Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine

NCT06617715 | Recruiting Phase 3

• 1 other identifier: PRO-PCV-3001
• Study Type: interventional
• Target: 3,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)

  30 days after booster vaccination

• Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)

  30 days after booster vaccination

• Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8

  30 days after primary vaccination

• Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)

  30 days after primary vaccination

• Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL

  30 days after primary vaccination

Other Outcomes (5)

• 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

  1,2,3 years after final dose

• Pneumococcal serotype-specific IgG geometric mean concentration (GMC)

  1,2,3 years after final dose

Study Arms (2)

Experimental: Sinovac PCV13

EXPERIMENTAL

Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules.

Biological: Sinovac PCV13

Active Comparator: Prevnar®

ACTIVE COMPARATOR

Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.

Biological: Prevnar®

Interventions

Sinovac PCV13 BIOLOGICAL

One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.

Experimental: Sinovac PCV13

Prevnar® BIOLOGICAL

One dose of Prevnar® (0.5 mL) is administered intramuscularly.

Active Comparator: Prevnar®

Eligibility Criteria

• Age: 6 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Yanxia Wang

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxia Wang

CONTACT

13613816598; wangyanxia99@163.com

Xiaoqiang Liu

CONTACT

15911568282; lxq7611@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: September 27, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): May 12, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)