[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumococcal-infectious-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumococcal-infectious-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,64,88],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100577589","phase-1-clinical-trial-of-pcv24-in-infants-aged-2-23-months-100577589",false,"NCT06800261","Clinical Trial of PCV24 in Infants Aged 2-23 Months","A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months","Inclusion Criteria:\n\n1. Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;\n2. Participants' guardian provides legal identity document and participants' vaccination record;\n3. Participants' guardian understands and voluntarily signs the informed consent form;\n4. Follow all study procedures and stay in contact during the study.\n\nExclusion Criteria:\n\n1. Received any pneumococcal vaccine prior to enrollment;\n2. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;\n3. History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;\n4. Low birth weight (\\\u003C2.5kg), or premature infant (gestation weeks \\\u003C 37 weeks) (applies to infants younger than 12 months);\n5. History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);\n6. Congenital malformations or developmental disorders, genetic defects, severe malnutrition;\n7. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;\n8. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);\n9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture).\n10. Have\u002Fhave suffered from a serious neurological disorder (epilepsy or convulsions, but febrile convulsion is not an exclusion criteria ) or mental illness or have a family history of such diseases.\n11. Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study.\n12. Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.\n13. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;\n14. Received live attenuated vaccine within 14 days prior to enrollment;\n15. Received subunit or inactivated vaccine within 7 days prior to enrollment;\n16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;\n17. Axillary temperature≥ 37.3 Degree Celsius before vaccination;\n18. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.",true,"ALL","42 Days","23 Months",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.\n\nThe objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase Ib clinical trial.",[28],"Pneumococcal Infectious Disease","RECRUITING","2026-01-26",{"date":32,"type":33},"2026-01-28","ACTUAL",{"date":35,"type":33},"2025-05-08",{"date":37,"type":22},"2026-06",{"name":39,"class":40},"Sinovac Life Sciences Co., Ltd.","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100563557","phase-3-clinical-trial-of-13-valent-pneumococcal-conjugate-vaccine-100563557","NCT06617715","Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine","A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants","Inclusion Criteria:\n\n1. Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday);\n2. Participants' guardians provide legal identity document and participants' vaccination record;\n3. Participants' guardians understand and voluntarily sign the informed consent form;\n4. Participants' guardians can follow all study procedures and stay in contact during the study.\n\nExclusion Criteria:\n\n1. Received any pneumococcal vaccine prior to enrollment;\n2. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;\n3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;\n4. History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;\n5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;\n6. Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);\n7. Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours.\n8. Have\u002Fhave suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.\n9. History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons;\n10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.\n11. Consecutively received ≥14 days of corticosteroid, any other immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapy prior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior to enrollment for children aged 7 months to 5 years.\n12. Received blood products prior to enrollment for children aged 2 months or within 3 months prior to enrollment for children aged 7 months to 5 years. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.\n13. Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs during the study;\n14. Received live attenuated vaccine within 14 days prior to enrollment;\n15. Received subunit or inactivated or other vaccine within 7 days prior to enrollment;\n16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment;\n17. Had fever (axillary temperature≥ 37.3 Degree Celsius) before vaccination;\n18. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.","6 Weeks","5 Years",{"count":52,"type":22},3080,[54],"PHASE3","A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.",[28],{"date":32,"type":33},{"date":59,"type":33},"2024-10-23",{"date":61,"type":22},"2026-07-30",{"name":39,"class":40},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100618571","phase-2-pcv24-clinical-trial-in-infants-and-young-children-aged-2-months-minimum-6-weeks-to-71-months-100618571","NCT07333352","PCV24 Clinical Trial in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months","Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of A 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) in Infants and Young Children Aged 2 Months (Minimum 6 Weeks) to 71 Months","Inclusion Criteria:\n\n* Healthy subjects aged 2 months (minimum 6 weeks) and 7-71 months, whose guardians can provide valid identification documents for both the subjects and themselves, as well as proof of their guardianship relationship.\n* The guardians of the subjects voluntarily agree to their participation in this trial, sign the Informed Consent Form (ICF), and are willing to comply with all requirements of this clinical trial protocol.\n* The guardians of the subjects have the ability to understand the trial procedures (non-illiterate).\n\nExclusion Criteria:\n\n* Subjects who have received any type of pneumococcal vaccine prior to enrollment, plan to receive a pneumococcal vaccine during the trial, or have a history of invasive diseases caused by Streptococcus pneumoniae (confirmed by any clinical, serological, or microbiological method).\n* Subjects with abnormal physical examination results that are deemed clinically significant by a clinician.\n* Subjects with suspected or confirmed fever (axillary temperature ≥ 37.5℃) within 3 days prior to enrollment; or those with an axillary temperature ≥ 37.5℃ on the day before the first dose of vaccination.\n* Subjects with a history of acute illness, acute exacerbation of chronic illness, systemic use of antibiotics or antiviral drugs within 3 days prior to the first dose of vaccination; or those who have taken antipyretic, analgesic, or antiallergic drugs (e.g., acetaminophen, ibuprofen, loratadine, cetirizine, etc.) within 3 days prior to the first dose of vaccination.