A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults

NCT02723773 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2011902015-001778-17
• Study Type: interventional
• Target: 7,539
• Locations: 17 countries
• Sites: 159

Brief Summary

The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses in two subgroups of older adults.

Conditions

Herpes Zoster; Herpes Zoster Vaccine

Keywords

Efficacy; Immunogenicity; Safety; Adults; Herpes zoster

Outcome Measures

Primary Outcomes (1)

• Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall

  A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) and/or by HZ Ascertainment Committee (HZAC) determination, as per the algorithm pre-specified in the protocol. As pre-specified in the protocol: * due to the high VE observed in ZOSTER-006/022 studies, recipients of placebo in both studies were offered cross-vaccination with HZ/su. Since there was no placebo group in this study, historic controls were used for VE assessment. Incidence rates estimations on Historical Control group were done by utilizing Poisson regression model using placebo data from ZOSTER-006/022 studies to obtain the coefficients by age ranges. * the participants in Control group were a subset of LTFU group that were randomized to serve as control for those who were vaccinated in this study, otherwise they were treated similarly as LTFU group, hence LTFU and Control groups were combined.

  During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

Secondary Outcomes (25)

• Number of Participants Having at Least One Confirmed HZ Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, by Age Ranges

  During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

• Number of Participants Having at Least One Confirmed HZ Case From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges

  From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years

• Number of Participants Having at Least One Confirmed HZ Case Over the Follow-up Years From One Month Post-Dose 2 in ZOSTER-006/022 Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges

  Over the follow-up years (Year 1, Year 2, Year 3, Year 4, Year 6, Year 7, Year 8, Year 9, Year 10 and Year 11) from one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72)

• Number of Participants Having at Least One Post-herpetic Neuralgia (PHN) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges

  During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72)

• Number of Participants Having at Least One PHN Case From One Month Post-Dose 2 in ZOSTER-006/022 Primary Studies Until the End of ZOSTER-049:EXT 006-022 Study, Overall and by Age Ranges

  From one month post-Dose 2 (Month 3) in ZOSTER-006/022 primary studies until the end of ZOSTER-049:EXT 006-022 study (Month 72), a period of approximately 12 years

Study Arms (4)

LTFU Group

NO INTERVENTION

Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety.

1-Additional Dose Group

EXPERIMENTAL

Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study.

Biological: Herpes Zoster Vaccine GSK1437173A

Revaccination Group

EXPERIMENTAL

Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study.

Biological: Herpes Zoster Vaccine GSK1437173A

Control Group

NO INTERVENTION

Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group).

Interventions

Herpes Zoster Vaccine GSK1437173A BIOLOGICAL

Intramuscular injection

1-Additional Dose Group; Revaccination Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, availability for follow-up contacts).
• Written informed consent obtained from the subject prior to performance of any study specific procedure.
• Subject who participated in ZOSTER-006 or ZOSTER-022 studies and received at least one dose of HZ/su vaccine.
• Female subjects of non-childbearing potential may be enrolled in this study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in this study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (pharmaceutical product or device) at the time of enrolment or planned use during the study period.
• Previous vaccination against Varicella Zoster Virus (VZV) or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than the HZ/su vaccine administered in studies ZOSTER-006/022).
• Chronic administration (defined as ≥ 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period. For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent. A prednisone dose of \< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
• Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab) within 6 months prior to Visit Month 0 of study ZOSTER-049 or expected administration at any time during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
• Administration of immunoglobulins and/or any blood products within 3 months prior to Visit Month 0 of study ZOSTER-049 or planned administration during the study period.
• Prolonged use (\> 14 consecutive days) of oral and/or parenteral antiviral agents that are active against VZV (acyclovir, valacyclovir, famciclovir, etc. ) and planned to be used during the study period for an indication other than to treat suspected or confirmed HZ or an HZ-related complication (topical use of these antiviral agents is allowed).
• Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study.
• Subjects who experienced an SAE from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049 that was considered related to study vaccine by either the investigator or the sponsor.
• Subjects with a new onset of a pIMD or exacerbation of a pIMD from first vaccination in the previous ZOSTER-006/022 studies to enrolment in study ZOSTER-049.
• Use of any investigational or non-registered product (pharmaceutical product or device) within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Administration or planned administration of any other immunizations within 30 days before the first study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex-gloves, syringes, etc.). Please note, the vaccine and vials in this study do not contain latex.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (161)

