Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

CanSino Biologics

Status and phase: Completed; Phase 3

Conditions: Streptococcal Infections; Pneumococcal Infections; Bacterial Infections

Treatments: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine; Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04841369

CS-CTP-PCV-III

Details and patient eligibility

About

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.

Enrollment: 3,420 patients

Sex: All

Ages: 6+ weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,420 participants in 9 patient groups

1A

Experimental group

Description:

Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old)

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

1B

Active Comparator group

Description:

Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old)

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

2A

Experimental group

Description:

Subjects received four doses of PCV13i at 3 months of age

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

3A

Experimental group

Description:

Subject received three doses of PCV13i at 7 to 11 months of age

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

3B

Active Comparator group

Description:

Subject received three doses of PCV13 at 7 to 11 months of age

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

4A

Experimental group

Description:

Subjects received two doses of PCV13i at 12 to 23 months of age

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

4B

Active Comparator group

Description:

Subjects received two doses of PCV13 at 12 to 23 months of age

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

5A

Active Comparator group

Description:

Subjects received one dose of PCV13i at 2 to 5 years old.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

5B

Active Comparator group

Description:

Subjects received one dose of PCV13 at 2 to 5 years old.

Treatment:

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine