[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pertussis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pertussis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,55,81,179,209,239,262,288,314],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100638753","phase-4-maternal-immunization-with-tetanus-toxoid-reduced-diphtheria-toxoid-reduced-dose-2-g-recombinant-pertussis-vaccine-tdap2gen-and-its-effect-on-the-immune-response-in-thai-infants-up-to-15-18-months-old-100638753",false,"NCT07621341","Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response in Thai Infants up to 15-18 Months Old","Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response to Tetanus, Diphtheria and Pertussis in Thai Infants up to 15-18 Months Old: An Open-label, Randomized Controlled Trial","M-PRIME","Phase 1: Pregnant women\n\nInclusion Criteria:\n\n* Pregnant women aged 20 to 45 years\n* Healthy women in good general health\n* Gestational age between 20 and 32 weeks at enrollment\n* Singleton pregnancy\n* Low-risk, uncomplicated pregnancy as assessed by an obstetrician\n* No evidence of congenital anomalies identified on prenatal ultrasonographic screening\n* Willing to receive TdaP2gen vaccination and comply with collection of biological specimens as specified in the study protocol\n* Willing to allow their infant to receive either whole-cell pertussis-containing or acellular pertussis-containing combination vaccines according to the study randomization process, and to allow collection of biological specimens from the infant as specified in the study protocol\n* Able and willing to provide written informed consent prior to study participation\n\nExclusion Criteria:\n\n* Receipt of a tetanus-, diphtheria-, and chemical-detoxified pertussis-containing vaccine within 1 year prior to enrollment, or receipt of a tetanus-, diphtheria-, and genetic-detoxified pertussis-containing vaccine (TdaPgen) or genetic-detoxified acellular pertussis vaccine (aPgen) within 2 years prior to enrollment, including during the current pregnancy\n* History of laboratory-confirmed or clinically diagnosed pertussis infection within 1 year prior to enrollment\n* Presence of underlying medical conditions that may affect study outcomes, including but not limited to malignancy, autoimmune disease, immunodeficiency, epilepsy, hypertension, renal disease, or liver disease, as determined by the investigators\n* Pregnancy complications including hypertension (blood pressure \\>140\u002F90 mmHg with proteinuria, or \\>150\u002F100 mmHg regardless of proteinuria), current antihypertensive treatment, or preeclampsia\n* Endocrine disorders including hyperthyroidism, untreated hypothyroidism, or impaired glucose tolerance (e.g., type 1 or type 2 diabetes mellitus) diagnosed before or during pregnancy requiring treatment beyond dietary control\n* Severe or progressive neurological disorders, including epilepsy or a history of Guillain-Barré syndrome\n* Receipt of immunosuppressive agents, immunomodulatory agents, or high-dose systemic corticosteroids (\\>2 mg\u002Fkg\u002Fday, \\>20 mg\u002Fday, or equivalent) for more than 14 consecutive days within 6 months prior to enrollment\n* History of stillbirth, neonatal death, or recurrent spontaneous abortion (≥3 episodes).\n* Current medical or surgical treatment for prevention of preterm labor during the current pregnancy\n* Receipt of blood products, blood components, or immunoglobulins within 6 months prior to enrollment\n* Receipt of live attenuated vaccines within 3 months or any other vaccines within 28 days prior to enrollment\n* History of hypersensitivity or adverse reactions to study vaccines or vaccine components, or history of severe allergic reactions such as anaphylaxis to any vaccine\n* Behavioral, cognitive, or psychiatric conditions that, in the opinion of the investigator, may interfere with study participation or protocol compliance\n* History of smoking, alcohol abuse, or intravenous drug use that, in the opinion of the investigator, may interfere with study assessments or outcomes\n* Fever (body temperature ≥38.0°C or equivalent) within 72 hours prior to enrollment\n* Acute illness within 4 weeks prior to enrollment\n* Contraindications to intramuscular vaccination, including thrombocytopenia, coagulation disorders, hemophilia A or B, or use of anticoagulant therapy during pregnancy\n* Concurrent participation in another clinical study involving investigational vaccines or medications during participation in this study\n* Any medical or obstetric condition that, in the opinion of the study investigator, may interfere with study assessments or increase the risk to the mother or infant associated with study participation\n\nPhase 2: Infants\n\nInclusion Criteria:\n\n\\- All infants born to pregnant women enrolled in Phase 1 who received TdaP2gen vaccination during pregnancy will be eligible for enrollment to Phase 2 study\n\nExclusion Criteria:\n\n* Gestational age \\\u003C32 weeks (very preterm birth)\n* Birth weight \\\u003C1,500 grams (very low