Testing a new pneumococcal vaccine in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial evaluates the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd. The study will involve healthy children aged 2 months to 5 years, who will be randomized into two groups to receive either the Sinovac PCV13 or the active control vaccine, Prevenar13®. The trial aims to enroll at least 3080 participants and will be conducted in a double-blind manner to ensure unbiased results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan Provincial Center for Disease Control and Prevention
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Yanxia Wang — Henan Provincial Center for Disease Control and Prevention
• Study coordinator: Yanxia Wang
• Email: wangyanxia99@163.com
• Phone: 13613816598

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 24‑valent pneumococcal conjugate vaccine (PCV24) for children aged 2 months to 5 years

  This will test whether Sinovac's 24‑valent pneumococcal vaccine (PCV24) is safe and triggers protective immune responses in children aged 2 months to 5 years, compared with the licensed Prevnar13 vaccine.

  Recruiting at 3 sites Phase 2 Sinovac Biotech Co., Ltd · Huanggang, Hubei and 2 other locations · NCT07300644

• PCV24 vaccine for infants aged 2 to 23 months

  This will test whether the new 24‑valent PCV24 vaccine is safe and produces protective immune responses in healthy infants aged 2 to 23 months, compared with the standard Prevnar13 vaccine.

  Recruiting Phase 1 Sinovac Biotech Co., Ltd · Jinan, Shandong and 1 other locations · NCT06800261

• How long immunity lasts after inactivated hepatitis A vaccine

  This study tests if immunity from the inactivated hepatitis A vaccine lasts up to 20 years in adults who completed the vaccination course in a prior trial.

  Recruiting Sinovac Biotech Co., Ltd · Changzhou, Jiangsu · NCT07889219

• Hepatitis A vaccine study to see how well different doses work in adults and kids

  This Phase 3 study tests two doses of Healive for safety and immune response in adults and children, with adults receiving a single actively treated dose and children randomly receiving Healive or another HepA vaccine.

  Recruiting Phase 3 Sinovac Biotech Co., Ltd · Hanoi · NCT07793227

• Meningococcal vaccine for children 12–23 months old (Group ACYW135)

  This study tests whether the new Group ACYW135 meningococcal vaccine in healthy children aged 12 to 23 months can provoke a similar immune response and has an acceptable safety profile compared with a licensed vaccine.

  Recruiting at 2 sites Phase 3 Sinovac Biotech Co., Ltd · Nanning, Guangxi and 1 other locations · NCT07505836

• Group ACYW135 meningococcal vaccine in children 6-11 months

  This trial tests whether the investigational meningococcal vaccine in healthy infants aged 6 to 11 months can provoke a strong immune response with good safety compared with a licensed vaccine.

  Recruiting at 2 sites Phase 3 Sinovac Biotech Co., Ltd · Nanning, Guangxi and 1 other locations · NCT07505823

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.