GSK Investigational Site

Phoenix, Arizona, 29651, United States

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GSK Investigational Site

Phoenix, Arizona, 84123, United States

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GSK Investigational Site

Phoenix, Arizona, 85018, United States

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GSK Investigational Site

Phoenix, Arizona, 85020, United States

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GSK Investigational Site

Phoenix, Arizona, 85306, United States

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GSK Investigational Site

Spring Valley, California, 91978, United States

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GSK Investigational Site

Hallandale, Florida, 85213, United States

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Boise, Idaho, 83712, United States

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Wichita, Kansas, 67207, United States

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Columbia, Maryland, 21045, United States

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Elkridge, Maryland, 21075, United States

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GSK Investigational Site

Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28209, United States

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Hickory, North Carolina, 28601, United States

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Salisbury, North Carolina, 28144, United States

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Wilmington, North Carolina, 28412, United States

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Winston-Salem, North Carolina, 27103, United States

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Cleveland, Ohio, 44122, United States

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Wadsworth, Ohio, 44281, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Uniontown, Pennsylvania, 15401, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Bristol, Tennessee, 37620, United States

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San Antonio, Texas, 78229, United States

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Newport News, Virginia, 23606, United States

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Westmead, New South Wales, 2145, Australia

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Wollongong, New South Wales, 2522, Australia

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Geelong, Victoria, 3220, Australia

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Belo Horizonte, 30150-320, Brazil

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Curitiba, 80069-900, Brazil

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CuritibaPR, 80240-000, Brazil

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GSK Investigational Site

São Paulo, 04266-010, Brazil

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GSK Investigational Site

São Paulo, 04312903, Brazil

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Vancouver, British Columbia, V5Z 1M9, Canada

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Victoria, British Columbia, V8V 3M9, Canada

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Halifax, Nova Scotia, B3K 6R8, Canada

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Truro, Nova Scotia, B2N 1L2, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Woodstock, Ontario, N4V 0E1, Canada

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Gatineau, Quebec, J8Y1W2, Canada

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Montreal, Quebec, J7J 2K8, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Québec, Quebec, G1E 7G9, Canada

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Québec, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1J 2G2, Canada

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Brno, 612 00, Czechia

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České Budějovice, 370 05, Czechia

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GSK Investigational Site

Hradec Králové, 500 05, Czechia

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Tallinn, 13619, Estonia

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Tartu, 50106, Estonia

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GSK Investigational Site

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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Pori, 28100, 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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GSK Investigational Site

Angers, 49000, France

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Angers, 49100, France

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GSK Investigational Site

Château-Gontier, 53200, France

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Clermont-Ferrand, 63003, France

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Laval, 53000, France

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Montrevault, 49110, France

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Muret, 31600, France

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Mûrs-Erigné, 49610, France

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Nantes, 44300, France

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GSK Investigational Site

Rosiers-d'Égletons, 19300, France

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Segré, 49500, France

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GSK Investigational Site

Tours, 37100, France

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GSK Investigational Site

Berlin, 10629, Germany

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Berlin, 10787, 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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Dresden, 01097, Germany

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Essen, 45355, Germany

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Essen, 45359, Germany

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Flörsheim, 65439, Germany

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Freiberg, 09599, Germany

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Goch, 47574, Germany

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Güglingen, 74363, Germany

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Hamburg, 20251, Germany

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Hamburg, 22143, Germany

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Hamburg, 22415, Germany

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Köthen, 06366, Germany

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Künzing, 94550, Germany

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Leipzig, 04315, Germany

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Lübeck, 23554, Germany

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Magdeburg, 39112, Germany

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Mainz, 55116, Germany

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Mannheim, 68161, Germany

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München, 80339, Germany

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Rednitzhembach, 91126, Germany

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Rhaunen, 55624, Germany

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Tübingen, 72074, Germany

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Wallerfing, 94574, Germany

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Wangen, 88239, Germany

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Weinheim, 69469, Germany

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Witten, 58455, Germany

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Würzburg, 97070, Germany

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Kwun Tong Kowloon, Hong Kong

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GSK Investigational Site

Shatin, 000000, Hong Kong

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Chieti, 66013, Italy

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Genova, 16132, Italy

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Monza MB, 20900, Italy

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Roma, 00163, Italy

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Sassari, 07100, Italy

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GSK Investigational Site

Fukuoka, 810-0021, Japan

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Fukuoka, 812-0025, Japan

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GSK Investigational Site

Fukuoka, 813-8588, Japan

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Fukuoka, 816-0864, Japan

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Kanagawa, 224-8503, Japan

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Kanagawa, 247-8533, Japan

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Tokyo, 142-0054, Japan

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Tokyo, 142-8666, Japan

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Tokyo, 154-0024, Japan

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GSK Investigational Site

Durango, 34000, Mexico

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GSK Investigational Site

Zapopan Jalisco, 45190, Mexico

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GSK Investigational Site

Ansan, 425-707, South Korea

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GSK Investigational Site

Bucheon-si Kyunggi-do 14584, 420-767, South Korea

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GSK Investigational Site

Incheon, 400-711, South Korea

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Kangwon-do, 220-701, South Korea

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Seoul, 150-950, South Korea

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GSK Investigational Site

Seoul, 152-703, South Korea

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GSK Investigational Site

Alcover Tarragona, 43460, Spain

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GSK Investigational Site

Barcelona, 08025, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 08430, Spain

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GSK Investigational Site

Barcelona, 08540, Spain

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GSK Investigational Site

Barcelona, 28500, Spain

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GSK Investigational Site

Hostalets de Balenya Ba, 08550, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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Madrid, 28222, Spain

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GSK Investigational Site

Peralada Girona, 17491, Spain

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GSK Investigational Site

Valencia, 46020, Spain

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GSK Investigational Site

Borås, SE-506 30, Sweden

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GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

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Gothenburg, SE-413 45, Sweden

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GSK Investigational Site

Jönköping, SE-551 85, Sweden

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GSK Investigational Site

Karlskrona, SE-371 79, Sweden

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GSK Investigational Site

Linköping, SE-58758, Sweden

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Malmo, SE-211 52, Sweden

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Örebro, SE-703 62, Sweden

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Stockholm, 11446, Sweden

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GSK Investigational Site

Uppsala, SE-751 85, Sweden

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GSK Investigational Site

Vällingby, SE-194 61, Sweden

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GSK Investigational Site

Taichung, 40447, Taiwan

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GSK Investigational Site

Taipei, 10002, Taiwan

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GSK Investigational Site

Taipei, 112, Taiwan

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GSK Investigational Site

Tau-Yuan, 333, Taiwan

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GSK Investigational Site

Atherstone Warwickshire, CV9 1EU, United Kingdom

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GSK Investigational Site

Belfast, BT7 2EB, United Kingdom

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GSK Investigational Site

Bradford on Avon Wiltsh, BA15 1DQ, United Kingdom

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GSK Investigational Site

Broughshane, BT42 4JP, United Kingdom

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GSK Investigational Site

Chorley, PR7 7NA, United Kingdom

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GSK Investigational Site

Liverpool, L22 0LG, United Kingdom

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Related Publications (3)

• Strezova A, Diez Domingo J, Cunningham AL, Eto T, Andrews C, Arns C, Choo EJ, Hui DSC, Icardi G, McNeil SA, Poder A, Kosina P, Rombo L, Schwarz TF, Tinoco JC, Yu CJ, Wang J, Soni J, Tsang M, Leon R, Mwakingwe-Omari A; Zoster-049 Study Group. Final analysis of the ZOE-LTFU trial to 11 years post-vaccination: efficacy of the adjuvanted recombinant zoster vaccine against herpes zoster and related complications. EClinicalMedicine. 2025 May 9;83:103241. doi: 10.1016/j.eclinm.2025.103241. eCollection 2025 May.

  PMID: 40630610 BACKGROUND

• Giannelos N, Curran D, Matthews S, Carrico J, Cunningham AL. The Potential Impact of Increased Recombinant Zoster Vaccine Uptake in Older Adults Worldwide. Infect Dis Ther. 2025 Jun;14(6):1327-1341. doi: 10.1007/s40121-025-01161-y. Epub 2025 May 21.

  PMID: 40399558 DERIVED

• Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, Beytout J, Caso C, Cheng HS, Cheong HJ, Choo EJ, Curiac D, Di Paolo E, Dionne M, Eckermann T, Esen M, Ferguson M, Ghesquiere W, Hwang SJ, Avelino-Silva TJ, Kosina P, Liu CS, Markkula J, Moeckesch B, Murta de Oliveira C, Park DW, Pauksens K, Pirrotta P, Plassmann G, Pretswell C, Rombo L, Salaun B, Sanmartin Berglund J, Schenkenberger I, Schwarz T, Shi M, Ukkonen B, Zahaf T, Zerbini C, Schuind A, Cunningham AL; Zoster-049 Study Group. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022 Apr 28;74(8):1459-1467. doi: 10.1093/cid/ciab629.

  PMID: 34283213 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 30, 2016
• Study Start: April 16, 2016
• Primary Completion: June 28, 2023
• Study Completion: January 30, 2024
• Last Updated: December 12, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-11

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 asset(s) with development terminated 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 (3); GB (6); KR (6); DE (31); JP (9); CZ (3); IT (5); US (25); ME (2); BR (5); SE (11); CA (13); HK (2); FR (12); FI (10); TW (4); ES (12)