[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07003984":3,"trial-entities:NCT07003984":351,"trial-summary:NCT07003984":354},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":49,"secondary_outcomes":62,"sex":102,"minimum_age":103,"maximum_age":104,"healthy_volunteers":15,"eligibility_criteria":105,"std_ages":112,"locations":114,"central_contacts":327,"overall_officials":334,"references":339,"see_also_links":350},"NCT07003984","EBSI-CV-317-006","A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.","A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to \u003C12 Years of Age","RECRUITING","2028-12","2026-03","2026-03-24","2025-06-05","Bavarian Nordic","INDUSTRY",true,"The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to \\\u003C12 years of age.",null,[19],"Chikungunya Virus",[21,22,23,24,25,26,27],"Chikungunya","PXVX0317","CHIKV VLP","vaccine","immunogenicity","VIMKUNYA","children","INTERVENTIONAL","PREVENTION",[31],"PHASE3",{"count":33,"type":34},720,"ESTIMATED",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BIOLOGICAL","CHIKV VLP vaccine","CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%",[41,42],"Arm 1","Arm 3",{"type":37,"name":44,"description":45,"armGroupLabels":46},"Placebo","Placebo is comprised of formulation buffer",[47,48],"Arm 2","Arm 4",[50,54,58],{"measure":51,"description":52,"timeFrame":53},"Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs","Incidence of adverse events of special interest (AESIs; defined as new onset or worsening arthralgia that is medically attended), medically attended adverse events (MAAEs), and serious adverse events (SAEs) through end of the trial.","From vaccination through the end of the trial, planned to be Day 732 for study completers.",{"measure":55,"description":56,"timeFrame":57},"Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children","Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to \\\u003C12 years of age in the immunogenicity evaluable population.","Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.",{"measure":59,"description":60,"timeFrame":61},"Safety Endpoint 2: Incidence of unsolicited AEs through Day 29","Incidence of unsolicited adverse events (AEs) through Day 29.","From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.",[63,66,70,74,77,81,85,89,92,95,99],{"measure":64,"description":65,"timeFrame":57},"Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children","Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to \\\u003C12 years of age in the immunogenicity evaluable population.",{"measure":67,"description":68,"timeFrame":69},"Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children","Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to \\\u003C12 years of age in the immunogenicity evaluable population.","Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.",{"measure":71,"description":72,"timeFrame":73},"Safety Endpoint 1: Incidence of solicited adverse events through Day 8","Incidence of solicited adverse events through Day 8.","From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.",{"measure":75,"description":76,"timeFrame":69},"Key Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children","Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to \\\u003C12 years of age in the immunogenicity evaluable population.",{"measure":78,"description":79,"timeFrame":80},"Secondary Immunogenicity Endpoint 2: Day 183 and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children","Day 183 and Day 366 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to \\\u003C12 years of age in the immunogenicity evaluable population.","Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.",{"measure":82,"description":83,"timeFrame":84},"Secondary Immunogenicity Endpoint 3: Day 15, Day 22, Day 183, and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children","Day 15, Day 22, Day 183, and Day 366 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to \\\u003C12 years of age in the immunogenicity evaluable population, stratified by age stratum (1 to \\\u003C6 and 6 to \\\u003C12 years); analyzed by baseline serostatus separately and combined.","Day 15, Day 22, Day 183, and Day 366, 14, 21, 182, and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.",{"measure":86,"description":87,"timeFrame":88},"Secondary Immunogenicity Endpoint 4: GMTs of anti-CHIKV SNA