Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)

Starting soon · Phase 3

Conditions studied: Pneumococcal Infectious Diseases

In brief

A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.

Key facts

Study ID

NCT07593924

Run by

Sinovac Life Sciences Co., Ltd.

People needed

500

Starts

2026-05-01

Expected to finish

2027-07-01

Last updated by the study team

2026-05-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Health infants aged approximately 2 months (42 to 89 days)
• Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
• Be able to provide the vaccination records since birth.
• The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).

You may not qualify if…

• Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation;
• Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
• Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old.
• History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component.
• History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae.
• Premature infants (born before week 37 of gestation).
• Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition.
• Autoimmune diseases or immunodeficiency/immunosuppression.
• Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
• Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
• Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation.
• Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation.
• Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation.
• Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment.
• Received subunit or inactivated vaccines within 7 days before enrollment.
• Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
• Axillary temperature ≥ 37.5°C before enrollment.
• Any other factors judged by the investigators as unsuitable for participation.

Where it is running

• Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences — Imus, Cavite, Philippines

Full record on ClinicalTrials.gov

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