birth weight)\n* Presence of major congenital anomalies identified after birth, including congenital abnormalities associated with genetic disorders, congenital infections, or severe structural abnormalities involving major organ systems such as the central nervous system, cardiovascular system, respiratory system, hepatobiliary and gastrointestinal system, or genitourinary system\n* Presence of severe neonatal medical conditions that may affect immune responses to study vaccines, including but not limited to severe respiratory distress, severe bronchopulmonary dysplasia, hypoxic ischemic encephalopathy (HIE), severe intraventricular hemorrhage (IVH), severe sepsis, non-physiologic jaundice, neonatal autoimmune thrombocytopenia, neurological disorders such as neonatal convulsions, necrotizing enterocolitis, or intracranial hemorrhage\n* Presence of conditions associated with increased risk of serious adverse reactions to study vaccines\n* Any medical condition or circumstance that, in the opinion of the study investigator, may interfere with study assessments or increase the risk to the participant associated with study participation",true,"ALL","0 Days","45 Years",{"count":22,"type":23},320,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","Pertussis remains a major global public health problem. In Thailand, pertussis vaccination is recommended during pregnancy at 20-32 weeks' gestation, together with routine childhood diphtheria-tetanus-pertussis vaccination administered as a primary series at 2, 4, and 6 months and booster doses at 18 months and 4-6 years of age.\n\nTdaP2gen, a newly developed combined tetanus, diphtheria, and recombinant genetically detoxified acellular pertussis vaccine containing 2 µg pertussis antigen, has shown favorable safety and non-inferior immunogenicity compared with existing pertussis vaccines. However, data on its use in pregnant women, transplacental antibody transfer, and potential immune interference in infants remain limited.\n\nThis study aims to evaluate the safety and immunogenicity of TdaP2gen in pregnant women, assess antibody transfer to newborns, and investigate immune responses to tetanus, diphtheria, and pertussis following primary and booster pertussis-containing vaccinations in infants and toddlers, including comparisons between whole-cell and acellular pertussis-containing vaccine schedules.",[29,30,31,32],"Pertussis","Diphtheria","Tetanus","Vaccine-Preventable Diseases",[34,35,36,37,38,39,40,41],"Safety","Immunogenicity","Immune interference","Pregnant women","Newborns","Infants and young children","Pertussis-containing vaccine","Genetically-detoxified recombinant acellular pertussis vaccine","NOT_YET_RECRUITING","2026-05-27",{"date":45,"type":46},"2026-06-02","ACTUAL",{"date":48,"type":23},"2026-05-26",{"date":50,"type":23},"2030-12-31",{"name":52,"class":53},"Chiang Mai University","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":17,"sex":18,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":24,"phases":65,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":54},"100625110","phase-1-phase-iii-clinical-trial-of-diphtheria-tetanus-pertussis-reduced-dose-vaccine-100625110","NCT07418372","Phase I\u002FII Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine","A Randomized, Double-Blind, Parallel-Controlled Phase I\u002FII Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above","Inclusion Criteria:\n\n* Age Requirement: volunteers aged 6 years and above\n* Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.\n\nExclusion Criteria:\n\n* Subjects whose physical examination, vital signs check, or laboratory test results are abnormal and have clinical significance, and are determined by the researcher to be unsuitable for participation in the clinical trial.\n* Subjects who have received any vaccine within 30 days (including the 30th day) before enrollment, or those who plan to receive other vaccines within 30 days (including the 30th day) after receiving the investigational vaccine.\n* Subjects who have experienced acute diseases (such as fever) or acute exacerbations of chronic diseases within 3 days before enrollment (including the third day).\n* Subjects who have had contact with patients clearly diagnosed with pertussis, diphtheria or tetanus within 30 days before enrollment.\n* Individuals who have been clinically diagnosed with diphtheria or tetanus within 10 years before enrollment, or with pertussis within 5 years; or those who have experienced paroxysmal spasmodic coughing for at least 14 days without fever within 5 years, and for which no other specific cause (such as influenza) can be identified, and have a history of exposure to pertussis or contact with confirmed cases.\n* Subjects who have been diagnosed with serious diseases that may interfere with the conduct or completion of the trial.