[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumococcal-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumococcal-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,65,87,113,150,176,208],{"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},"100641422","phase-3-study-to-learn-about-safety-tolerability-and-immune-response-of-a-catch-up-pneumococcal-vaccine-in-children-and-adolescents-100641422",false,"NCT07660198","Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents","A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS","Inclusion Criteria:\n\nCohort 1 (Participants ≥15 Months to \\\u003C2 Years of Age) Healthy toddlers and children ≥15 months to \\\u003C2 years of age with documentation of prior receipt of PCV.\n\nCohort 2 (Participants ≥2 Years to \\\u003C5 Years of Age) Healthy toddlers and children ≥2 years to \\\u003C5 years of age with documentation of prior receipt of PCV if applicable.\n\nCohort 3 (Participants ≥5 Years to \\\u003C18 Years of Age) Healthy children ≥5 years to \\\u003C18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.\n\nExclusion Criteria:\n\nAll Cohorts (Participants ≥15 Months to \\\u003C18 Years of Age)\n\nChildren with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial",true,"ALL","15 Months","17 Years",{"count":21,"type":22},1200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).\n\nThis study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae\n\nThis study is seeking participants who:\n\n* Are children aged 15 months to 18 years.\n* May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.\n\nThe study will be conducted in the United States, Puerto Rico, and other countries.\n\nParticipants will be assigned to 1 of 3 groups based on age:\n\nGroup 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)\n\nWithin each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.\n\nEach participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).\n\nAt the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.",[28],"Pneumococcal Disease","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-24","ACTUAL",{"date":35,"type":33},"2026-06-15",{"date":37,"type":22},"2027-12-02",{"name":39,"class":40},"Pfizer","INDUSTRY",44,{"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":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100638699","phase-3-a-study-to-learn-about-how-a-new-pneumococcal-vaccine-works-in-infants-100638699","NCT07629440","A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.","A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS","Inclusion Criteria:\n\n* infants who are 2 months of age in Group 1.\n* infants who are 2 to 6 months of age in Groups 2 and 3.\n* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.\n\nExclusion Criteria:\n\n* History of severe adverse reaction associated with a vaccine and\u002For severe allergic reaction (eg, anaphylaxis).\n* Major known congenital malformation or serious chronic disorder.\n* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.\n* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.","42 Days","211 Days",{"count":52,"type":22},3230,[25],"The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).\n\nThis study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines.\n\nTo measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.\n\nThere are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are:\n\n* infants who are 2 months of age in Group 1;\n* infants who are 2 to 6 months of age in Groups 2 and 3; and\n* said to be healthy by the study doctor\n\nAbout 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.\n\nAbout 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.\n\nAbout 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age.\n\nInfants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)\u002Flegal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Infants will have 3 blood samples collected.",[28],"2026-06-04",{"date":58,"type":33},"2026-06-05",{"date":60,"type":33},"2026-05-29",{"date":62,"type":22},"2029-06-05",{"name":39,"class":40},73,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100637036","phase-3-a-study-to-learn-about-the-safety-of-an-expanded-pneumococcal-vaccine-in-healthy-infants-100637036","NCT07573462","A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants","A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS","Inclusion Criteria:\n\n* Infants who are about 2 months of age\n* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.\n\nExclusion Criteria:\n\n* History of severe adverse reaction associated with a vaccine and\u002For severe allergic reaction (eg, anaphylaxis).\n* Major known congenital malformation or serious chronic disorder.\n* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.\n* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.","98 Days",{"count":74,"type":22},2400,[25],"The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).\n\nThis study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.\n\nThere are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are:\n\n\\- infants who are about 2 months of age\n\nAbout 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.