Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (NCT05092386) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
China310 participantsStarted 2023-01-03
Plain-language summary
This study is an open-label combined randomized double-blind, positive control phase â… clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine
Who can participate
Age range6 Weeks – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 \~ 11 months, healthy infants aged 12\~ 23 months, healthy children aged 2\~ 5 years, healthy adolescent and children aged 6\~ 17 years, healthy adults aged 18\~ 49 yearsï¼›
* Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)ï¼›
* The subject and/or guardian can understand and voluntarily sign the informed consent form.
Exclusion Criteria:
* Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine;
* Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture;
* History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
* Autoimmune disease or immunodeficiency / immunosuppression;
* Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance;
* Diag…
What they're measuring
1
Safety index-incidence of adverse reactions
Timeframe: Day 0-30 after each dose of experimental vaccine