> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-extension-and-crossover-vaccination-study-on-the-immune-ca7a804e-f4b9-4396-9e6f-5943cc7d9555 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) Participants 10,212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) Start date 2024-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) Number of sites 251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Acronym** RSV OA=ADJ=012 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Dates **Completion date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **First posted** 2024-08-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Registry last updated** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Primary completion date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Start date** 2024-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Size and sites **Actual participants** 10,212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Participants** 10,212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Number of sites** 251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Identifiers **Registry ID** NCT06534892 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **ClinicalTrials.gov ID** NCT06534892 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Outcomes ### Primary outcomes 1. RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV\_PreS4 group at Day 1 Timeframe: At Day 1 2. RSV-A neutralizing titers expressed as GMTs in RSV\_PreS4 group at Day 31 Timeframe: At Day 31 3. RSV-B neutralizing titers expressed as GMTs in RSV\_PreS4 group at Day 1 Timeframe: At Day 1 4. RSV-B neutralizing titers expressed as GMTs in RSV\_PreS4 group at Day 31 Timeframe: At Day 31 5. RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV\_PreS4 group Timeframe: From Day 1 to Day 31 6. RSV-B neutralizing titers expressed as MGI in RSV\_PreS4 group Timeframe: From Day 1 to Day 31 7. Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV\_PreS4 group at Day 1 Timeframe: At Day 1 8. Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV\_PreS4 group at Day 31 Timeframe: At Day 31 9. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV\_PreS4 group at Day 1 Timeframe: At Day 1 10. Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV\_PreS4 group at Day 31 Timeframe: At Day 31 11. Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV\_PreS4 group Timeframe: At Day 31 12. Percentage of participants with SRR for RSV-B neutralizing titers in RSV\_PreS4 group Timeframe: At Day 31 13. RSV-A neutralizing titers expressed as GMT in RSV\_PreS5 group at Day 1 Timeframe: At Day 1 14. RSV-A neutralizing titers expressed as GMT in RSV\_PreS5 group at Month 12 Timeframe: At Month 12 15. RSV-A neutralizing titers expressed as GMT in RSV\_PreS5 group at Month 13 Timeframe: At Month 13 16. RSV-A neutralizing titers expressed as GMT in RSV\_PreS5 group at Month 24 Timeframe: At Month 24 17. RSV-B neutralizing titers expressed as GMTs in RSV\_PreS5 group at Day 1 Timeframe: At Day 1 18. RSV-B neutralizing titers expressed as GMTs in RSV\_PreS5 group at Month 12 Timeframe: At Month 12 19. RSV-B neutralizing titers expressed as GMTs in RSV\_PreS5 group at Month 13 Timeframe: At Month 13 20. RSV-B neutralizing titers expressed as GMTs in RSV\_PreS5 group at Month 24 Timeframe: At Month 24 21. RSV-A neutralizing titers expressed as MGI in RSV\_PreS5 group from Month 12 to Month 13 Timeframe: From Month 12 to Month 13 22. RSV-A neutralizing titers expressed as MGI in RSV\_PreS5 group from Month 12 to Month 24 Timeframe: From Month 12 to Month 24 23. RSV-B neutralizing titers expressed as MGI in RSV\_PreS5 group from Month 12 to Month 13 Timeframe: From Month 12 to Month 13 24. RSV-B neutralizing titers expressed as MGI in RSV\_PreS5 group from Month 12 to Month 24 Timeframe: From Month 12 to Month 24 25. Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV\_PreS5 group at Day 1 Timeframe: At Day 1 And 9 more, listed on the interactive page. ### Secondary outcomes 1. RSV-A neutralizing titers expressed as GMTs in RSV\_1Dose group Timeframe: At Day 1, Month 12 and at Month 24 2. RSV-B neutralizing titers expressed as GMTs in RSV\_1Dose group Timeframe: At Day 1, Month 12 and at Month 24 3. Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV\_1Dose group Timeframe: At Day 1, Month 12 and at Month 24 4. Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV\_1Dose group Timeframe: At Day 1, Month 12 and at Month 24 5. Number of participants with unsolicited adverse events Timeframe: At Day 30 post vaccination 6. Number of participants with any serious adverse events (SAEs) Timeframe: From day of vaccination and up to 6 months post each vaccine administration 7. Number of participants with SAEs related to study intervention Timeframe: From Day 1 and up to end of study 8. Number of participants with any potential immune-mediated disease (pIMDs) Timeframe: From day of vaccination and up to 6 months post each vaccine administration 9. Number of participants with pIMDs related to study intervention Timeframe: From Day 1 and up to end of study 10. Number of participants with fatal SAEs Timeframe: From Day 1 and up to end of study Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Healthy volunteers** Yes ### Inclusion 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. ### Exclusion 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 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: • 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 Exclusion Criteria: - 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. - Participation of any study personnel or their immediate dependents, family, or household members. - Bedridden participants. Specific exclusion criteria for Crossover group: • Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines which can be administered up to 14 days before or from 14 days after study vaccination. Inactivated seasonal influenza vaccines can be co-administered or administered at any time. Specific exclusion criteria for RSV\_PreS4, RSV\_PreS5 and RSV\_1Dose groups: - Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines and inactivated seasonal influenza vaccines which can be administered up to 14 days before or from 14 days after study intervention administration. - 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 study visit or planned administration during the study period. - Chronic administration of immunosuppressants or other immunemodifying drugs during the period starting 90 days prior to the first study visit or planned administration during the study period. For corticosteroids, this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Sites - GSK Investigational SiteBirmingham, United States - GSK Investigational SiteBirmingham, United States - GSK Investigational SiteHuntsville, United States - GSK Investigational SitePhoenix, United States - GSK Investigational SiteTucson, United States - GSK Investigational SiteCerritos, United States - GSK Investigational SiteDoral, United States - GSK Investigational SiteFort Myers, United States - GSK Investigational SiteJacksonville, United States - GSK Investigational SiteLake City, United States - GSK Investigational SiteMelbourne, United States - GSK Investigational SiteMiami, United States - GSK Investigational SiteOrlando, United States - GSK Investigational SitePinellas Park, United States - GSK Investigational SiteThe Villages, United States - GSK Investigational SiteWest Palm Beach, United States - GSK Investigational SiteAtlanta, United States - GSK Investigational SiteSavannah, United States - GSK Investigational SiteChicago, United States - GSK Investigational SiteEvansville, United States - GSK Investigational SiteMishawaka, United States - GSK Investigational SiteEl Dorado, United States - GSK Investigational SiteNewton, United States - GSK Investigational SiteWichita, United States - GSK Investigational SiteWichita, United States And 226 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## References ### Other registry identifiers (2) - 2023 - 2023-509762-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06534892) ## Related records ### Drugs (1) - [Respiratory syncytial virus pre-fusion glycoprotein F](https://trialight.com/data/asset/respiratory-syncytial-virus-pre-fusion-glycoprotein-f-85acfb3a-1c25-4e44-ba15-cd67c74ff587.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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