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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumococcal Infectious Disease
• Intervention / Treatment: Biological: Sinovac PCV13; Biological: Prevnar®

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.

• Study Type: Interventional
• Enrollment (Estimated): 3080
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiaoqiang Liu; Phone Number: 15911568282; Email: lxq7611@126.com
• Study Contact Backup: Name: Yanxia Wang; Phone Number: 13613816598; Email: wangyanxia99@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial Center for Disease Control and Prevention
      • Contact: Yanxia Wang; Phone Number: 13613816598

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 during the study.

Exclusion Criteria:

1. Received any pneumococcal vaccine prior to enrollment;
2. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;
4. History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;
5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;
6. Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);
7. Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours.
8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
9. History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons;
10. 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.
11. 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.
12. 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.
13. Received other investigational drugs within 60 days prior to enrollment, or plan to receive 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 him or her unfit to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Sinovac PCV13; Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules.	Biological: Sinovac PCV13; One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.
Active Comparator: Active Comparator: Prevnar®; Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.	Biological: Prevnar®; One dose of Prevnar® (0.5 mL) is administered intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)	Proportion of serotype-specific IgG concentration ≥0.35 μg/ml	30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)	IgG GMC	30 days after primary vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)	Proportion of serotype-specific IgG concentration ≥0.35 μg/ml	30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)	IgG GMC	30 days after booster vaccination
Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8	Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8	30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)	Pneumococcal serotype-specific OPA antibody GMT	30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL	Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL	30 days after primary vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)	Pneumococcal serotype-specific IgG GMI	30 days after primary vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)	Pneumococcal serotype-specific OPA antibody GMI	30 days after primary vaccination
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL	Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL	30 days after booster vaccination
Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)	Pneumococcal serotype-specific IgG GMI	30 days after booster vaccination
Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)	Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)	30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)	Pneumococcal serotype-specific OPA antibody GMT	30 days after booster vaccination
Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)	Pneumococcal serotype-specific OPA antibody GMI	30 days after booster vaccination
Safety of Sinovac PCV13	Incidence of adverse reactions	0-30 days within each dose
Safety of Sinovac PCV13	Incidence of serious adverse events	6 months within final dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)	Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)	1,2,3 years after final dose
Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL	Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL	1,2,3 years after final dose
Pneumococcal serotype-specific IgG geometric mean concentration (GMC)	Pneumococcal serotype-specific IgG geometric mean concentration (GMC)	1,2,3 years after final dose
Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)	Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8	1,2,3 years after vaccination
Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) in participants aged 2-5 years	Pneumococcal serotype-specific OPA antibody GMT in participants aged 2-5 years	1,2,3 years after vaccination

Collaborators and Investigators

• Sponsor: Sinovac Life Sciences Co., Ltd.
• Investigators: Principal Investigator: Yanxia Wang, Henan Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Estimated): May 12, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Biological Products; Complex Mixtures; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Vaccines, Combined; Pneumococcal Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PRO-PCV-3001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No