Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above

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 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.

Inclusion Criteria:

• healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
• Willing to provide proof of identity;
• Without vaccination history of pneumococcal vaccine;
• None-pregnancy or do not plan to pregnancy recently;;
• Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
• Volunteers of 8-17 years old and their guardians who willing sign informed consent;
• Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
• Able and willing comply with the requirements of the protocol ;

Exclusion Criteria:

• Volunteers whose axillary body temperature was >37.0℃ before vaccination
• Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
• Volunteers who has a history of epilepsy, convulsions or psychosis;
• -Allergic person;
• Any prior administration of blood products in last 3 month;
• Any prior administration of other research medicines in last 1 month;
• Plans to participate in or is participating in any other drug clinical study;
• Any prior administration of attenuated live vaccine in last 14 days;
• Any prior administration of subunit or inactivated vaccines in last 7 days;
• Had fever before vaccination, Volunteers with temperature >37.0°C on axillary setting;
• According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial