Status:
ACTIVE_NOT_RECRUITING
A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Lead Sponsor:
Sinovac Research and Development Co., Ltd.
Conditions:
Pneumococcal Infectious Disease
Eligibility:
All Genders
6-5 years
Phase:
PHASE1
Brief Summary
A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 t...
Detailed Description
A phase Ⅰb clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children age...
Eligibility Criteria
Inclusion
- Healthy infants aged 2 months (42-89 days); Healthy children aged 2-5 years.
- Proven vaccination certificate, birth certificate and legal identification documents
- The participants' guardians can understand and voluntarily sign the informed consent form.
- Participants and their guardians can obey requirements of the protocol.
Exclusion
- Received any pneumococcal vaccine prior to enrollment.
- History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.
- History of allergy to the vaccine or vaccine components, including pneumococcal polysaccharide for each serotype, diphtheria CRM197, aluminum phosphate, succinic acid, polysorbate 80 and sodium chloride; or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma.
- History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days))
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc.
- Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation)
- Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors.
- Family history of mental illness, severe neurological disease (epilepsy or convulsions) or mental illness.
- History of thyroidectomy, asplenia, functional asplenia; and asplenia or splenectomy resulting from any condition.
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets), history of obvious bleeding or bruising after intramuscular injection or venipuncture.
- Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 6 months prior to enrollment had been treated with corticosteroids, other immunosuppressive agents (excluding corticosteroid spray therapy for allergic rhinitis, superficial corticosteroid therapy for acute non-concurrent dermatitis) or cytotoxic therapy for ≥14 days
- Infants 2 months of age (42-89 days) prior to enrollment/children 2 to 5 years of age 3 months prior to enrollment received blood products within the past 3 months (excluding hepatitis B immunoglobulin within 1 month).
- Receipt of other investigational drugs in the past 60 days or have the plan to participate in other clinical trials during this study.
- Receipt of attenuated live vaccines in the past 14 days.
- Receipt of inactivated or subunit vaccines in the past 7 days.
- Acute diseases or acute exacerbation of chronic diseases in the past 7 days.
- Axillary temperature ≥37.3 °C.
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 21 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06183216
Start Date
January 4 2024
End Date
July 21 2025
Last Update
April 17 2025
Active Locations (1)
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1
Binchuan County Center for Diseases Control and Prevention
Dali, Yunnan, China, 671600