Testing a new pneumococcal vaccine in children aged 2-17 years

A Randomized, Double-blind, Controlled Combined With Open-label Phase Ia Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2-17 Years.

This study is testing a new pneumococcal vaccine for children aged 2-17 years to see how safe it is and how well it works compared to an existing vaccine.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Sinovac Biotech Co., Ltd (industry)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06550830 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and immunogenicity of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd in children aged 2-17 years. The study is designed as a randomized, double-blind, controlled trial combined with an open-label phase Ia approach. A total of at least 114 participants will be enrolled, with children aged 2-5 years receiving either PCV24 or the active control vaccine Prevenar13®, while those aged 6-17 years will receive different formulations of PCV24. The trial aims to determine how well the vaccine works and its safety profile in this age group.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy children aged 2-17 years who have not received any pneumococcal vaccine prior to enrollment.

Not a fit: Patients with a history of invasive pneumococcal diseases or severe allergies to vaccine components may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide enhanced protection against pneumococcal infectious diseases in children.

How similar studies have performed: Other studies have shown success with similar pneumococcal vaccines, indicating a promising approach to enhancing immunization in children.

Eligibility criteria

Inclusion Criteria:

1. Healthy volunteers who are aged 2-17 years;
2. Participants and their guardians provide legal proof of identity, as well as vaccination record (for children aged 2-5 years);
3. Participants' guardians understand and voluntarily sign the informed consent form; participants aged 8-17 years sign the written assent;
4. Participants 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 invasive pneumococcal diseases (IPDs) or other pneumococcal diseases 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 anaphylactic shock;
4. Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
5. 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;
6. Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)
7. 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.
8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
9. Long-term alcohol or drug abuse.
10. 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.
11. Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment during the study period;
12. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
13. Received live attenuated vaccine within 14 days prior to enrollment;
14. Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
15. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;
16. Women who are pregnant or breastfeeding (if applicable);
17. Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant.
18. Had fever (axillary temperature\> 37.0℃) before vaccination;
19. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine) — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Kai Chu — Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
• Study coordinator: Kai Chu

Conditions: Pneumococcal Infectious Disease