\n* Subjects who have shown allergic reactions to any component of the trial vaccine (such as aluminum adjuvant) before enrollment, or have experienced severe allergic reactions, suspected severe allergies (such as Arthus reaction, anaphylactic shock, laryngeal edema, allergic purpura, local allergic necrotic reaction, etc.) or other serious adverse reactions (such as thrombocytopenic purpura, breathing difficulties, angioneurotic edema, widespread rash, brachial plexus neuritis, etc.) to any vaccine or drug before enrollment.\n* Subjects who have experienced convulsions, epilepsy, mental disorders before enrollment, or have a family history of such diseases, or have had severe brain diseases (such as hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumors, cerebral infarction, stroke, etc.) before enrollment.\n* Subjects with coagulation disorders (such as deficiency of coagulation factors, coagulation diseases, and platelet abnormalities), or a history of bleeding disorders, or those with hereditary bleeding tendencies.\n* Individuals with primary or secondary immune function impairment, or those who have been receiving immunosuppressive therapy for a long time (such as long-term systemic glucocorticoid treatment, for example, using prednisone or similar drugs for two weeks or more continuously, but local use such as ointments, eye drops, inhalants or nasal sprays is allowed), or those who plan to use it during the trial.\n* Subjects who have had their spleen removed or undergone partial or complete removal of other vital organs (such as the liver, kidneys, lungs, pancreas, thyroid, stomach, intestines, and other vital organs) due to any cause.\n* Subjects who have donated blood or lost blood (≥ 400 ml) within 6 months before enrollment, received blood transfusion or used blood products, or plan to receive blood transfusion or use blood products during the trial.\n* Any investigational or unregistered products (drugs, biologics or devices) were used within 6 months before enrollment, or the subject plans to participate in or is currently participating in any clinical trial.\n* Subjects who may be unable to follow the trial procedures, abide by the agreement, or plan to permanently relocate from this area during the trial period, or be away from the local area for a long time during the scheduled visits.\n* Subjects deemed by the investigator to be unsuitable for participation in the study.","6 Years",{"count":64,"type":23},660,[66,67],"PHASE1","PHASE2","This is a randomized, double-blinded, parallel-controlled phase I\u002FII clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.",[70,31,30,29,71],"Tetanus, Diphtheria and Acellular Pertussis Vaccination","Pertussis Vaccines","2026-02-11",{"date":74,"type":46},"2026-02-18",{"date":76,"type":23},"2026-03-12",{"date":78,"type":23},"2027-07-31",{"name":80,"class":53},"Institute of Medical Biology, Chinese Academy of Medical Sciences",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":17,"sex":18,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":151,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":54},"100620537","risk-assessment-of-community-spread-of-multiple-endemic-infectious-diseases-in-a-one-health-perspective-100620537","NCT07358910","Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective","RACSMEI","Inclusion Criteria:\n\n* Residency in the village for more than 6 months;\n* Age between 2 and 75 years old at the time of inclusion;\n* For adults: provision of written consent;\n* For children aged 2-17 years: written parental consent form, verbal assent from children aged 13-17 years;\n\nExclusion Criteria:\n\n* Unable to understand or consent;\n* Under guardianship or deprived of liberty;\n* Medical conditions that impede survey participation;\n* Refusal to participate in the study.","2 Years","75 Years",{"count":91,"type":23},10000,"OBSERVATIONAL","RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.\n\nRACSMEI will improve understanding across multiple pathogens using a multidisciplinary One Health approach. We will answer key questions on burden, ecology, transmission and population immune status to inform targeted and culturally appropriate interventions. The project combines a nationally representative One Health survey, social-science methods, and multiplex, diverse diagnostics to efficiently test for 57 priority pathogens, including zoonotic and vector-borne agents, vaccine-preventable and elimination-targeted diseases, enteric, respiratory, and environmentally transmitted pathogens and selected neglected tropical diseases and parasites relevant to Cambodia.