[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583669":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":79,"locations":85,"responsibleParty":116,"collaborators":118,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":40,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":40,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":88,"whyStopped":40,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"PATH","OTHER",[8,21,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Compressed 6-10-14 Week Schedule: R21\u002FMM Malaria Vaccine","EXPERIMENTAL","Participants will receive R21\u002FMM malaria vaccination at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, pneumococcal conjugate vaccine (PCV), and oral rotavirus vaccine (RV). At 9 months of age participants will receive measles-rubella (MR) vaccine, yellow fever (YF) vaccine, and typhoid conjugate vaccine (TCV).\n\nParticipants will receive a booster dose of R21\u002FMM malaria vaccine at 15 months of age co-administered with Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (MenFive) and the 2nd dose of MR vaccine.",[13,14,15,16,17,18,19,20],"Biological: R21 Matrix-M (R21\u002FMM) Malaria Vaccine","Biological: Hexavalent Vaccine","Biological: Pneumococcal Polysaccharide Conjugate Vaccine","Biological: Rotavirus, Live Attenuated (Oral) Vaccine","Biological: Measles and Rubella Vaccine","Biological: Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine","Biological: Yellow Fever vaccine","Biological: Typhoid Conjugate vaccine",{"label":22,"type":6,"description":23,"interventionNames":24},"Compressed 6-10-14 Week Schedule: Placebo \u002F Recommended 5-6-7 Month Schedule: R21\u002FMM Malaria Vaccine","Participants will receive placebo at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, PCV, and oral RV. After completion of the 28 day post-Dose 3 visit, these participants will rollover to Cohort 4 (Group 7) to then receive open-label R21\u002FMM vaccine as per the \"recommended\" schedule at 5-6-7 months of age.\n\nAt 9 months of age participants will receive MR and YF vaccines and TCV. Participants will receive a booster dose of R21\u002FMM malaria vaccine at 15 months of age co-administered with the MenFive vaccine and the 2nd dose of MR vaccine.",[13,25,14,15,16,17,18,19,20],"Biological: Placebo",{"label":27,"type":10,"description":28,"interventionNames":29},"Relaxed 2-4-6 Month Schedule: R21\u002FMM Malaria Vaccine","Participants will receive R21\u002FMM malaria vaccination at 2, 4, and 6 months of age co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines and TCV.\n\nParticipants will receive a booster dose of R21\u002FMM malaria vaccine at 15 months of age co-administered with the MenFive vaccine and the 2nd dose of MR vaccine.",[13,14,15,16,17,18,19,20],{"label":31,"type":10,"description":32,"interventionNames":33},"Relaxed 3-6-9 Month Schedule: R21\u002FMM Malaria Vaccine","Participants will receive R21\u002FMM malaria vaccination at 3, 6, and 9 months of age. Participants will receive the hexavalent vaccine, PCV, and oral RV at 6 weeks, 10 weeks, and 14 weeks of age. At 9 months of age participants will receive MR and YF vaccines and TCV.\n\nParticipants will receive a booster dose of R21\u002FMM malaria vaccine at 15 months of age co-administered with the MenFive vaccine and the 2nd dose of MR vaccine.",[13,14,15,16,17,18,19,20],[35,41,45,51,57,63,67,71,75],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BIOLOGICAL","R21 Matrix-M (R21\u002FMM) Malaria Vaccine","Administered by intramuscular injection. Each 0.5 mL dose contains R21 Malaria Antigen (5 mcg) and Matrix-M1 (Adjuvant) (50 mcg).",[22,9,27,31],null,{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"Placebo","Administered by intramuscular injection. Each dose (0.5 mL) contains Normal saline (0.9%).",[22],{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Hexavalent Vaccine","Administered by intramuscular injection. Each