\n\nInfants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)\u002Flegal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.",[28],"2026-05-26",{"date":80,"type":33},"2026-05-27",{"date":82,"type":33},"2026-05-04",{"date":84,"type":22},"2028-12-30",{"name":39,"class":40},9,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":16,"sex":17,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100603356","phase-4-induction-of-cross-protective-antibodies-for-serogroup-33-by-pneumococcal-conjugate-vaccines-100603356","NCT07135453","Induction of Cross-protective Antibodies for Serogroup 33 by Pneumococcal Conjugate Vaccines","Novel Serotype Alert: Investigate New Pneumococcal Conjugate Vaccines for Inducing Cross-protection Against Newly Discovered Serotype 33E and Putative Novel Serogroup 33 Serotypes","Group 33\u002FPCVs","Inclusion Criteria:\n\n* Healthy adult\n\nExclusion Criteria:\n\n* No prior history of pneumococcal vaccination\n* No immunosuppressing medications or chronic diseases that affect immune function","18 Years",{"count":97,"type":22},70,[99],"PHASE4","The goal of this study is to learn whether different types of vaccines to prevent bacterial infections are able to effectively create antibodies that defend against certain types of bacteria.\n\nWe will give two different types of vaccine and evaluate the effectiveness of antibodies produced by each vaccine in killing bacteria.",[102,28],"Vaccine",{"date":104,"type":33},"2026-05-05",{"date":106,"type":22},"2026-05",{"date":108,"type":22},"2027-08",{"name":110,"class":111},"University of Alabama at Birmingham","OTHER",1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":132,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":112},"100578909","phase-4-opportunistic-pneumococcal-immunisation-trial-in-malnutrition-100578909","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.","6 Months","59 Months",{"count":124,"type":22},214,[99],"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.",[128,28,129,130,131],"Severe Acute Malnutrition in Childhood","Pneumococcal Vaccines","Pneumococcal Infection","Pneumonia in Children",[133,134,135,136,137,138,139],"Pneumococcal","Severe Acute Malnutrition in childhood","Pneumococcal vaccine","Pneumosil","Pneumococcal disease","Pneumococcal infection","Pneumonia","NOT_YET_RECRUITING","2025-12-10",{"date":143,"type":33},"2025-12-18",{"date":145,"type":22},"2026-01",{"date":147,"type":22},"2029-02",{"name":149,"class":111},"Nick Fancourt",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":16,"sex":17,"minAge":95,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":112},"100608725","phase-1-serum-collection-study-for-assay-development-100608725","NCT07205289","Serum Collection Study for Assay Development","A Phase 1B Open-label Study to Collect Serum Following Vaccination With Killed Whole-cell Pneumococcal Vaccine (Gamma-PN) in Adults for Use in Assay Validation","Inclusion Criteria:\n\n* good general health\n\nExclusion Criteria:\n\n* no previous pneumococcal vaccine","69 Years",{"count":159,"type":22},12,[161],"PHASE1","The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation",[164,28],"Pneumococcal Disease, Invasive",[166],"Vaccination pneumococcal","2025-09-25",{"date":169,"type":33},"2025-10-03",{"date":171,"type":22},"2025-10",{"date":173,"type":22},"2026-06",{"name":175,"class":40},"GPN Vaccines",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":16,"sex":17,"minAge":95,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100572292","phase-4-carriage-to-assess-protection-of-new-pneumococcal-vaccines---pcv15-100572292","NCT06731374","Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15","A Phase IV, Experimental Human Pneumococcal Challenge (EHPC) Model to Investigate Streptococcus Pneumoniae Serotype 3 (SPN3) Colonisation Following PCV15, a Double Blind Randomised Controlled Trial (DBRCT) in Healthy Participants Aged 18 - 50 Years in the UK.","RATIONALE-15","Inclusion Criteria:\n\n1. Adults between 18 to 50 years old (inclusive) at the time of enrolment.\n2. Medically healthy, such that according to investigator judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through to the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions may be allowable.\n3. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement.\n4. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diary after inoculation.\n5. Willing and able to give informed consent for participation in the study.\n6. Willing to allow confirmation of past medical history either through provision of, or access to, a medical record summary or other medical documentation or allowing investigators to obtain a copy of their medical history from their GP practice or accessed via electronic patient records.\n7. Willing to allow their GP and\u002For consultant, if appropriate, to be notified of participation in the study.\n8. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS).\n9. For participants of childbearing potential only: willing to use effective contraception for the duration of the study AND to have a pregnancy test on the day of screening and challenge.