\n\nMathematical modelling will reconstruct and forecast transmission dynamics and assess the potential impact of future public-health strategies. By integrating intersectoral data and innovative methods, RACSMEI will generate actionable evidence for public-health authorities, support precision One Health interventions, and help reduce disease burden in affected communities. The project also aims to ensure the transferability of methods and insights to other countries facing similar challenges.",[95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,29,122,31,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"Dengue","Chikungunya","Zika Virus Infection","Japanese Encephalitis","West Nile Virus","Tick-borne Encephalitis (TBE)","Severe Fever With Thrombocytopenia Syndrome","Nipah Virus Infection","Hantavirus Infections","Hepatitis E","Brucellosis","Q Fever","Leptospirosis","Melioidosis","Influenza A and B","Malaria","Yellow Fever","Mayaro Fever","Usutu Virus Infection","Oropouche Fever","Rift Valley Fever","Arenavirus Infections","Measles","Mumps","Rubella","Human Papilloma Virus (HPV)","Rotavirus Disease","Diphteria","Varicella","Hepatitis A","Norovirus Infections","Enterovirus","Adenovirus","Rhinovirus","Parvovirus","Respiratory Syncytial Virus (RSV)","Cytomegalovirus","Epstein Barr Virus","Salmonella Typhi","Vibrio Cholerae","Legionella Pneumophila Pneumonia","Mycoplasma","Chlamydia","Lymphatic Filariasis","Toxoplasma Gondii","Giardiasis","Entamoeba Histolytica","Leishmaniasis","Strongyloides Stercoralis Infection","Ascaris Lumbricoides","Trichuris Trichiura","Clonorchis Sinensis","Opisthorchis Viverrini","Schistosomiasis","Streptococcus Pneumoniae","Meningitis",[152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168],"Infectious disease","One Health","Population-based survey","Nationally representative survey","Seroepidemiology","Multiplex serology","Seroprevalence","Vector-borne diseases","Zoonoses","Vaccine-preventable diseases","Neglected tropical diseases","Transmission dynamics","Force of infection","Mathematical modelling","Spatial epidemiology","Precision public health","Cambodia","RECRUITING","2026-01-14",{"date":172,"type":46},"2026-01-22",{"date":174,"type":46},"2025-12-18",{"date":176,"type":23},"2027-09-30",{"name":178,"class":53},"Institut Pasteur du Cambodge",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":17,"sex":18,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":24,"phases":190,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":54},"100588906","phase-2-a-phase-iiiii-study-to-evaluate-the-immunogenicity-safety-and-lot-to-lot-consistency-of-lbvd-a-fully-liquid-hexavalent-diphtheria-tetanus-whole-cell-pertussis-hepatitis-b-poliovirus-haemophilus-influenzae-type-b-conjugate-dtwp-hepb-ipv-hib-vaccine-in-healthy-infants-as-primary-series-100588906","NCT06947499","A Phase II\u002FIII Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series","A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II\u002FIII Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series","Inclusion Criteria:\n\n* healthy infants from 6 weeks to 8 weeks of age (both inclusive)\n* body weight ≥ 3.2 kg\n* born at full term pregnancy (≥ 37 weeks)\n* signed informed consent by parent(s) or legally acceptable representative(s)\n\nExclusion Criteria:\n\n* Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis\n* Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration\n* Known history of SARS-CoV-2 infection\n* Participant's mother is HepB antigen or HIV positive\n* Fever ≥ 38.0 C\u002F100.4 F within 3 days prior to enrollment\n* Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)\n* Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination\n* Received immunosuppressive agents or other immune-modifying drugs\n* Previous use of blood or blood-derived products\n* Any history of allergy (hypersensitivity) to any of the vaccine components\n* Participation in another interventional clinical trial within 4 weeks of expected first vaccination","6 Weeks","8 Weeks",{"count":189,"type":23},1186,[67,191],"PHASE3","The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants",[30,31,29,194,195,196],"Hepatitis B","Poliomyelitis","Haemophilus Influenzae Type b",[198],"vaccination","2025-06-30",{"date":201,"type":46},"2025-07-03",{"date":203,"type":46},"2025-05-30",{"date":205,"type":23},"2027-04",{"name":207,"class":208},"LG Chem","INDUSTRY",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":24,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100577840","phase-4-10-year-follow-up-after-a-single-dose-acellular-pertussis-vaccination-100577840","NCT06803524","10-year Follow-up After a Single Dose Acellular Pertussis Vaccination","Antibody Persistence and Safety and Immunogenicity of a Second Booster Dose 10 Years After a First Booster Vaccination With a Single Dose Vaccination of aP Vaccine in Adults: A Phase IV, Open-label, Non-randomized, Follow-up Study","Inclusion Criteria:\n\nA participant will be eligible for inclusion if ALL of the following apply at the time of screening:\n\n1. Having participated in the initial TDA202 study, received a single dose of one of the 3 study vaccines, and completed 1-year follow-up visit;\n2. Written informed consent is obtained prior to study entry;\n3. Healthy, as established by pertinent medical history and physical examination;\n4. Capable of complying with study procedures and willing to provide with a blood sample;\n5. For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilisation, hysterectomy or who are post-menopausal), must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for one month following vaccination.