dose of 0.5 mL contains:\n\n* Diphtheria Toxoid \\> 30 IU\n* Tetanus Toxoid \\> 40 IU\n* B. pertussis (whole cell) \\> 4 IU\n* Hepatitis B surface antigen (HBsAg) (recombinant DNA) 15 mcg\n* Inactivated polio vaccine (Salk strains grown on vero cells): Type - 1 (Mahoney strain) 40 D antigen units (DU); Type - 2 (MEF-1 strain) 8 DU; Type - 3 (Saukett strain) 32 DU\n* Haemophilus influenzae Type b (Hib) Conjugate Vaccine (Adsorbed) polyribosylribitol phosphate (PRP) 10 mcg conjugated to tetanus toxoid (TT) (carrier protein) 19 to 33 mcg\\]",[22,9,27,31],[50],"HEXASIIL",{"type":36,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Pneumococcal Polysaccharide Conjugate Vaccine","Administered by intramuscular injection. Each 0.5 mL dose contains 2 mcg each Saccharide for serotypes 1, 5, 9V, 14, 19A, 19F, 23F, 7F, 6A and 4 mcg Saccharide for serotype 6B.",[22,9,27,31],[56],"PNEUMOSIL",{"type":36,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Rotavirus, Live Attenuated (Oral) Vaccine","Administered orally. Each 2.0 mL dose contains: Live Attenuated Bovine-Human Rotavirus Reassortant \\[G1, G2, G3, G4 and G9\\], 5.6 focus-forming units (FFU) \u002F serotype.",[22,9,27,31],[62],"ROTASIIL",{"type":36,"name":64,"description":65,"armGroupLabels":66,"otherNames":40},"Measles and Rubella Vaccine","Administered by subcutaneous injection. Each 0.5 mL dose contains not less than 1000 cell culture infectious dose 50% (CCID50) of Measles virus and 1000 CCID50 of Rubella virus.",[22,9,27,31],{"type":36,"name":68,"description":69,"armGroupLabels":70,"otherNames":40},"Meningococcal (A, C, Y, W, X) polysaccharide conjugate vaccine","Administered by intramuscular injection. Each 0.5 mL dose contains 5 mcg of each Meningococcal A, C, Y, W, and X polysaccharide, 7.8 to 33.4 mcg of TT and 11.7 to 50.1 mcg of recombinant CRM197.",[22,9,27,31],{"type":36,"name":72,"description":73,"armGroupLabels":74,"otherNames":40},"Yellow Fever vaccine","Yellow fever vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.",[22,9,27,31],{"type":36,"name":76,"description":77,"armGroupLabels":78,"otherNames":40},"Typhoid Conjugate vaccine","Typhoid conjugate vaccine will be locally sourced by each trial site in accordance with the countries' EPI program.",[22,9,27,31],[80],{"name":81,"role":82,"phone":83,"phoneExt":40,"email":84},"Michael Thigpen, MD","CONTACT","+1 202 822 0033","mthigpen@path.org",[86,103],{"facility":87,"status":88,"city":89,"state":40,"zip":40,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Institut de Recherche en Sciences de la Santé (IRSS)","RECRUITING","Bobo-Dioulasso","Burkina Faso","BF",{"type":93,"coordinates":94},"Point",[95,96],-4.29489,11.18064,{"lat":96,"lon":95},[99],{"name":100,"role":82,"phone":101,"phoneExt":40,"email":102},"Issaka Zongo, MD, PhD","226 70 78 22 74","zongoissaka08@gmail.com",{"facility":104,"status":88,"city":105,"state":40,"zip":40,"country":90,"countryCode":91,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Groupe de Recherche Action en Santé (GRAS)","Ouagadougou",{"type":93,"coordinates":107},[108,109],-1.53388,12.36566,{"lat":109,"lon":108},[112],{"name":113,"role":82,"phone":114,"phoneExt":40,"email":115},"Sodiomon Sirima, MD, BA, PhD","226 25 35 56 90","s.sirima@gras.bf",{"type":117,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[119,122,124,127,129],{"name":120,"class":121},"Pharmassist Ltd","INDUSTRY",{"name":123,"class":121},"Serum Institute of India Pvt. Ltd.",{"name":125,"class":126},"Agilis","UNKNOWN",{"name":128,"class":126},"MCT-CRO",{"name":130,"class":126},"Cytespace","100583669","phase-2-infant-malaria-vaccine-schedule-optimization-100583669",false,"NCT06879327","Infant Malaria Vaccine Schedule Optimization","A Phase 2b Multicenter Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of R21\u002FMatrix-M Malaria Vaccine in African Infants With Different Immunization Schedules","Inclusion Criteria:\n\n* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent\u002Flegal guardian of the infant.