Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
- Conditions
- Pneumococcal Infectious Disease
- Interventions
- Biological: Sinovac PCV13Biological: Prevnar®
- Registration Number
- NCT06617715
- Lead Sponsor
- Sinovac Life Sciences Co., Ltd.
- Brief Summary
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.
- Detailed Description
A phase Ⅲ 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 pediatric population aged 2 months (minimum 6 weeks)-5 years (before the 6th birthday). The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®. A total of at least 3080 participants aged 6 weeks to 5 years will be enrolled. Participants will be randomized in 1:1 ratio to the test group or control group.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3080
- 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);
- Participants' guardians provide legal identity document and participants' vaccination record;
- Participants' guardians understand and voluntarily sign the informed consent form;
- Participants' guardians can follow all study procedures and stay in contact during the study.
- Received any pneumococcal vaccine prior to enrollment;
- History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
- History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;
- History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;
- Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);
- Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours.
- Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
- History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons;
- 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.
- 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.
- 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.
- Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs during the study;
- Received live attenuated vaccine within 14 days prior to enrollment;
- Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
- Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment;
- Had fever (axillary temperature≥ 37.3 Degree Celsius) before vaccination;
- In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Sinovac PCV13 Sinovac PCV13 Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules. Active Comparator: Prevnar® Prevnar® Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.
- Primary Outcome Measures
Name Time Method Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after primary vaccination Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after primary vaccination IgG GMC
- Secondary Outcome Measures
Name Time Method Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after booster vaccination Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after booster vaccination IgG GMC
Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8 30 days after primary vaccination Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) 30 days after booster vaccination Pneumococcal serotype-specific OPA antibody GMT
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL 30 days after booster vaccination Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) 30 days after booster vaccination Pneumococcal serotype-specific IgG GMI
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI) 30 days after booster vaccination Pneumococcal serotype-specific OPA antibody GMI
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate) 30 days after booster vaccination Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)
Safety of Sinovac PCV13 6 months within final dose Incidence of serious adverse events
Trial Locations
- Locations (1)
Henan Provincial Center for Disease Control and Prevention
🇨🇳Zhengzhou, Henan, China