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

Primary Purpose

Pneumococcal Infections, Streptococcal Infections, Bacterial Infections

Status

Completed

Phase

Phase 1

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 Type

Experimental

Active Comparator

Arm Label

vaccine 1A

vaccine 2A

vaccine 3A

vaccine 4A

vaccine 5A

vaccine 6A

vaccine 7A

vaccine 7B

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Safety items of adverse reactions

Occurrence of adverse reactions of each subject(Arm 1A-7B)

Safety items of SAE

Occurrence of SAE of each subject(Arm 1A-7B)

Safety items of Hematological examination

Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)

Safety items of Urine test

Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)

Safety items of Blood chemistry test

Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)

Safety items of pressure value

Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)

Safety items of heart rate

Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)

Safety items of adverse reactions

Occurrence of adverse reactions of each subject(Arm 1A-7B)

Secondary Outcome Measures

immunogencity items of seropositivity rates by ELISA

Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)

immunogencity items of GMC by ELISA

Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)

immunogencity items of GMI by ELISA

Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)

immunogencity items of GMT

Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA in subjects aged 2 months post last vaccination(7A、7B)

Full Information

NCT ID

NCT04100772

First Posted

September 18, 2019

Last Updated

October 28, 2022

Sponsor

CanSino Biologics Inc.

Collaborators

Henan Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04100772

Brief Title

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

Acronym

PICTPCV13i

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

May 18, 2020 (Actual)

Primary Completion Date

June 23, 2021 (Actual)

Study Completion Date

August 23, 2022 (Actual)

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 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

237 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vaccine 1A

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine 2A

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine 3A

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine 4A

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine 5A

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine 6A

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine 7A

Arm Type

Experimental

Arm Description

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

Arm Title

vaccine 7B

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

0.5mL,Intramuscular other name:PCV13i

Intervention Type

Biological

Intervention Name(s)

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Intervention Description

0.5mL,Intramuscular other name:Prevnar

Primary Outcome Measure Information:

Title

Safety items of adverse reactions

Description

Occurrence of adverse reactions of each subject(Arm 1A-7B)

Time Frame

within 7 days post each vaccination

Title

Safety items of SAE

Description

Occurrence of SAE of each subject(Arm 1A-7B)

Time Frame

within 6 months post last vaccination

Title

Safety items of Hematological examination

Description

Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)

Time Frame

day 4 post vaccination

Title

Safety items of Urine test

Description

Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)

Time Frame

day 4 post vaccination

Title

Safety items of Blood chemistry test

Description

Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)

Time Frame

day 4 post vaccination

Title

Safety items of pressure value

Description

Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)

Time Frame

day 4 post vaccination

Title

Safety items of heart rate

Description

Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)

Time Frame

day 4 post vaccination

Title

Safety items of adverse reactions

Description

Occurrence of adverse reactions of each subject(Arm 1A-7B)

Time Frame

within 30 days post each vaccination

Secondary Outcome Measure Information:

Title

immunogencity items of seropositivity rates by ELISA

Description

Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)

Time Frame

day 30 post last vaccination

Title

immunogencity items of GMC by ELISA

Description

Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)

Time Frame

day 30 post last vaccination

Title

immunogencity items of GMI by ELISA

Description

Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)

Time Frame

day 30 post last vaccination

Title

immunogencity items of GMT

Description

Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA in subjects aged 2 months post last vaccination(7A、7B)

Time Frame

day 30 post last 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

Xia Shengli

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

Plan to Share IPD

IPD Sharing Plan Description

In order to maintain the rights of the subject, do not open the IPD

Learn more about this trial

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

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