Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
NCT ID: NCT04502693
Last Updated: 2024-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3657 participants
INTERVENTIONAL
2020-08-14
2022-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MenB_0_2_6 Group
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
rMenB+OMV NZ vaccine
rMenB+OMV NZ vaccine was administered intramuscularly.
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
MenACWY vaccine was administered intramuscularly.
MenB_0_6 Group
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.
rMenB+OMV NZ vaccine
rMenB+OMV NZ vaccine was administered intramuscularly.
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
MenACWY vaccine was administered intramuscularly.
Placebo
Placebo was administered intramuscularly.
ABCWY-1 Group
Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Placebo
Placebo was administered intramuscularly.
MenABCWY-1
Lot 1 of the MenABCWY vaccine was administered intramuscularly.
ABCWY-2 Group
Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Placebo
Placebo was administered intramuscularly.
MenABCWY-2
Lot 2 of the MenABCWY vaccine was administered intramuscularly.
ABCWY-3 Group
Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Placebo
Placebo was administered intramuscularly.
MenABCWY-3
Lot 3 of the MenABCWY vaccine was administered intramuscularly.
ACWY Group
Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
rMenB+OMV NZ vaccine
rMenB+OMV NZ vaccine was administered intramuscularly.
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
MenACWY vaccine was administered intramuscularly.
Placebo
Placebo was administered intramuscularly.
ABCWY_Pooled
Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.
To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
MenABCWY-1
Lot 1 of the MenABCWY vaccine was administered intramuscularly.
MenABCWY-2
Lot 2 of the MenABCWY vaccine was administered intramuscularly.
MenABCWY-3
Lot 3 of the MenABCWY vaccine was administered intramuscularly.
Interventions
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rMenB+OMV NZ vaccine
rMenB+OMV NZ vaccine was administered intramuscularly.
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
MenACWY vaccine was administered intramuscularly.
Placebo
Placebo was administered intramuscularly.
MenABCWY-1
Lot 1 of the MenABCWY vaccine was administered intramuscularly.
MenABCWY-2
Lot 2 of the MenABCWY vaccine was administered intramuscularly.
MenABCWY-3
Lot 3 of the MenABCWY vaccine was administered intramuscularly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written or witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
* Written informed assent obtained from the subject (if applicable) prior to performing any study specific procedure.
* A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first vaccination.
* Healthy subjects as established by medical history physical examination and clinical judgment of the investigator before entering into the study.
* Subjects who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age).
* Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause\*.
* Female subjects of childbearing potential may be enrolled in the 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 until 30 days after completion of Visit 6.
* A female is considered to be of non-childbearing potential prior to menarche and after natural or induced menopause. Natural menopause is recognized to have occurred after 12 consecutive months of amenorrhea for which there is no other obvious pathological or physiological cause. Induced menopause is recognized to have occurred after hysterectomy, after bilateral oophorectomy, or iatrogenic ablation of ovarian function.
Exclusion Criteria
* Current or previous, confirmed or suspected disease caused by N. meningitidis.
* Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.
* Progressive, unstable or uncontrolled clinical conditions.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. History of febrile convulsions should not lead to exclusion.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
* Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.
* Abnormal function or modification of the immune system resulting from:
* Autoimmune disorders or immunodeficiency syndromes.
* Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination until the post-vaccination 3 blood sample (Visit 6). This will mean prednisone - ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.
* Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
* Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Prior/Concomitant therapy
* Use of any investigational or non-registered product other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period.
* Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine/ product or planned administration during the study period until the post-vaccination 3 blood sample (Visit 6).
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the vaccine/product dose(s) until the post-vaccination 3 blood sample (Visit 6). For corticosteroids, this will mean prednisone ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.
Prior/Concurrent clinical study experience
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Other exclusions
* Child in care.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator.
* Any study personnel or immediate dependants, family, or household member.
10 Years
25 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Glendale, Arizona, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Bell Gardens, California, United States
GSK Investigational Site
Canoga Park, California, United States
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Garden Grove, California, United States
GSK Investigational Site
Inglewood, California, United States
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Los Gatos, California, United States
GSK Investigational Site
Cutler Bay, Florida, United States
GSK Investigational Site
Lake City, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Oviedo, Florida, United States
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West Palm Beach, Florida, United States
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Adairsville, Georgia, United States
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Buford, Georgia, United States
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Columbus, Georgia, United States
GSK Investigational Site
Hinesville, Georgia, United States
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Nampa, Idaho, United States
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Oak Brook, Illinois, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Bardstown, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Beverly, Massachusetts, United States
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Fall River, Massachusetts, United States
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Grosse Pointe Woods, Michigan, United States
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Minneapolis, Minnesota, United States
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Petal, Mississippi, United States
GSK Investigational Site
Missoula, Montana, United States
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Missoula, Montana, United States
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The Bronx, New York, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Grants Pass, Oregon, United States
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Greenville, South Carolina, United States
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North Charleston, South Carolina, United States
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West Columbia, South Carolina, United States
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Laredo, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Kaysville, Utah, United States
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Layton, Utah, United States
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Murray, Utah, United States
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Orem, Utah, United States
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Roy, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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South Jordan, Utah, United States
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Syracuse, Utah, United States
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Falls Church, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Cheney, Washington, United States
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Spokane, Washington, United States
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Marshfield, Wisconsin, United States
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Sydney, New South Wales, Australia
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Gold Coast, Queensland, Australia
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Taringa, Queensland, Australia
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Tarragindi, Queensland, Australia
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Geelong, Victoria, Australia
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Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Québec, , Canada
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České Budejovice, , Czechia
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České Budějovice, , Czechia
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Hradec Králové, , Czechia
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Jindřichův Hradec, , Czechia
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Kladno, , Czechia
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Mělník, , Czechia
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Pardubice, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Příbram, , Czechia
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Trutnov, , Czechia
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Týnec nad Sázavou, , Czechia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Espoo, , Finland
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Helsinki, , Finland
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Helsinki, , Finland
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Järvenpää, , Finland
GSK Investigational Site
Kokkola, , Finland
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Oulu, , Finland
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Pori, , Finland
GSK Investigational Site
Seinäjoki, , Finland
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Tampere, , Finland
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Turku, , Finland
GSK Investigational Site
Adana, , Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Eskişehir, , Turkey (Türkiye)
GSK Investigational Site
Izmir, , Turkey (Türkiye)
GSK Investigational Site
Kayseri, , Turkey (Türkiye)
Countries
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References
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Nolan T, Bhusal C, Beran J, Bloch M, Cetin BS, Dinleyici EC, Drazan D, Kokko S, Koski S, Laajalahti O, Langley JM, Ramet M, Richmond PC, Silas P, Tapiero B, Tiong F, Tipton M, Ukkonen B, Ulukol B, Lattanzi M, Trapani M, Willemsen A, Toneatto D; QUINTET study group. Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial. Lancet Infect Dis. 2025 May;25(5):560-573. doi: 10.1016/S1473-3099(24)00667-4. Epub 2024 Dec 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001666-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
205416
Identifier Type: -
Identifier Source: org_study_id
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