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

Primary Purpose

Pneumococcal Infections, Streptococcal Infections, Bacterial Infections

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

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

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Safety, Immunogenicity

Eligibility Criteria

6 Weeks - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Neihuang Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Arm Description

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

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

Subjects received four doses of PCV13i at 3 months of age

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Safety of PCV13i in preventing pneumococcal infections

Occurance of adverse reactions in all subjects

Safety of PCV13i in preventing pneumococcal infections

Occurance of adverse reactions in all subjects

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

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

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

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT04841369

First Posted

April 8, 2021

Last Updated

October 28, 2022

Sponsor

CanSino Biologics Inc.

Collaborators

Henan Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04841369

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 13, 2021 (Actual)

Primary Completion Date

March 30, 2022 (Actual)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CanSino Biologics Inc.

Collaborators

Henan Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumococcal Infections, Streptococcal Infections, Bacterial Infections

Keywords

PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Safety, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

Subjects received four doses of PCV13i at 3 months of age

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

PCV13i

Intervention Description

0.5mL,Intramuscular

Intervention Type

Biological

Intervention Name(s)

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Other Intervention Name(s)

Prevnar

Intervention Description

0.5mL,Intramuscular

Primary Outcome Measure Information:

Title

Safety of PCV13i in preventing pneumococcal infections

Description

Occurance of adverse reactions in all subjects

Time Frame

Within 7 days post each vaccination

Title

Safety of PCV13i in preventing pneumococcal infections

Description

Occurance of adverse reactions in all subjects

Time Frame

Within 30 days post each vaccination

Title

Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

Description

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time Frame

30 days post three doses

Title

Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)

Description

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time Frame

30 days post three doses

Title

Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)

Description

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time Frame

30 days post last dose of vaccination

Title

Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)

Description

Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

Time Frame

30 days post vaccination

Secondary Outcome Measure Information:

Title

Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

Description

GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

Time Frame

30 days post three doses

Title

Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

Description

Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

Time Frame

30 days post three doses

Title

Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

Description

Occurance of SAE in subjects of this age group

Time Frame

6 months post one to three doses of vaccination

Title

Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)

Description

GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

Time Frame

30 days post two doses

Title

Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)

Description

GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio

Time Frame

30 days post last dose of vaccination

Title

Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)

Description

Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

Time Frame

30 days post two doses

Title

Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)

Description

Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml

Time Frame

30 days post last dose of vaccination

Title

Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)

Description

Occurance of SAE in subjects of this age group

Time Frame

6 months post two doses

Title

Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)

Description

Occurance of SAE in subjects of this age group

Time Frame

6 months post last dose of vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shengli Xia

Organizational Affiliation

Henan Province Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neihuang Center for Disease Control and Prevention

City

Anyang

State/Province

Henan

ZIP/Postal Code

450016

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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