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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841369
• Other study ID #: CS-CTP-PCV-III
• Status: Completed
• Phase: Phase 3
• Start date: April 13, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3420
• Est. completion date: September 20, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections
• Pneumococcal Infections
• Streptococcal Infections

Intervention

Biological:
• 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular
• 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular

Locations

Country	Name	City	State
China	Neihuang Center for Disease Control and Prevention	Anyang	Henan

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Henan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of PCV13i in preventing pneumococcal infections	Occurance of adverse reactions in all subjects	Within 7 days post each vaccination
Primary	Safety of PCV13i in preventing pneumococcal infections	Occurance of adverse reactions in all subjects	Within 30 days post each vaccination
Primary	Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)	Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml	30 days post three doses
Primary	Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)	Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml	30 days post three doses
Primary	Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)	Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml	30 days post last dose of vaccination
Primary	Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)	Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml	30 days post vaccination
Secondary	Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)	GMT of serotype-specific OPA antibody with the titer of =1:8 ratio	30 days post three doses
Secondary	Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)	Serotype-specific Immunoglobulin G with a concentration of =1.0µg/ml	30 days post three doses
Secondary	Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)	Occurance of SAE in subjects of this age group	6 months post one to three doses of vaccination
Secondary	Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)	GMT of serotype-specific OPA antibody with the titer of =1:8 ratio	30 days post two doses
Secondary	Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)	GMT of serotype-specific OPA antibody with the titer of =1:8 ratio	30 days post last dose of vaccination
Secondary	Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)	Serotype-specific Immunoglobulin G with a concentration of =1.0µg/ml	30 days post two doses
Secondary	Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)	Serotype-specific Immunoglobulin G with a concentration of =1.0µg/ml	30 days post last dose of vaccination
Secondary	Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)	Occurance of SAE in subjects of this age group	6 months post two doses
Secondary	Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)	Occurance of SAE in subjects of this age group	6 months post last dose of vaccination