[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SK Bioscience Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100624870","phase-3-skyvaricella-nbp608-vaccine-with-lower-potencies-in-healthy-children-aged-12-months-to-12-years-100624870",false,"NCT07415252","SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years","A Phase III, Randomized, Double-blinded, Active-controlled, Multinational, Multicenter Study to Assess the Safety and Immunogenicity of a Two-dose Regimen of SKYVaricella® (NBP608) in Children Aged 12 Months to 12 Years","Inclusion Criteria:\n\nAge\n\n1. Participant must be ≥12 months to ≤12 years of age, at the time of informed consent.\n\n   Type of Participant and Disease Characteristics\n2. Participant is healthy or medically stable, as determined by the investigator through medical history, physical examination, and overall clinical assessment.\n\n   \\* Medically stable condition is defined as no significant change in therapy and no hospitalization for worsening disease within 8 weeks prior to the first study vaccination\n3. Participant's parents\u002FLARs are able and willing to comply with all study procedures and attend all scheduled visits.\n\n   Sex and Contraceptive\u002FBarrier Requirements\n4. Female participants of childbearing potential (i.e., post-menarcheal females) must agree to maintain complete sexual abstinence from heterosexual intercourse, from at least 4 weeks prior to the first study vaccination and through 12 weeks following the second study vaccination (Visit 5).\n5. Female participants of a childbearing potential must have a negative urine pregnancy test at screening; pregnancy testing is not required for those not of childbearing potential.\n\n   Informed Consent\u002FAssent\n6. Participant's parents\u002FLARs are capable of providing signed informed consent, including agreement to comply with the requirements and restrictions specified in this protocol and in the informed consent form (ICF), before initiation of any study-specific procedures. Where applicable, the participant must also be able to provide written assent in accordance with local regulations and IRB\u002FIEC requirements.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \\>38°C), or acute illness within 24 hours prior to any study vaccination (Participant may be enrolled 24 hours after resolution of these symptoms).\n2. History of suspected or laboratory-confirmed VZV infection\n3. Close contact or household exposure to an individual with suspected or laboratory-confirmed VZV infection within 4 weeks prior to the first study vaccination.\n4. Household member(s) considered at high risk of severe VZV infection, including:\n\n   * Immunocompromised individuals\n   * Pregnant women or newborn infants whose mothers lack history of varicella infection or varicella vaccination\n   * Newborn infants born at \\\u003C 28 weeks gestational age.\n5. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.\n6. History of bleeding disorder or thrombocytopenia contraindicating subcutaneous vaccination, based on the investigator's judgment.\n7. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis) to any vaccines or to any components of the study intervention, including gelatin or neomycin.\n8. History of Guillain-Barre syndrome following receipt of any prior vaccines.\n9. Active untreated tuberculosis infection.\n10. Significant unstable chronic or acute illness that, in the investigator's judgment, could pose a risk to the participant's safety, interfere with protocol-specified procedures, or complicate the interpretation of study results.\n11. Any other medical conditions that, in the opinion of the investigator, might interfere with the evaluation of study objectives (e.g., major congenital anomalies, neurological disorders, history of seizure disorders)\n\n    Prior\u002FConcomitant therapy\n12. Prior receipt of any varicella-containing vaccine.\n13. Receipt of any vaccine within 4 weeks prior to the first study vaccination, except influenza vaccine, which may be received ≥ 2 weeks prior, and pneumococcal conjugate vaccine (PCV), for which the last dose of the primary series must have been administered ≥ 8 weeks prior to the first study vaccination.\n14. Receipt of any live-attenuated vaccine within 4 weeks prior to the first study vaccination, or planned receipt of any live-attenuated vaccine through 4 weeks following each study vaccination, if not administered on the same day as the study vaccine.\n15. Receipt of antiviral medications within 4 weeks prior to the first study vaccination, or planned use of antiviral medications at any time during the study through 6 weeks following the second vaccination.\n16. Receipt of salicylates within 2 weeks prior to the first study vaccination, or planned use of salicylates at any time during the study through 6 weeks following the second vaccination.\n17. Receipt of immunoglobulins (except for BeyfortusTM \\[nirsevimab\\]) or any blood products within 24 weeks prior to the first study vaccination, or planned receipt at any time during the study period.\n18. Receipt or planned chronic use (defined as \\> 2 consecutive weeks) of systemic immunosuppressive therapy or immune-modifying medications, including anti-cancer chemotherapy, radiation therapy; or systemic corticosteroids (equivalent to ≥ 1 mg\u002Fkg\u002Fday of prednisone or 20 mg\u002Fday for individuals weighing \\>10 kg) within 24 weeks prior to the first study vaccination throughout the end of the study period (Use of inhaled, topical, or intranasal glucocorticoids is permitted).\n\n    Prior\u002FConcurrent Clinical Study Experience\n19. Participation in another clinical study involving study intervention within 4 weeks (6 months in Korea in accordance with local regulations) prior to the first study vaccination, or concurrent \u002F planned participation in another clinical study involving study intervention during this study.\n\n    Other Exclusions\n20. Investigators, study staff directly involved in conducting the study or supervised by the investigator, and their respective family members.",true,"ALL","12 Months","12 Years",{"count":21,"type":22},780,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this study is to evaluate the safety and immunogenicity of an investigational varicella vaccine in children. Researchers will compare the investigational vaccine, NBP608, with licensed varicella vaccines. The study includes children aged 12 months to 12 years.\n\nApproximately 780 participants will take part in this study. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Some participants will receive two doses, while others will receive one dose, according to the assigned study group.\n\nParticipants will:\n\nReceive two subcutaneous injections of a study vaccine, administered approximately three months apart (if applicable).\n\nVisit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.",[28],"Varicella (Chickenpox)",[30,31,32,33,34],"SKYVaricella","NBP608","Varicella vaccine","Chickenpox vaccine","Pediatric vaccination","NOT_YET_RECRUITING","2026-06-11",{"date":38,"type":39},"2026-06-15","ACTUAL",{"date":41,"type":22},"2026-06-05",{"date":43,"type":22},"2028-01-02",{"name":45,"class":46},"SK Bioscience Co., Ltd.","INDUSTRY",15,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100614535","phase-1-a-phase-iii-dose-finding-study-to-assess-the-safety-reactogenicity-and-immunogenicity-of-a-broadly-protective-sarbecovirus-vaccine-gbp511-in-healthy-adults-100614535","NCT07280858","A Phase I\u002FII, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults.","A 2-Stage, Phase I\u002FII, Active-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults (Aged 18 Years and Older)","Inclusion Criteria:\n\nAge\n\n1. For Stage 1, participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n\n   For Stage 2, participant must be 18 years of age and older, at the time of signing the informed consent.\n\n   Type of Participant and Disease Characteristics\n2. Participants who are healthy as determined by medical evaluation including medical history, vital signs, physical examination, clinical laboratory tests, and medical judgement of the investigator.\n3. Participants who are willing and able to attend all scheduled visits and comply with all study procedures.\n4. Body mass index (BMI) within the range of 18.5-32.0 kg\u002Fm2 (revised) at screening\n5. Participants who received a primary series and at least one booster dose of an authorized COVID-19 vaccine at least 24 weeks prior to the 1st study vaccination.\n\n   Sex and Contraceptive\u002FBarrier Requirements\n6. All participants must agree to be abstinent from heterosexual intercourse or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last study vaccination (See Appendix 10.4 for detailed contraceptive methods).\n7. Women of childbearing potential (WOCBP) with a negative urine or serum pregnancy test at screening.\n\n   \\* Female participants who are surgically sterile (e.g., having undergone a full hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal with at least 12 months amenorrhoea not considered to be caused by any other medical condition, are not subject to a pregnancy test.\n\n   Informed Consent\n8. Participants who are capable of giving signed informed consent as described in Appendix 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol before initiation of any trial-specific procedures.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \\>38°C), or acute illness within 24 hours prior to the 1st study vaccination. Prospective participants with these conditions cannot be included until 24 hours after resolution.\n2. Concurrent or a history of virologically or serologically confirmed SARS-CoV-2 infection, or suspected SARS-CoV-2 infection as determined by the investigator, within 24 weeks prior to the 1st study vaccination.\n3. History of virologically or serologically confirmed SARS-CoV-1, or MERS disease.\n4. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.\n5. Any positive test results for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening.\n6. History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion.\n7. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis) to any vaccines or components of the study intervention.\n8. History of neurologic diseases (e.g., Guillain-Barre syndrome, myelitis, or encephalomyelitis).\n9. History of myocarditis, pericarditis or myopericarditis, as assessed by the investigator, indicating probable or possible myocarditis, pericarditis, or myopericarditis, or demonstrating clinically significant abnormalities that could affect participant safety or the interpretation of study findings.\n10. History of malignancy within 1 year prior to first study vaccination, except for cutaneous non-melanoma malignancy, melanoma-in-situ, or cervical carcinoma in situ that have been fully treated with completed follow-up prior to screening. Malignancy considered to carry minimal risk of recurrence may also be permitted at the discretion of the investigator.\n11. Significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results.\n12. Any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions).\n13. Female participants who are pregnant or breastfeeding.\n\n    Prior\u002FConcomitant therapy\n14. Receipt of any COVID-19 vaccination including investigational vaccines within 24 weeks prior to the 1st study vaccination or planned receipt at any time during the study period.\n15. Receipt of any vaccinations intended to prevent SARS-CoV-1 or MERS, including investigational vaccines.\n16. Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine through 4 weeks after the last study vaccination, except for influenza vaccination, which may be received at least 2 weeks prior to the 1st study vaccination.\n17. Receipt of any immunoglobulins and\u002For blood-derived products within 12 weeks prior to the 1st study vaccination or planned receipt at any time during the study period.\n18. Receipt of immunosuppressive therapy, such as any use of anti-cancer chemotherapy or radiation therapy; or chronic use of systemic corticosteroid (≥10 mg prednisone\u002Fday or equivalent more than 14 consecutive days) within 12 weeks prior to the 1st study vaccination and throughout the entire study period. The use of intranasal, inhaled, topical, or intra-articular corticosteroid is permitted.\n\n    Prior\u002FConcurrent Clinical Study Experience\n19. Participation in another clinical study and receipt of study intervention within 4 weeks prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period.\n\n    Other Exclusions\n20. Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.\n21. Donation of ≥450mL of blood product within 4 weeks prior to screening, or planned donation of blood product from enrollment through 12 weeks after the last study vaccination.","18 Years",{"count":57,"type":22},368,[59,60],"PHASE1","PHASE2","The purpose of this research study is to evaluate the safety of and the body's immune response to single and multiple vaccinations in healthy men and women. We want to find out what effects GBP511 has on you and your health. We are doing this study to find out:\n\nIf the study drug has any side effects when given as single and multiple vaccinations.\n\nIf reactogenicity, an indication that the immune systems is working and is preparing to protect the body against future infection, occurs. This is a normal physical inflammatory response that occurs after vaccination, manifesting as localised reactions that may include pain or redness at the injection site, or systemic symptoms such as headache or fever.\n\nIf immunogenicity which is when GBP511 causes your body to make antibodies against the non-harmful viral proteins contained within GBP511, called 'neutralising antibodies (Nab),' occurs. And if GBP511 will cause the specialised cells of the body's immune system to mount a defence against the non-harmful viral proteins contained within GBP511, called 'cell-mediated immunity (CMI)'.\n\nIn this study, GBP511 will be administered with and without adjuvant, CAS-1. An adjuvant is an ingredient used in some vaccines that help produce a stronger immune response in the people receiving the vaccine and thus helps the vaccine work better.\n\nThis study will recruit approximately 368 participants in total and will be conducted in two stages:\n\nStage 1 will look at two vaccinations with GBP511 when given with and without the CAS-1 adjuvant; and Stage 2 will look at either one or two vaccinations with two candidate GBP511 vaccines chosen from Stage 1 of the study.\n\nParticipants will be required to attend Linear's clinical unit on two separate occasions to receive their two vaccinations. On the first day of dosing (Visit 2\u002FDay 1) and second day of dosing (Visit 5\u002FDay 29), we will be testing a single dose of the study drug in up to 168 healthy volunteers who will be divided into 3 groups. Group 1, Groups 2 and 3 will have 56 people each. These 3 groups will be divided into treatment subgroups, with a total of 6 test subgroups and 3 control subgroups. In all groups, neither you or the study doctor will know what subgroup you are part of, and therefore what treatment (GBP511 or Comirnaty+ placebo) you will receive.",[63,64],"Healthy Participants","Sarbecovirus","RECRUITING","2026-05-12",{"date":68,"type":39},"2026-05-14",{"date":70,"type":39},"2026-01-28",{"date":72,"type":22},"2028-09-12",{"name":45,"class":46},2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":5},"100568354","phase-1-a-study-to-assess-the-safety-reactogenicity-and-immunogenicity-of-sk-japanese-encephalitis-messenger-ribonucleic-acid-mrna-vaccines-gbp560-in-healthy-adults-100568354","NCT06680128","A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults","A 2-Stage, Phase I\u002FII, Active-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)","Inclusion Criteria:\n\n\\[Age\\]\n\n1. For Stage 1, participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n\n   For Stage 2, participant must be 18 years of age and older, at the time of signing the informed consent.\n\n   \\[Type of Participant and Disease Characteristics\\]\n2. Participants who are healthy as determined by medical evaluation including medical history, vital signs, physical examination, clinical laboratory tests and medical judgement of the investigator.\n3. Participants who are willing and able to attend all scheduled visits and comply with all study procedures.\n4. Body mass index (BMI) within the range of 18.5-29.9 kg\u002Fm2 (inclusive) at screening\n\n   \\[Sex and Contraceptive\u002FBarrier Requirements\\]\n5. All participants must agree to be heterosexually inactive or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last study vaccination (Visit 9) (See Appendix 10.4 for detailed contraceptive methods).\n6. Female participants with a negative urine or serum pregnancy test at screening.\n\n   \\* Female participants who are surgically sterile (e.g., having undergone a full hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal with amenorrhea for at least 12 months are not subject to a pregnancy test.\n\n   \\[Informed Consent\\]\n7. Participants who are capable of giving signed informed consent as described in Appendix 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol before initiation of any trial-specific procedures.\n\nExclusion Criteria:\n\n\\[Medical Conditions\\]\n\n1. Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \\>38°C), or acute illness within 24 hours prior to the 1st study vaccination. Prospective participants with these conditions cannot be included until 24 hours after resolution.\n2. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.\n3. Any positive test results for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening.\n4. History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion.\n5. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis, Guillain-Barre syndrome) to any vaccines or components of the study intervention.\n6. History of myocarditis, pericarditis or myopericarditis (including the screening 12-lead ECG results from Stage 1 participants), as assessed by the investigator, indicating probable or possible myocarditis, pericarditis, or myopericarditis, or demonstrating clinically significant abnormalities that could affect participant safety or the interpretation of study findings.\n7. History of JEV infection\u002Fother flaviviruses infection (e.g., Dengue, West Nile, Zika, St. Louis Encephalitis, Yellow fever).\n8. History of malignancy within 1 year prior to the 1st study vaccination (with the exception of malignancy with minimal risk of recurrence at the discretion of the investigator).\n9. Significant unstable chronic or acute illness that, in the opinion of the investigator, might pose a health risk to the participant if enrolled, or could interfere with the protocol-specified activities, or interpretation of study results.\n\n   \\* The AESIs as outlined in Section 8.1.4 should be considered for evaluating the participant\n10. Any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions).\n11. Female participants who are pregnant or breastfeeding.\n12. (Only for Stage 1) Current smoker or a recent smoking history within 12 weeks prior to screening. Occasional smoker who smokes up to 10 cigarettes per month may be allowed to participate at the investigator's discretion.\n\n    \\[Prior\u002FConcomitant medication\\]\n13. Receipt of JEV vaccination\u002Fother flaviviruses vaccination in the past.\n14. Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine from enrollment through 4 weeks after the last study vaccination (Visit 8), except for inactivated influenza vaccination, which may be received at least 2 weeks prior to the 1st study vaccination.\n15. Receipt of immunoglobulins and\u002For any blood or blood-derived products within 12 weeks prior to the 1st study vaccination.\n16. Receipt of immunosuppressive therapy, such as any use of anti-cancer chemotherapy or radiation therapy; or systemic corticosteroid therapy (≥10 mg prednisone\u002Fday or equivalent) within 12 weeks prior to the 1st study vaccination. The use of inhaled, topical, or nasal glucocorticoid will be permitted.\n\n    \\[Prior\u002FConcurrent Clinical Study Experience\\]\n17. Participation in another clinical study and receipt of study intervention within 4 weeks prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period.\n\n    \\[Other Exclusions\\]\n18. Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.\n19. Donation of ≥ 450mL (milliliter) of blood product within 4 weeks prior to screening, or planned donation of blood product from enrollment through 12 weeks after the last study vaccination (Visit 9).",{"count":83,"type":22},402,[59,60],"This is a 2-Stage, Phase I\u002FII Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)",[87],"Japanese Encephalitis Virus Disease","2025-12-16",{"date":90,"type":39},"2025-12-23",{"date":92,"type":39},"2025-02-24",{"date":94,"type":22},"2028-03-19",{"name":45,"class":46},""]