Phase I Clinical Trial of a Candidate PCV13 in Healthy People

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.

Inclusion Criteria:Satisfy the age requirements of the clinical trial; willing to provide proof of identity;Subjects or guardians must provide informed consent forms with personal signature and date;Male and female of childbearing age should agree to take effective contraception measures;Subjects or guardians can obey the requirements of the clinical study;Axillary temperature below 37.3 °C.Exclusion Criteria:Laboratory indicators (expect those have no clinical significance) out of normal ranges required;Received any pneumococcal vaccine;Allergic history to any drugs, vaccine or vaccine-related component;Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;Infants diagnosed with pathological jaundice that lasts for 2~4 weeks and occurs repeatedly;Breast-feeding or pregnant women, or positive U-HCG;High blood pressure uncontrolled by medication;Known or suspected immune deficiency or immune suppression;Serious congenital malformation, history of organ resection or serious chronic illness;Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin);History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae;History of convulsions, epilepsy or encephalopathy or a family history of mental illness;A vaccination-related contraindications that other investigator believes;Plans to participate in or is participating in any other clinical study;Any other factors judged by investigator that may interfere subject's compliance with the protocol.