Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine

Last updated: January 26, 2026
Sponsor: Sinovac Life Sciences Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Sinovac PCV13

Prevnar®

Clinical Study ID

NCT06617715
PRO-PCV-3001
  • Ages 6-5
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. 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);

  2. Participants' guardians provide legal identity document and participants'vaccination record;

  3. Participants' guardians understand and voluntarily sign the informed consent form;

  4. Participants' guardians can follow all study procedures and stay in contact duringthe study.

Exclusion

Exclusion Criteria:

  1. Received any pneumococcal vaccine prior to enrollment;

  2. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused byStreptococcus pneumoniae, as confirmed by laboratory tests;

  3. History of allergy or adverse reactions to the vaccine or vaccine components, orhistory of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;

  4. History of dystocia, asphyxia rescue and nervous system damage at birth for infantsunder 2 years of age;

  5. Congenital malformations or developmental disorders, genetic defects, severemalnutrition, history of asthma;

  6. Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiencydiseases or immunosuppressive diseases (such as AIDS, organ transplantation);

  7. Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignanttumours.

  8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) ormental illness or have a family history of such diseases.

  9. History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomycaused by any reasons;

  10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulationfactors, blood coagulopathy, abnormal platelets level), history of obvious bleeding,hematoma or bruising after intramuscular injection or venipuncture.

  11. Consecutively received ≥14 days of corticosteroid, any other immunosuppressivetherapy (excluding corticosteroid spray therapy for allergic rhinitis and surfacecorticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapyprior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior toenrollment for children aged 7 months to 5 years.

  12. Received blood products prior to enrollment for children aged 2 months or within 3months prior to enrollment for children aged 7 months to 5 years. Receipt ofHepatitis B immunoglobulin one month prior to enrollment is an exception.

  13. Received other investigational drugs within 60 days prior to enrollment, or plan toreceive such drugs during the study;

  14. Received live attenuated vaccine within 14 days prior to enrollment;

  15. Received subunit or inactivated or other vaccine within 7 days prior to enrollment;

  16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment;

  17. Had fever (axillary temperature≥ 37.3 Degree Celsius) before vaccination;

  18. In the investigator's judgment, the participant has any other factors that make himor her unfit to participate in the clinical trial.

Study Design

Total Participants: 3080
Treatment Group(s): 2
Primary Treatment: Sinovac PCV13
Phase: 3
Study Start date:
October 23, 2024
Estimated Completion Date:
July 30, 2026

Study 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.

Connect with a study center

  • Henan Provincial Center for Disease Control and Prevention

    Zhengzhou, Henan
    China

    Site Not Available

  • Henan Provincial Center for Disease Control and Prevention

    Zhengzhou 1784658, Henan 1808520
    China

    Active - Recruiting

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