\n* Infants must have been born full-term (at ≥37 weeks of gestation) and \\> 2500 grams at birth.\n* Immunization schedule Cohorts 1, 2, and 3: Male and female infants 42-49 days (inclusive) of age at time of enrollment.\n* Prior to group randomization, for infants in Cohort 1 randomization to receive vaccine dose 1 (Groups 1 and 2 of R21\u002FMM or placebo, respectively) will occur at 42-49 days of age. Infants in Cohorts 2 and 3 will not be randomized to R21\u002FMM or placebo; placebo will no longer be given. Rather infants in these cohorts will receive open-label R21\u002FMM according to the immunization schedule category to which they have been randomized. Infants in Cohort 2, will receive their open-label R21\u002FMM vaccine dose 1 (Group 3) at 2 months (56-63 days of age). Infants in Cohort 3, will receive their open-label R21\u002FMM vaccine dose 1 (Group 5) at 3 months (84-91 days of age).\n* The participant's parent\u002Fguardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness to contact the study team in the event of unexpected\u002Funavoidable travel and, for the safety cohort, must confirm availability for the home visits to be conducted by a field worker or nurse to collect solicited AEs over the 7 days (day of vaccination and 6 subsequent days) following each study vaccine.\n* The participant's parent\u002Fguardian must confirm willingness to bring their child to the study clinic \u002F local health care clinic, and capacity to contact the study team in the event the subject has any illnesses or other health concerns during the study.\n* Participants who the investigator believes that their parent\u002Fguardian can and will comply with the requirements of the protocol (e.g. return for follow-up visits) may be enrolled in the study.\n\nExclusion Criteria:\n\n• Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever). This does not include minor illnesses such as diarrhea, mild upper respiratory infection, without low-grade febrile illness, i.e. axillary temperature \\\u003C 37.5°C or tympanic temperature \\\u003C 38°C.\n\n(Note: In case of acute disease, participants may be re-assessed by a study physician for resolution of the condition and enrolled if eligible and still within the visit window).\n\n* Clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial.\n* At time of enrollment, any infant who has received any dose of the hexavalent\u002Fpentavalent vaccines, pneumococcal vaccine, rotavirus vaccine, IPV or has received more than one dose of oral polio virus or more than one dose of hepatitis B vaccine.\n* Weight-for-length\u002Fheight Z score of less than -3 or other clinical signs of malnutrition.\n* Infant with major congenital defects.\n* The infant has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g\u002FdL.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Any confirmed or suspected immunosuppressive or immunodeficient state (including HIV or asplenia) or known maternal HIV infection (no HIV testing will be routinely done by the study team).\n* Administration of immunoglobulins and\u002For any blood products\u002Fblood transfusion from birth to time of planned administration of the vaccine candidate.\n* Previous vaccination of participant or biological mother with a malaria vaccine.\n* Participation in another research study involving receipt of an investigational product or planned use during the study period.\n* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.",true,"ALL","42 Days","49 Days",{"count":143,"type":144},964,"ESTIMATED","INTERVENTIONAL",[147],"PHASE2","The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.",[150],"Malaria Vaccines",[152,153],"Plasmodium falciparum","R21\u002FMatrix-M Malaria Vaccine","2026-05-13",{"date":156,"type":157},"2026-05-15","ACTUAL",{"date":159,"type":157},"2025-05-30",{"date":161,"type":144},"2027-09-27",{"name":5,"class":6},2]