\n\nExclusion Criteria:\n\n1. Research Participants:\n\n   1. Participation in another research study, in which procedures performed could compromise the integrity of this study (such as significant volumes of blood taken), or are planning to do so within the trial period\n   2. Currently a participant in a previous EHPC trial within the last 2 years or at the discretion of the study team\n2. Vaccination (self-reported or confirmed from GP questionnaire or medical records\u002Fsummary if deemed necessary at clinician discretion):\n\n   1. Have had any previous pneumococcal vaccination in the past 5 years (including in a research study)\n   2. Planned vaccination during the study\n3. Allergy:\n\n   1. Have an allergy to penicillin or amoxicillin (for main study cohort only)\n   2. History of a bleeding disorder (e.g., Factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture\n   3. Have previous anaphylaxis or severe adverse reaction to any component\u002Fexcipient of the vaccine or to any vaccine\n   4. Allergy to Lidocaine local anaesthetic (for nasal biopsy cohort only)\n4. Health History (self-reported or confirmed from GP questionnaire or medical records\u002Fsummary if deemed necessary): moderate ill health including but not limited to:\n\n   1. Asplenia or dysfuction of the spleen\n   2. Chronic respiratory disease (e.g. asthma \\[on medication\\], COPD, emphysema, bronchiectasis)\n   3. Chronic heart disease (e.g. angina, ischaemic heart disease, chronic heart failure) \\[controlled stable hypertension +\u002F- angina may be included\\].\n   4. Chronic kidney disease (e.g. nephrotic syndrome, kidney transplant, on dialysis)\n   5. Chronic liver disease (e.g. cirrhosis, biliary atresia, hepatitis)\n   6. Chronic neurological conditions\n   7. Connective tissue disease\n   8. Dementia\n   9. Diabetes mellitus (including diet controlled)\n   10. Immunosuppression or history of receiving immunosuppressive therapy - at the discretion of the investigator\n   11. Individuals with cochlear implants\n   12. Individuals with major cerebrospinal fluid leaks (e.g. following trauma, major skull surgery, or requiring CSF shunt)\n   13. Recurrent otitis media.\n   14. History of significant unexplained bleeding after a surgical or dental procedure (for nasal biopsy participants only)\n   15. Have any uncontrolled medical\u002Fsurgical\u002Fmental health conditions at the discretion of the study doctor.\n   16. Major pneumococcal illness requiring hospitalisation within the last 10 years.\n   17. Significant mental health condition (e.g previous admissions in a psychiatric unit, at the discretion of the clinician) that would impair the participant's ability to participate in the study\n5. Taking Medications:\n\n   1. Any medication that may affect the immune system in the last 3 months (e.g. systemic steroids \\[IM\u002FIV\\], Roaccutane, disease modifying anti-rheumatoid drugs)\n   2. Long-term use of antibiotics (see also section of Temporary Exclusion Criteria)\n   3. Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 1 month\n   4. Use of any medication affecting blood clotting (any oral\u002Finjectable anticoagulants)\n6. Female participants who are pregnant, lactating or intending on becoming pregnant during the study\n7. Direct caring role or close contact with individuals at higher risk of infection (for main study cohort only):\n\n   1. Children under 5 years of age\n   2. Chronic ill health or immunosuppressed adults\n   3. Older adults\n8. Smoker:\n\n   1. Current or ex-smoker (regular cigarettes\u002Fcigars\u002Fe-cigarette\u002Fvaping\u002Fsmoking of recreational drugs) in the last 6 months\n   2. Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent \\[\\>20 pack years\\])\n9. Suspected or known current alcohol or drug abuse, as per investigators discretion\n10. Overseas travel during the follow-up period (from the time point of inoculation to antibiotic treatment or completion of the 28 day follow up period post inoculation)\n11. Any other issue which, in the opinion of the study staff, may:\n\n    1. Put the participant or their contacts at risk because of participation in the study\n    2. Adversely affect the interpretation of the study results, or\n    3. Impair the participant's ability to participate in the study\n12. Study site staff or a partner or dependent child of study site staff","50 Years",{"count":186,"type":22},106,[99],"Streptococcus pneumoniae (pneumococcus) is a bacterium that causes just under four million serious infections every year. It is normal for pneumococcus bacteria to live in the noses of healthy adults and children as part of the nasal microflora without causing harm. This is called \"carriage\". But the bacteria can still be passed on to other people. If they are at-risk, for example elderly, or very young, or have pre-existing health conditions, the pneumococcus bacteria can cause pneumonia, which can cause serious life-threatening illness.\n\nPneumococcus bacteria are surrounded by a sugar capsule. But the capsule does not always have the same components. As a result, the bacteria are classified into more than 100 different types. To make them effective, the vaccines that are currently available contain the sugar capsules of the most common pneumococcal types that cause disease.\n\nOne such vaccine - PCV13 - has been effective globally in protecting against pneumococcus disease. It works because it controls the \"carriage\" (how a person carries the bacteria in their nose) of 13 types of the bacteria. Vaccines giving protection against other types of the bacteria are also becoming available worldwide. PCV15 is similar to PCV13 and protects against two additional types of the bacteria so may offer more protection.