at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only","Geometric mean titers (GMTs) of anti-CHIKV serum neutralizing antibodies (SNA) at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only, in children 1 to \\\u003C12 years of age in the immunogenicity evaluable population by age stratum (1 to \\\u003C6 and 6 to \\\u003C12 years); analyzed by baseline serostatus separately and combined.","Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.",{"measure":90,"description":91,"timeFrame":88},"Secondary Immunogenicity Endpoint 5a: GMFIs from Day 1 to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only","Geometric mean fold increases (GMFIs) from Day 1 (prevaccination) to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only in children 1 to \\\u003C12 years of age in the IEP and by age stratum (1 to \\\u003C6 and 6 to \\\u003C12 years); analyzed by baseline serostatus separately and combined.",{"measure":93,"description":94,"timeFrame":88},"Secondary Immunogenicity Endpoint 5b: Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only","Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only in children 1 to \\\u003C12 years of age in the IEP and by age stratum (1 to \\\u003C6 and 6 to \\\u003C12 years); analyzed by baseline serostatus separately and combined.",{"measure":96,"description":97,"timeFrame":98},"Secondary Immunogenicity Endpoint 6: Anti-CHIKV SNA seroresponse rates at Day 732 in the CHIKV VLP vaccine group only","For the CHIKV VLP vaccine group only, anti-CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 732 in both baseline seronegative and seropositive children 1 to \\\u003C12 years of age and by age stratum (1 to \\\u003C6 and 6 to \\\u003C12 years); analyzed by baseline serostatus separately and combined.","Study Day 732, 731 days after vaccination with CHIKV VLP vaccine.",{"measure":100,"description":101,"timeFrame":57},"Secondary Immunogenicity Endpoint 7: Day 22 anti-CHIKV SNA seroresponse rate between seronegative children in the IEP versus adolescents and adults study EBSI-CV-317-004","Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate between baseline seronegative children 1 to \\\u003C12 years of age in the immunogenicity evaluable population (IEP) versus adolescents and adults from 12 to \\\u003C65 years of age in study EBSI-CV-317-004.","ALL","1 Year","11 Years",{"inclusion":106,"exclusion":107,"raw_text":111},[],[108,109,110],"A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.","Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.","Another licensed or investigational CHIKV vaccine. 9. Known infection with human immunodeficiency virus, hepatitis C virus (HCV), or hepatitis B virus. Note: Positive anti-HCV antibodies and negative HCV polymerase chain reaction would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol. 10. Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator. 11. Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study. 12. Onset of menarche prior to study vaccination. 13. Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study. 14. Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study. 15. Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study.","Inclusion Criteria:\n\n1. Males or females between 1 and \\\u003C12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active\u002Fopen cohorts. Please see Section 6.1 for details\n2. Body weight ≥6.5 kg.\n3. In general good health, in the opinion of the investigator, based on medical history and physical examination.\n4. Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.\n5. Able and willing to complete all scheduled visits and comply with all study procedures.\n\nExclusion Criteria:\n\n1. Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment.\n2. Current acute illness, with or without fever.\n3. Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.\n4. History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.\n5. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.\n6. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day 22. Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg or greater (≥0.5 mg\u002Fkg for children \\\u003C40 kg) of prednisone for 14 consecutive days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.\n7. Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.\n8. Any administration or planned administration of:\n\n   * A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.