barcelona, 8025, Spain

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GSK Investigational Site

Madrid, 28006, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Madrid, 28222, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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Valencia, 46020, Spain

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GSK Investigational Site

Bebington, CH63 9JP, United Kingdom

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Belfast, BT2 8BG, United Kingdom

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Birmingham, B15 2SQ, United Kingdom

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Bradford on Avon Wiltsh, BA15 1DQ, United Kingdom

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Cardiff, CF15 9SS, United Kingdom

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Corby, NN17 2UR, United Kingdom

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Eynsham, OX29 4QB, United Kingdom

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Glasgow, ML4 3NJ, United Kingdom

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Hexham, NE46 1QJ, United Kingdom

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Lancashire, PR7 7NA, United Kingdom

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Liverpool, L22 0LG, United Kingdom

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Manchester, M15 6SE, United Kingdom

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Orpington, BR5 3QG, United Kingdom

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Oxford, OX4 1XB, United Kingdom

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Peterborough, PE8 6PL, United Kingdom

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Royal Leamington Spa, CV32 4RA, United Kingdom

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Thetford, IP24 1JD, United Kingdom

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Witney, OX28 6JS, United Kingdom

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MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an extension and crossover study.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

AU (8); BE (11); GB (18); RU (9); US (55); JP (12); NZ (6); ES (15); KR (12); ME (9); ZA (8); PL (15); FI (9); DE (25); CA (20); IT (11)