[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumococcal-vaccines\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumococcal-vaccines":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100578909","phase-4-opportunistic-pneumococcal-immunisation-trial-in-malnutrition-100578909",false,"NCT06817421","Opportunistic Pneumococcal Immunisation Trial in MALnutrition","Immunogenicity of Opportunistic Pneumococcal Conjugate Vaccination (Pneumosil®) Versus Control (Typhoid Conjugate Vaccine, Typbar TCV®) in Children Aged 6-59 Months Hospitalised With Severe Acute Malnutrition: a Single-centre, Double-blind, Randomised Controlled Trial in Timor-Leste","OPTIMAL","Inclusion Criteria:\n\n1. Aged 6-59 months at the time of hospitalisation\n2. Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c):\n\n   1. weight-for-length\u002Fheight z-score \\\u003C-3; or\n   2. middle upper arm circumference \\\u003C11.5cm; or\n   3. bilateral pitting pedal oedema unexplained by other causes\n3. Parent\u002Fcarer is willing for their child to participate in the study and has provided written informed consent\n4. Parent\u002Fcarer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study\n\nExclusion Criteria:\n\n1. Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock.\n2. Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial.\n3. Suspected primary or secondary immunodeficiency or prolonged administration (\\>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months.\n4. Known terminal illness expected to result in death within 6 months.\n5. Participants who, in the opinion of the site Principal Investigator, are unable to comply with the study protocol, including scheduled visits, assessments, and any other protocol-required procedures.\n6. Previously enrolled in this trial.","ALL","6 Months","59 Months",{"count":21,"type":22},214,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of the OPTIMAL clinical trial is to learn if a dose of a pneumococcal conjugate vaccine (PCV) generates a good immune response in young children who are in hospital with severe acute malnutrition.\n\nResearchers will compare an intervention group who get a dose of a PCV (Pneumosil) to a control group who get a dose of a Typhoid conjugate vaccine (Typbar TCV). To ensure all participants receive timely potential benefits, at 3 months participants in the intervention group with receive a dose of Typbar TCV, and those in the conrol group will receive a dose of Pneumosil.\n\nParticipants will be visited 4 times at their homes over six months after vaccination, with a phone review at 12 months after vaccination.",[28,29,30,31,32],"Severe Acute Malnutrition in Childhood","Pneumococcal Disease","Pneumococcal Vaccines","Pneumococcal Infection","Pneumonia in Children",[34,35,36,37,38,39,40],"Pneumococcal","Severe Acute Malnutrition in childhood","Pneumococcal vaccine","Pneumosil","Pneumococcal disease","Pneumococcal infection","Pneumonia","NOT_YET_RECRUITING","2025-12-10",{"date":44,"type":45},"2025-12-18","ACTUAL",{"date":47,"type":22},"2026-01",{"date":49,"type":22},"2029-02",{"name":51,"class":52},"Nick Fancourt","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100536965","phase-4-evaluation-of-pcv21-vaccination-among-ppsv23-experienced-immunocompromised-elderly-veterans-100536965","NCT06271681","Evaluation of PCV21 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans","Inclusion Criteria:\n\n* Subject meets the CDC definition of an immunocompromising condition\n\n  o chronic renal failure, congenital or acquired asplenia, generalized malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, sickle cell disease or other hemoglobinopathies, and solid organ transplant.\n* Have received at least 1 dose of PPSV23\n\nExclusion Criteria:\n\n* Less than 5 years since last receipt of PPSV23 validated to patient medical record and Immunize Nevada Website\n* Previous administration of PCV20\n* Previous administration of PCV13\n* Previous administration of PCV15\n* Less than 14 days since administration of any COVID19 vaccination\n* Previous history of Invasive Pneumococcal Disease (IPD)\n* Antibiotic treatment within the previous 90 days",{"count":61,"type":22},45,[25],"The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster with of 21-valent pneumococcal conjugate vaccine . Immune response will be assessed by opsonophagocytic assay reactivity.",[30,65],"Immunosuppression",[67,68],"immunosuppression","pneumococcal vaccines","2025-08-08",{"date":71,"type":45},"2025-08-14",{"date":73,"type":22},"2026-01-01",{"date":75,"type":22},"2027-06-01",{"name":77,"class":78},"VA Sierra Nevada Health Care System","FED",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":5},"100562825","phase-3-a-phase-3-study-to-evaluate-the-immunogenicity-and-safety-of-minhais-pcv13-dttt-vaccine-as-compared-to-pfizers-pcv13-vaccine-100562825","NCT06608199","A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT\u002FTT Vaccine As Compared to Pfizer's PCV13 Vaccine","A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered with Hexavalent Vaccine At 2, 4 and 12-15 Months of Age to Healthy Infants in Indonesia","Inclusion Criteria:\n\n1. Healthy infants based on medical history and clinical assessment.