\n   * Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.\n   * Another licensed or investigational CHIKV vaccine.\n9. Known infection with human immunodeficiency virus, hepatitis C virus (HCV), or hepatitis B virus. Note: Positive anti-HCV antibodies and negative HCV polymerase chain reaction would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol.\n10. Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.\n11. Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.\n12. Onset of menarche prior to study vaccination.\n13. Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.\n14. Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study.\n15. Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study.",[113],"CHILD",[115,133,149,164,175,190,205,220,235,250,262,275,290,303,312],{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":120,"contacts":121,"geoPoint":130},"ARK Clinical Research, LLC","Fountain Valley","California","92708","United States",[122,127],{"name":123,"role":124,"phone":125,"email":126},"Angel Galvez","CONTACT","562-997-1000","agalvez@arkclinicalresearch.com",{"name":128,"role":129},"Justin Yanuck","PRINCIPAL_INVESTIGATOR",{"lat":131,"lon":132},33.70918,-117.95367,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":120,"contacts":138,"geoPoint":146},"Emerson Clinical Research Institute- DC","Washington D.C.","District of Columbia","20009",[139,144],{"name":140,"role":124,"phone":141,"phoneExt":142,"email":143},"Andres Jimenez","202-239-0777","106","andres@ecrinstitute.com",{"name":145,"role":129},"Julie Pineda, MD",{"lat":147,"lon":148},38.89511,-77.03637,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":120,"contacts":154,"geoPoint":161},"Acevedo Clinical Research","Miami","Florida","33142",[155,159],{"name":156,"role":124,"phone":157,"email":158},"Jonathan Castano","305-649-8871","j.castano@acevedoclinicalresearch.com",{"name":160,"role":129},"Giselle Deiros, MD",{"lat":162,"lon":163},25.77427,-80.19366,{"facility":165,"status":8,"city":151,"state":152,"zip":166,"country":120,"contacts":167,"geoPoint":174},"Hope Research Network","33166",[168,172],{"name":169,"role":124,"phone":170,"email":171},"Jose Rafael Gonzalez","786-953-8858","jgonzalez@hoperesearchnetwork.com",{"name":173,"role":129},"Mario Reyes, MD",{"lat":162,"lon":163},{"facility":176,"status":8,"city":177,"state":178,"zip":179,"country":120,"contacts":180,"geoPoint":187},"Velocity Clinical Research-Omaha","Omaha","Nebraska","68134",[181,185],{"name":182,"role":124,"phone":183,"email":184},"Nathaniel Frazier","402-933-6500","nfrazier@velocityclinical.com",{"name":186,"role":129},"Frederick Raiser, DO",{"lat":188,"lon":189},41.25626,-95.94043,{"facility":191,"status":8,"city":192,"state":193,"zip":194,"country":120,"contacts":195,"geoPoint":202},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[196,200],{"name":197,"role":124,"phone":198,"email":199},"Julie Kulhanek","513-803-2109","Julie.Kulhanek@cchmc.org",{"name":201,"role":129},"Robert Frenck, MD",{"lat":203,"lon":204},39.12711,-84.51439,{"facility":206,"status":8,"city":207,"state":208,"zip":209,"country":120,"contacts":210,"geoPoint":217},"KidCare Pediatrics","Beaumont","Texas","77706",[211,215],{"name":212,"role":124,"phone":213,"email":214},"Alea White","409-234-1678","awhite@tektonresearch.com",{"name":216,"role":129},"Robert Codey Bell, MD",{"lat":218,"lon":219},30.08605,-94.10185,{"facility":221,"status":8,"city":222,"state":223,"zip":224,"country":120,"contacts":225,"geoPoint":232},"Velocity Clinical Research - Salt Lake City","West Jordan","Utah","84088",[226,230],{"name":227,"role":124,"phone":228,"email":229},"Caitlan Peterson","801-542-8190","cpeterson@velocityclinical.com",{"name":231,"role":129},"Barbara Rizzardi, MD",{"lat":233,"lon":234},40.60967,-111.9391,{"facility":236,"status":8,"city":237,"state":238,"zip":239,"country":240,"contacts":241,"geoPoint":247},"CARE CT Group Inc.","Dasmariñas","Cavite","4114","Philippines",[242,245],{"name":243,"role":124,"email":244},"Andre L Agoncillo","miguelmaralitmd@yahoo.com",{"name":246,"role":129},"Delia C Yu, MD",{"lat":248,"lon":249},14.32944,120.93667,{"facility":251,"status":8,"city":252,"state":238,"zip":253,"country":240,"contacts":254,"geoPoint":260},"HIMC Research and Development on Medical Sciences","Imus","4103",[255,258],{"name":256,"role":124,"email":257},"Maria