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

NCT ID: NCT04100772

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-18
• Study Completion Date: 2022-08-23

Brief Summary

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.

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

vaccine 1A

Subjects received one dose of PCV13i at 18 to 49 years old

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 2A

Subjects received one dose of PCV13i at 50 years old and above

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 3A

Subjects received one dose of PCV13i at 6 to 17 years old

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 4A

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 5A

Subjects received two doses of PCV13i at 7 months to 2 years old

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 6A

Subjects received three doses of PCV13i at 3,4,5 months of age

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 7A

Subjects received three doses of PCV13i at 2,4,6 months of age

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PCV13i

vaccine 7B

Subjects received three doses of PCV13 at 2,4,6 months of age

Group Type: ACTIVE_COMPARATOR

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:Prevnar

Interventions

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

0.5mL,Intramuscular other name:PCV13i

Intervention Type: BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

0.5mL,Intramuscular other name:Prevnar

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xia Shengli

Role: PRINCIPAL_INVESTIGATOR

Henan Province Center for Disease Control and Prevention

Locations

Neihuang Center for Disease Control and Prevention

Anyang, Henan, China

Countries

China

Other Identifiers

CS-CTP-PCV

Identifier Type: -

Identifier Source: org_study_id