\n\nExclusion Criteria:\n\nA participant with following criteria at screening will not be eligible for participation:\n\n1. Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;\n2. Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;\n3. Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;\n4. History of any significant medical illness such as, but not limited to, immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, or endocrine disorder, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participant's safety and evaluation of investigational vaccines in this study;\n5. History of allergy or hypersensitivity to any vaccine (including its component);\n6. History of any serious adverse event or neurological adverse event after vaccination;\n7. History of receiving blood or blood component or immunoglobulin within 3 months prior to enrollment;\n8. History of receiving immunosuppressive drugs or systemic corticosteroid (\\>0.5 mg\u002Fkg of prednisolone or equivalent for more than 14 days) within 3 months prior to enrollment;\n9. Having received any other vaccines within 28 days prior to enrollment (3 months for live- attenuated vaccines);\n10. Plan to receive any other vaccine or plan to participate in another clinical trial with intervention during the study period;\n11. A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection;\n12. Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barré syndrome;\n13. History of any illness or clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the volunteers due to participation in the study\n14. Fever as defined by body temperature ≥ 38°C at the time of enrollment (This is a temporary exclusion criterion).\n\nRemark: If fever occurs at screening visit, the participant may be rescreened and enrolled at a later date at the discretion of the investigator, or withdrawn at the discretion of the investigator.",{"count":217,"type":23},126,[26],"This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II\u002FIII trial (Protocol No. TDA202).",[29],[222,223,224,225,226,227,228],"TDA202","acellular pertussis vaccine","a second booster dose of Pertagen® as compared to Adacel®","antibody persistence at 10 years after vaccination","Pertagen","Boostagen","aP vaccine","2025-06-09",{"date":231,"type":46},"2025-06-11",{"date":233,"type":46},"2025-05-13",{"date":235,"type":23},"2026-03",{"name":237,"class":53},"Mahidol University",2,{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":17,"sex":18,"minAge":246,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":24,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100563594","phase-2-study-to-evaluate-the-immunogenicity-of-lr20062-compared-to-control-when-administered-intramuscularly-in-healthy-infants-at-2-4-6-months-of-age-100563594","NCT06618196","Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age","A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age","Inclusion Criteria:\n\n1. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.\n2. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.\n2. Has a known SARS-CoV-2 infection at Screening.\n3. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.\n4. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.\n5. Had a recent febrile illness, defined as axillary temperature ≥38.0℃ \\[≥100.4℉\\] occurring at or within 72 hours prior to receipt of study vaccine.\n\n   Prior\u002Fconcomitant therapy:\n6. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and\u002For Hib infections since birth.\n7. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.\n8. Meets one or more of the following systemic corticosteroid exclusion criteria:\n\n   1. Has received systemic corticosteroids (equivalent of ≥0.5 mg\u002Fkg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.\n   2. Is expected to require any systemic corticosteroids during conduct of the study.\n\n   Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.\n9. Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.\n\nException: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.","50 Days","70 Days",{"count":249,"type":23},336,[67],"This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.",[30,31,29,194,195,253],"Haemophilus Influenzae Type B Infection","2024-09-26",{"date":256,"type":46},"2024-10-01",{"date":258,"type":23},"2024-10-02",{"date":260,"type":23},"2026-04-30",{"name":207,"class":208},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":17,"sex":18,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":24,"phases":273,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":54},"100562637","safety-and-immunogenicity-of-dtap-ipvhib-pentavalent-vaccine-in-chinese-2-month-old-infants-100562637","NCT06605755","Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants","Extended Study on the Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants: a Randomized, Prospective, Open Clinical Study","Inclusion Criteria:\n\n\\- (1)Received 4 doses of DTaP-IPV\u002FHib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form\n\nExclusion Criteria:\n\n-(1) Diagnosed by a physician with a coagulation abnormality (e.g., coagulation factor deficiency, coagulopathy, platelet abnormality) (2) Any other factor considered to make participation in the trial unsuitable.","19 Months","22 Months",{"count":272,"type":23},785,[274],"NA","The main purpose of this study is to evaluate immune persistence at 30 and 36 Months of Age and Pertussis Breakthrough Infections between 19 and 36 Months of Age following two regiments of DTaP-IPV\u002FHib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China.",[29,30,31,253,277],"Polio","2024-09-18",{"date":280,"type":46},"2024-09-20",{"date":282,"type":46},"2024-09-05",{"date":284,"type":23},"2026-02",{"name":286,"class":287},"Jiangsu Province Centers for Disease Control and Prevention","NETWORK",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":18,"minAge":295,"maxAge":296,"enrollmentInfo":297,"targetDuration":88,"studyType":92,"phases":4,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":54},"100538067","prevalence-and-impact-of-pertussis-and-rsv-on-asthma-severity-and-control-100538067","NCT06286007","Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control","PRIPASCO","Inclusion Criteria:\n\n* Adult patient (age 18 years and over)\n* Diagnosed with asthma at least one year prior to the date of enrolment.\n* Patients who, in the opinion of the investigator, can and will comply with the requirements of the study protocol for the duration of the follow-up period (e.g. agree to provide samples for testing, able to attend for testing upon asthma exacerbation and\u002For ARI symptoms occurring)\n* Patients who are able to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with a prior history of pertussis in the last 12 months\n* Patients with ARI within the 2 weeks prior to enrolment\n* Patients who have another respiratory disease other than asthma, alcohol or drug abuse at the time of being included in the study, or an active oncological disease (patients in treatment or follow-up for oncological disease) or pregnant women.\n* Patients treated with immunosuppressive or immunomodulating agents not related to asthma diagnosis. will be excluded.\n* Patients vaccinated for RSV will be also excluded (NOTE: -Patients that have received an RSV (investigational) vaccine or medicine for any of the above, should be excluded from the study from the beginning. Patients that might be vaccinated in the upcoming years, while the study is still ongoing, can enrol. However, from the moment they receive a vaccine, they should be excluded and no additional data will be collected. Data collected during the study up until the time of vaccination will still be included in the analysis).\n* Patients vaccinated for B. Pertussis during the previous 12 months will be also excluded.\n* Patients who plan to move during the study period will be excluded.","18 Years","99 Years",{"count":298,"type":23},784,"The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).\n\nA multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.\n\nParticipants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up",[301,29,302],"Asthma","RSV Infection",[301,29,302,304],"Exacerbations","2024-02-29",{"date":307,"type":46},"2024-03-01",{"date":309,"type":46},"2023-12-21",{"date":311,"type":23},"2026-07-01",{"name":313,"class":53},"Hospital Clinico Universitario de Santiago",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":17,"sex":18,"minAge":321,"maxAge":62,"enrollmentInfo":322,"targetDuration":4,"studyType":24,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":335},"100530266","phase-1-phase-i-clinical-trial-of-diphtheria-tetanus-acellular-pertussis-component-combined-vaccine-100530266","NCT06184542","Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine","To Evaluate Safety and Preliminary Immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children Aged 2 Months to 6 Years: A Randomized, Blinded, Active-controlled Phase I Clinical Trial","Inclusion Criteria:\n\n* Age Requirement: children aged 6 years, toddlers aged 18-24 months, and infants aged 2-3 months at the time of enrollment\n* Previous Vaccination Requirements: (a) Children (aged 6 years) enrolled in the study should have received four doses of the Diphtheria, Tetanus, and Pertussis combined vaccine, and not yet received the Diphtheria, Tetanus combined vaccine; (b) Toddlers (aged 18-24 months) enrolled in the study should have received three doses of Diphtheria, Tetanus, and Pertussis combined vaccine as well as three doses of the Polio vaccine, and not yet received the booster dose of Diphtheria, Tetanus, and Pertussis combined vaccine and the Polio vaccine; (c) Infants (aged 3 months) enrolled in the study should not have received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, Haemophilus influenzae type b conjugate vaccine, or meningococcal group A and C polysaccharide conjugate vaccine; (d) Infants (aged 2 months) enrolled in the study should not received diphtheria-tetanus-pertussis-containing vaccine, polio-containing vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine, or Haemophilus influenzae type b conjugate vaccine.