Papa","healthindexmsc@yahoo.com",{"name":259,"role":129},"Edison Alberto, MD",{"lat":261,"lon":249},14.42972,{"facility":263,"status":8,"city":264,"state":238,"zip":265,"country":240,"contacts":266,"geoPoint":272},"Silang Specialist Medical Center","Silang","4118",[267,270],{"name":268,"role":124,"email":269},"Y'von L Millora","ssmcresearch@smail.com",{"name":271,"role":129},"Maria T Gler, MD",{"lat":273,"lon":274},14.21567,120.97137,{"facility":276,"status":277,"city":278,"state":279,"zip":280,"country":240,"contacts":281,"geoPoint":287},"University of Perpetual Help DALTA Medical Center, Biomedical Research Institute","NOT_YET_RECRUITING","Las Piñas","National Capital Region","1740",[282,285],{"name":283,"role":124,"email":284},"Maria L Magboo-Gaviola","cor_uphs@yahoo.com.ph",{"name":286,"role":129},"Mitzi C Trinidad-Aseron, MD",{"lat":288,"lon":289},14.45056,120.98278,{"facility":291,"status":8,"city":292,"state":279,"zip":293,"country":240,"contacts":294,"geoPoint":300},"Institute of Child Health and Human Development, University of the Philippines","Manila","1000",[295,298],{"name":296,"role":124,"email":297},"Michael Tee","oc@upm.edu.ph",{"name":299,"role":129},"Michelle C Ylade, MD",{"lat":301,"lon":302},14.6042,120.9822,{"facility":304,"status":277,"city":292,"zip":305,"country":240,"contacts":306,"geoPoint":311},"University of the Philippines-Philippine General Hospital","100",[307,309],{"name":308,"role":124,"email":297},"Michael L Tee",{"name":310,"role":129},"Maria E Uy, MD",{"lat":301,"lon":302},{"facility":313,"status":8,"city":314,"state":315,"zip":316,"country":315,"contacts":317,"geoPoint":324},"CMRC Headlands LLC","San Juan","Puerto Rico","918",[318,322],{"name":319,"role":124,"phone":320,"email":321},"Carmen Navarro","787-679-3324","cnavarro@cmrcenter.com",{"name":323,"role":129},"Carmen Deseda, MD",{"lat":325,"lon":326},18.46633,-66.10572,[328,332],{"name":329,"role":124,"phone":330,"email":331},"Priya Uppin","844-422-8274","info@bavarian-nordic.com",{"name":333,"role":124,"email":331},"Faye Cross",[335],{"name":336,"affiliation":337,"role":338},"Patrick Ajiboye, MD","Bavarian Nordic A\u002FS","STUDY_DIRECTOR",[340,344,347],{"pmid":341,"type":342,"citation":343},"35709798","BACKGROUND","Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016\u002FS1473-3099(22)00226-2. Epub 2022 Jun 13.",{"pmid":345,"type":342,"citation":346},"37690874","McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, Tredo SR, Warfield KL, Richardson JS. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016\u002Fj.vaccine.2023.08.086. Epub 2023 Sep 9.",{"pmid":348,"type":342,"citation":349},"40158526","Richardson JS, Anderson DM, Mendy J, Tindale LC, Muhammad S, Loreth T, Tredo SR, Warfield KL, Ramanathan R, Caso JT, Jenkins VA, Ajiboye P, Bedell L; EBSI-CV-317-004 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1343-1352. doi: 10.1016\u002FS0140-6736(25)00345-9. Epub 2025 Mar 27.",[],{"nct_id":4,"conditions":352,"biomarkers":353},[21],[],{"nct_id":4,"found":15,"summary":355,"prompt_version":17},{"design":356,"status":357,"heading":358,"summary":359,"follow_up":360,"word_count":361,"commitments":362,"compensation":363,"drugs_mentioned":364},"This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the vaccine or placebo, and neither you nor the study team will know which you receive. It plans to enroll 720 children.","completed","CHIKV VLP Vaccine Study in Children","This study is testing a vaccine called CHIKV VLP vaccine to see if it's safe and if it helps children's bodies fight off the Chikungunya virus. The vaccine uses \"virus-like particles\" (VLPs), which are tiny parts of the virus that can't cause illness but can teach the body to protect itself. Some children will receive the CHIKV VLP vaccine, while others will receive a placebo (a substance with no active medicine). We are looking for children between 1 and 11 years old who are generally healthy and weigh at least 6.5 kg. The study will measure how safe the vaccine is by tracking any side effects and how well it helps the body create a protective response against the virus. The study plans to enroll 720 children.","Participants will be followed for safety through the end of the trial, planned to be Day 732 (about 2 years) for those who complete the study.",127,"Not specified in the trial record.","Not stated in the trial record.",[38,44]]