RecruitingPhase 3NCT06617715

Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine

A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants

Sponsor

Sinovac Life Sciences Co., Ltd.

Enrollment

3,080 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Pneumococcal Infectious Disease

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.

Eligibility

Min Age: 6 WeeksMax Age: 5 Years

Inclusion Criteria4

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.

Exclusion Criteria18

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.