PCV24 vaccine for infants aged 2 to 23 months

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

A randomized, double-blind, positive-controlled Phase 1b trial will enroll at least 180 healthy Chinese infants aged 2 months (≥42 days) to 23 months and randomize them 1:1 to receive either Sinovac's PCV24 or Pfizer's Prevnar13. The primary goals are to monitor safety and measure immune responses to the 24 pneumococcal serotypes included in PCV24. Safety will be tracked through observation of adverse events and serious adverse events, and immunogenicity will be measured by blood antibody levels at scheduled visits. The trial is conducted at provincial and county CDC sites in Shandong province, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;
2. Participants' guardian provides legal identity document and participants' vaccination record;
3. Participants' guardian understands and voluntarily signs the informed consent form;
4. 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 or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
3. History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
4. Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months);
5. 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);
6. Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
7. 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;
8. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture).
10. Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but febrile convulsion is not an exclusion criteria ) or mental illness or have a family history of such diseases.
11. 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.
12. Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
13. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
14. Received live attenuated vaccine within 14 days prior to enrollment;
15. Received subunit or inactivated vaccine within 7 days prior to enrollment;
16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;
17. 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

• Shanxian Center for Disease Control and Prevention
  Shancheng, Shandong, China Recruiting
• Shandong Provincial Center for Disease Control and Prevention
  Jinan, Shandong, China Not yet recruiting

Study contacts

• Principal investigator: Qing Xu — Shandong Provincial Center for Disease Control and Prevention
• Study coordinator: Qing Xu
• Email: xqepi@163.com
• Phone: 18853165516

Similar studies

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

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• Group ACYW135 meningococcal vaccine in children 6-11 months

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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.