Clinical Trial of PCV24 in Children Aged 2-17 Years

NCT06550830 | Completed Phase 1

• 1 other identifier: PRO-PCV24-1002
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia clinical trial.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

  Incidence of adverse reactions within 30 days after vaccination

  0-30 days after vaccination

Secondary Outcomes (12)

• Incidence of adverse reactions

  0-7 days after vaccination

• Incidence of serious adverse events (SAE)

  0-6 months after vaccination

• Incidence of clinically significant abnormality in laboratory examination tests

  0-3 days after vaccination

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

  30 days after vaccination

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

  30 days after vaccination

Study Arms (3)

Experimental group 1

EXPERIMENTAL

12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.

Biological: Sinovac PCV24 formulation 1

Experimental group 2

EXPERIMENTAL

12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.

Biological: Sinovac PCV24 formulation 2

Active control group

ACTIVE COMPARATOR

30 participants aged 2-5 years will be randomized to receive Prevenar13®. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.

Biological: Prevenar13®

Interventions

Sinovac PCV24 formulation 2 BIOLOGICAL

One dose of Sinovac PCV24 formulation 2(0.5mL)

Experimental group 2

Prevenar13® BIOLOGICAL

One dose of PCV13 manufactured by Pfizer

Active control group

Sinovac PCV24 formulation 1 BIOLOGICAL

One dose of Sinovac PCV24 formulation 1(0.5mL)

Experimental group 1

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy volunteers who are aged 2-17 years;
• Participants and their guardians provide legal proof of identity, as well as vaccination record (for children aged 2-5 years);
• Participants' guardians understand and voluntarily sign the informed consent form; participants aged 8-17 years sign the written assent;
• Participants 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 invasive pneumococcal diseases (IPDs) or other pneumococcal diseases 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 anaphylactic shock;
• Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
• Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as cardiovascular diseases (e.g. congenital heart disease), metabolic diseases (such as diabetes), 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 or 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 platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
• Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
• Long-term alcohol or drug abuse.
• Have received \> 14 days of immunosuppressive or other immunomodulatory therapy in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period.
• Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment 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 or other vaccine within 7 days prior to enrollment;
• Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

• Kai Chu

  Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple for children aged 2-5 years; open-label for children aged 6-17 years
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 13, 2024
• Study Start: September 7, 2024
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)