\n\nThis study, which lasts 2 months and is funded by Merck Sharp \\& Dohme (MSD), aims to assess if using PCV15 can protect against \"carriage\". To do this, investigators will use a well-established method already used with more than 2,000 people safely in other research. This involves \"challenging\" volunteers by putting a small amount of the pneumococcus bacteria into their noses. In this study, before they are challenged, volunteers will either be vaccinated with the real PCV15 vaccine or a dummy (\"placebo\"). The Investigators will then be able to compare the two groups to find out who the vaccine protected and who it did not.\n\nAfter the study everyone who takes part and fit into certain criteria will be given antibiotics to clear the pneumococcus colonisation. They will also be regularly monitored during the study to ensure their safety.\n\nA very small number of volunteers will be asked to have a biopsy to collect tissue samples from inside their nose before and after being vaccinated with PCV15. This will help researchers to understand more about how the immune system responds to the vaccine.\n\nThe information gain in this project will help the investigators to understand how exactly PCV15 vaccine protects people against pneumococcus. This means that this vaccine and future pneumococcal vaccines will be improved to protect many lives in future around the world.",[28,190],"Pneumococcal Carriage",[192,193,194,195,196,197],"Streptococcus pneumoniae","Experimental Human Pneumococcal Challenge","Pneumococcal carriage","PCV15","VAXNEUVANCE","SPN3","2025-04-11",{"date":200,"type":33},"2025-04-15",{"date":202,"type":33},"2025-02-24",{"date":204,"type":22},"2026-12",{"name":206,"class":111},"University of Oxford",2,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":16,"sex":17,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":112},"100519479","phase-3-a-clinical-trial-to-evaluate-the-immunogenicity-and-safety-of-the-23-valent-pneumococcal-polysaccharide-vaccine-in-healthy-people-100519479","NCT06044077","A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People","A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Aged 2 Years and Above","Inclusion Criteria:\n\n1. Healthy subjects who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical examination and the researcher's judgment;\n2. Subjects who voluntarily participate and\u002For the subjects' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (subjects aged 8-17 years old must also sign an informed notification form);\n3. The subject and\u002For the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;\n4. \\*Axillary body temperature \\\u003C37.3°C on the day of enrollment. For criteria marked with an asterisk (\\*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.\n\nExclusion Criteria:\n\n1. Previous vaccination with marketed or experimental pneumococcal vaccines;\n2. Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;\n3. History or family history of convulsions, epilepsy, encephalopathy, and mental illness;\n4. Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including pneumococcal polysaccharide, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride), and have a history of vaccination-related fever (39℃ or above );\n5. Known severe congenital malformations, developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes that cannot be controlled by drugs, sickle cell anemia, Guillain-Barré syndrome);\n6. Known or suspected to have serious diseases including: severe respiratory diseases, severe digestive system diseases, severe endocrine system diseases, severe cardiovascular diseases, severe liver and kidney diseases, malignant tumors, severe skin diseases, etc.;\n7. Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months;\n8. Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable;\n9. Asplenia, functional asplenia or splenectomy;\n10. \\* In the acute infectious period (including recovery period) or acute exacerbation of chronic disease within 3 days before enrollment, or need or plan to use intravenous or oral steroids within 1 month after vaccination;\n11. \\* Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment;\n12. Women of childbearing age are pregnant ( Positive urine pregnancy test), breastfeeding or planning to prepare for pregnancy within six months; 13. \\*Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg in adults aged 18 years and above before enrollment;\n\n14\\. \\* Have received attenuated live vaccines within 14 days before vaccination, and received inactivated vaccines within 7 days; 15. Are participating in or plan to participate in clinical studies of other drugs or vaccines within 6 months after vaccination (immune persistence observation subjects in the vaccine who plan to vaccinate any marketed or unmarketed pneumococcal vaccine within 6 years after vaccination need to be excluded); 16. The investigators evaluate that they are not suitable for participating in the study.\n\nFor criteria marked with an asterisk (\\*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.","2 Years",{"count":217,"type":22},1920,[25],"This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.",[28],"2023-09-19",{"date":223,"type":33},"2023-09-21",{"date":225,"type":33},"2023-09-08",{"date":227,"type":22},"2029-07-31",{"name":229,"class":40},"Aimei Vacin BioPharm (Zhejiang) Co., Ltd."]