\n2. Infants age of 6-8 weeks at enrolment. Infants will be eligible since the day they reach 6 weeks of age and until 8 weeks of age included.\n3. \\*Body weight at enrollment ≥3.0 kg (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).\n4. \\*On the day of vaccination and within 3 days prior to 1st dose of vaccination, axillary temperatures \\<37.5°C\u002F99.1°F (If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.).\n5. Infant's parent(s) or legal guardian must be able and willing to provide voluntary written\u002Fthumb-printed informed consent for the infant to participate in the study.\n6. Infant's parent(s) or legal guardian must be willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.\n7. The infant's mother must provide related medical certificate(s) for the negative results for HIV, HBV and syphilis infection within 1 year prior to screening.\n8. Infant's parent(s) or legal guardian must have a readily identifiable place of residence in the study area, be available for the duration of trial participation, and have a means of telephone contact.\n\nNote: For items with an asterisk (\\*), If the subject does not meet the criteria, the visit may be rescheduled when the criteria is met.\n\nExclusion Criteria:\n\n1. Use of any investigational product other than that used in the study prior to randomization or planned use of such a product during the period of study participation.\n2. History of S. pneumoniae infection as confirmed by laboratory testing if available.\n3. The infant who are children in care, preterm and low-birth-weight (Preterm infants have a gestational age below 37 weeks at birth and low-birth-weight infants have a birth weight below 2.5 kg).\n4. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine. And\u002For all components of the hexavalent vaccine.\n5. History of anaphylactic shock.\n6. Any abnormal vital sign as judged by the investigator.\n7. \\*Participant experiences acute diseases or acute exacerbation of chronic diseases or uses antipyretic, analgesic and anti-allergic drugs (such as paracetamol, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days before vaccination.\n8. \\*History of administration of attenuated vaccines within 14 days (\\<14 days) and inactivated vaccines within 7 days (\\<7 days) prior to the 1st dose of investigational vaccine (If the participant\\[s\\] does not meet the criteria, the visit may be rescheduled when the criteria are met).\n9. Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and\u002For Streptococcus pneumoniae with the exception of vaccines where the first dose can be given before 2 months of life according to the national recommendations.\n10. History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.\n11. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥10 mg\u002Fday of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled\u002Fnebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids within indicated dosage are permitted.\n12. \\*Administration of immunoglobulins and\u002For any blood products or anticipation of such administration within 28 days before vaccination and during the study period.\n13. History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g., thalassemia, coagulation factors deficiency, severe anemia at birth).\n14. History of suspected primary immunodeficiency.\n15. History of meningitis, seizures or any neurological disorder.\n16. A family history of congenital or hereditary immunodeficiency.\n17. The infant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the investigator, study site personnel.\n18. Any medical or social condition that in the opinion of the investigator may compromise the well-being of the study participant, interfere with the study objectives, pose a risk to the study participant, or prevent the study participant from completing the study follow-up.\n\nNote: For items with an asterisk (\\*), if the participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.",true,"6 Weeks","8 Weeks",{"count":90,"type":22},500,[92],"PHASE3","The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT\u002FTT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent Vaccines at 2,4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-DT\u002FTT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).",[30,95],"Pneumococcal Infections",[97,98,99,100],"PCV13","Hexavalent Vaccine","Prevenar 13","Co-administration","RECRUITING","2025-03-20",{"date":104,"type":45},"2025-03-24",{"date":106,"type":45},"2024-11-01",{"date":108,"type":22},"2026-10-01",{"name":110,"class":111},"Beijing Minhai Biotechnology Co., Ltd","INDUSTRY"]