\n* Subjects with a history of allergy to any component of the study vaccine, any vaccine containing tetanus toxoid, or a previous history of severe allergy to any vaccine or drug (including but not limited to anaphylactic shock, allergic laryngeal edema, allergic purpura, immune thrombocytopenic purpura, local allergic necrotizing reaction, dyspnea, angioedema, etc.); or a previous history of the aforementioned severe adverse reactions following the use of any vaccine or drug.\n* Subjects who have received inactivated vaccines, subunit vaccines, or recombinant vaccines within 7 days prior to enrollment; or live attenuated vaccines, adenovirus vector vaccines, etc., within 14 days prior to enrollment.\n* Subjects who have received any other investigational drugs within 3 months prior to enrollment or plan to use them during the trial; those who have received whole blood, plasma, or blood products (e.g., immunoglobulin therapy) within 3 months prior to enrollment or plan to receive such treatments during the trial.\n* Subjects with a history of thrombocytopenia, idiopathic thrombocytopenic purpura, or other coagulation disorders diagnosed by a hospital; or a history of receiving anticoagulant therapy.\n* Subjects with a known current or past history of infectious diseases diagnosed by a hospital, such as active tuberculosis, hepatitis B, hepatitis C, HIV infection, etc.\n* Subjects with known or suspected severe chronic diseases (e.g., liver and kidney diseases, malignant tumors, infectious or allergic skin diseases, hemolytic uremic syndrome); or those whose condition is in the progressive stage and cannot be stably controlled.\n* Infants aged 2 months (minimum 6 weeks) and 7-11 months with abnormal birth weight (\\\u003C2500g), abnormal gestational age (\\\u003C37 weeks or \\>42 weeks), abnormal delivery (dystocia, instrumental delivery), or a history of asphyxia or neuroorganic damage.\n* Infants aged 2 months (minimum 6 weeks) and 7-11 months with severe eczema or severe jaundice (grade 3 or above).\n* Subjects with severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, or severe chronic diseases (e.g., tetralogy of Fallot, tricuspid atresia, Down syndrome, sickle cell anemia, etc.).\n* Subjects with neurological diseases or neurodevelopmental disorders (e.g., febrile convulsions, epilepsy, encephalopathy, focal neurological deficits, encephalomyelitis or transverse myelitis, Guillain-Barré syndrome); or a history of mental illness in the subjects themselves or their biological parents.\n* Subjects with a history of congenital or acquired immunodeficiency, immunosuppression, or autoimmune diseases; or those who have received immunomodulatory therapy within 6 months (e.g., immunosuppressive doses of glucocorticoids \\[dosage reference: equivalent to prednisone ≥0.5mg\u002Fkg\u002Fday for more than 2 weeks\\], monoclonal antibodies, thymopeptides, interferons, etc.); or plan to receive such treatments from enrollment to 30 days after the last dose of vaccination. Topical medications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted.\n* Subjects with asplenia, functional asplenia, or asplenia\u002Fresplenectomy caused by any condition.\n* Subjects whose guardians may be unable to comply with trial procedures, adhere to agreements, plan to permanently relocate from the region before the trial is completed, or be away from the local area for a long time during scheduled visits.\n* Researchers believe that the subject has any other factors that make them unsuitable for participating in the clinical trial, such that continued participation cannot ensure the subject's maximum benefit.","71 Months",{"count":73,"type":22},480,[75],"PHASE2","The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months. The purpose of this study is to evaluate the immunogenicity and safety of the 24-valent pneumococcal polysaccharide conjugate vaccine.",[28],"2026-01-14",{"date":80,"type":33},"2026-01-16",{"date":82,"type":33},"2025-09-11",{"date":84,"type":22},"2027-08",{"name":86,"class":40},"Shanghai Reinovax Biologics Co.,LTD",7,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100616056","phase-2-clinical-trial-of-pcv24-in-infants-and-children-aged-2-months-to-5-years-100616056","NCT07300644","Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years","A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 Months (Minimum 42 Days) to 5 Years","Inclusion Criteria:\n\n1. Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months, and 2-5 years;\n2. The participants' guardian provides a legal identity document and the participants' vaccination record;\n3. The participant's guardian understands and voluntarily signs the informed consent form;\n4. Follow all study procedures and stay in contact during the study.\n\nExclusion Criteria:\n\n1. Received any pneumococcal vaccine prior to enrollment;\n2. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;\n3. History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;\n4. Low birth weight (\\\u003C2.5kg), or premature infant (gestation weeks \\\u003C 37 weeks) (applies to infants younger than 12 months);\n5. History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);\n6. Severe congenital malformations or developmental disorders, genetic defects, or malnutrition;\n7. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;\n8. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);\n9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelet levels);\n10. Have\u002Fhave suffered from a serious neurological disorder (epilepsy or convulsions, but a febrile convulsion is not an exclusion criteria ) or mental illness, or have a family history of such diseases;\n11. Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study;\n12. Receipt of immunoglobulins or other blood products within 3 months prior to administration of the investigational vaccine (except for hepatitis B immunoglobulin or rabies immunoglobulin used within 1 month), or planned use of such products during the study period;\n13. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;\n14. Received live attenuated vaccine within 14 days prior to enrollment;\n15. Received subunit or inactivated vaccine within 7 days prior to enrollment;\n16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;\n17. Axillary temperature≥ 37.3 Degree Celsius before vaccination;\n18. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.",{"count":96,"type":22},420,[75],"A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years.\n\nThe objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase 2 clinical trial.",[28],[101,102],"PCV24","Phase 2","2025-12-17",{"date":105,"type":33},"2025-12-24",{"date":107,"type":33},"2025-11-25",{"date":109,"type":22},"2027-12",{"name":39,"class":40},3]