Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years

NCT07300644 | Recruiting Phase 2

• 1 other identifier: PRO-PCV24-1005
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase 2 clinical trial.

Conditions

Pneumococcal Infectious Disease

Keywords

PCV24; Phase 2

Outcome Measures

Primary Outcomes (2)

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

  30 days after primary vaccination

• Incidence of adverse reactions

  0-30 days after vaccination

Secondary Outcomes (4)

• Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)

  30 days after the 2nd dose of the primary vaccination (2-month-olds), 30 days after primary vaccination (all participants)

• OPA antibody levels for each pneumococcal serotype

  30 days after vaccination

• Incidence of adverse reactions

  0-7 days after vaccination

• Incidence of serious adverse events (SAE)

  from vaccination to 6 months after final dose

Study Arms (2)

Sinovac PCV24

EXPERIMENTAL

Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.

Biological: Sinovac PCV24

Prevnar®

ACTIVE COMPARATOR

Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

Biological: Prevnar®

Interventions

Sinovac PCV24 BIOLOGICAL

Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.

Sinovac PCV24

Prevnar® BIOLOGICAL

Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

Prevnar®

Eligibility Criteria

• Age: 42 Days - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months, and 2-5 years;
• The participants' guardian provides a legal identity document and the participants' vaccination record;
• The participant's guardian understands and voluntarily signs the informed consent form;
• 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 invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
• History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
• Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months);
• History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);
• Severe congenital malformations or developmental disorders, genetic defects, or malnutrition;
• Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
• Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelet levels);
• Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study;
• Receipt of immunoglobulins or other blood products within 3 months prior to administration of the investigational vaccine (except for hepatitis B immunoglobulin or rabies immunoglobulin used within 1 month), or planned use of such products during the study period;
• Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
• Received live attenuated vaccine within 14 days prior to enrollment;
• Received subunit or inactivated vaccine within 7 days prior to enrollment;
• Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (3)

Qichun District Center for Disease Prevention and Control

Huanggang, Hubei, China

RECRUITING

Xiangzhou District Center for Disease Prevention and Control

Xiangyang, Hubei, China

RECRUITING

Xian'an District Center for Disease Prevention and Control

Xianning, Hubei, 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

Central Study Contacts

Ye-qing Tong

CONTACT

+86 13971078410; 63382251@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 24, 2025
• First Posted: December 24, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)