\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Birth Outcome Condition: Toddlers (aged 18-24 months) and Infants (aged 2-3 months) should be born at full term (37-42 weeks of gestation) with birth weight ≥2500g.\n* Temperature Requirement: Axillary body temperature is no more than 37.3°C.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be not eligible for enrollment.\n\n* Previous Diagnosis: Subjects diagnosed with pertussis, tetanus, or diphtheria disease.\n* Special Conditions for Toddlers (aged 18-24 months) and Infants (aged 2-3 months): Subjects have been with abnormal labor (dystocia, instrumental delivery) or a history of asphyxia, nervous system damage, or clinically confirmed pathological jaundice.\n* Allergic History: Subjects have a history of allergies to any component of the vaccine (such as aluminum hydroxide), or previous allergy or suspected allergy to any vaccine, or other serious adverse reactions, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and\u002For urticaria.\n* Vaccination History: Subjects received any inactivated vaccines or subunit vaccines within 7 days before vaccination (except COVID-19 vaccines) with the investigational vaccine, or any other live attenuated vaccines or COVID-19 vaccines within 14 days before vaccination\n* Acute Illness: Subjects have acute illness (e.g., fever) or acute exacerbation of a chronic illness within 3 days before receipt of the first dose of the investigational vaccine\n* Neurological and Mental Health: Subjects have a history or family history of seizures, epilepsy, and other encephalopathy and psychiatric disorders.\n* Health Condition: Subjects have a major congenital malformation, developmental disability, or congenital disease (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders), or other clinically diagnosed serious chronic disease, including but not limited to, serious diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic system, skeletal system and other system and malignant tumor history.\n* Blood Disease: Subjects have genetic bleeding tendency or coagulopathy, or a history of bleeding disorders.\n* Infectious Disease: Subjects diagnosed with infectious diseases that may interfere with the study, such as tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc.\n* Special Condition: Subjects who cannot tolerate venipuncture or have a history of needle and blood sickness.\n* Organ Removal History: Subjects with surgical removal of the spleen or other vital organs for any reason.\n* Blood Condition: Subjects with blood loss (≥400 ml) and receipt of blood or blood products in the 3 months before receipt of the first dose of the investigational vaccine\n* Immune Therapy: Subjects received treatment with an immunosuppressive agent, such as long-term systemic glucocorticoid therapy (treatment with systemic glucocorticoids, such as prednisone or a similar agent, for more than 2 consecutive weeks within 6 months before receipt of the first dose of an investigational vaccine), except topical agents (such as ointments, eye drops, inhalers, or nasal sprays) that do not exceed the recommended dose in the label or have any signs of systemic exposure\n* Participation in Other Clinical Studies: Subjects use any investigational or unregistered product (drug, biologic product, or device) within 3 months before receipt of the first dose of the investigational vaccine, plan to use such product during the duration of this study, or were enrolled in another clinical trial before enrollment in this study.\n* Physical Examination: (a) Subjects with abnormal vital signs with clinical significance; (b) Subjects abnormal blood routine, blood biochemistry, and urine routine test indicators with clinical significance\n* Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.\n\nContraindications of the second and third doses of the vaccine:\n\nSubjects meeting any of the following contraindications will be not eligible for the following doses.\n\n* Serious Adverse Events: Subjects experienced serious adverse events related to vaccination after the previous dose.\n* Vaccination with other vaccines during the study: (a) Subjects received other diphtheria, Tetanus, and acellular pertussis combined vaccines except for the investigational vaccine after the previous dose during the study period; (b) Infants (C3 subgroup and D3 subgroup) received other polio vaccines after the previous dose during the study period.\n* Ineligibility: Subjects cannot be eligible or meet exclusion criteria after the previous dose of the investigational vaccine, and the qualification should be determined by the investigator.\n* Investigator's Discretion: Subjects determined by the investigator as unsuitable for the following study period.","2 Months",{"count":323,"type":23},460,[66],"This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.",[30,31,29],"2024-01-01",{"date":329,"type":46},"2024-01-03",{"date":331,"type":46},"2023-12-23",{"date":333,"type":23},"2026-11-01",{"name":80,"class":53},3]