- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100772
Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)
October 28, 2022 updated by: CanSino Biologics Inc.
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
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
237
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Anyang, Henan, China, 450016
- Neihuang Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vaccine 1A
Subjects received one dose of PCV13i at 18 to 49 years old
|
0.5mL,Intramuscular other name:PCV13i
|
Experimental: vaccine 2A
Subjects received one dose of PCV13i at 50 years old and above
|
0.5mL,Intramuscular other name:PCV13i
|
Experimental: vaccine 3A
Subjects received one dose of PCV13i at 6 to 17 years old
|
0.5mL,Intramuscular other name:PCV13i
|
Experimental: vaccine 4A
Subjects received one dose of PCV13i at 2 to 5 years old
|
0.5mL,Intramuscular other name:PCV13i
|
Experimental: vaccine 5A
Subjects received two doses of PCV13i at 7 months to 2 years old
|
0.5mL,Intramuscular other name:PCV13i
|
Experimental: vaccine 6A
Subjects received three doses of PCV13i at 3,4,5 months of age
|
0.5mL,Intramuscular other name:PCV13i
|
Experimental: vaccine 7A
Subjects received three doses of PCV13i at 2,4,6 months of age
|
0.5mL,Intramuscular other name:PCV13i
|
Active Comparator: vaccine 7B
Subjects received three doses of PCV13 at 2,4,6 months of age
|
0.5mL,Intramuscular other name:Prevnar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety items of adverse reactions
Time Frame: within 7 days post each vaccination
|
Occurrence of adverse reactions of each subject(Arm 1A-7B)
|
within 7 days post each vaccination
|
Safety items of SAE
Time Frame: within 6 months post last vaccination
|
Occurrence of SAE of each subject(Arm 1A-7B)
|
within 6 months post last vaccination
|
Safety items of Hematological examination
Time Frame: day 4 post vaccination
|
Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)
|
day 4 post vaccination
|
Safety items of Urine test
Time Frame: day 4 post vaccination
|
Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)
|
day 4 post vaccination
|
Safety items of Blood chemistry test
Time Frame: day 4 post vaccination
|
Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)
|
day 4 post vaccination
|
Safety items of pressure value
Time Frame: day 4 post vaccination
|
Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)
|
day 4 post vaccination
|
Safety items of heart rate
Time Frame: day 4 post vaccination
|
Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)
|
day 4 post vaccination
|
Safety items of adverse reactions
Time Frame: within 30 days post each vaccination
|
Occurrence of adverse reactions of each subject(Arm 1A-7B)
|
within 30 days post each vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
immunogencity items of seropositivity rates by ELISA
Time Frame: day 30 post last vaccination
|
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)
|
day 30 post last vaccination
|
immunogencity items of GMC by ELISA
Time Frame: day 30 post last vaccination
|
Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
|
day 30 post last vaccination
|
immunogencity items of GMI by ELISA
Time Frame: day 30 post last vaccination
|
Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
|
day 30 post last vaccination
|
immunogencity items of GMT
Time Frame: day 30 post last vaccination
|
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)
|
day 30 post last vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2020
Primary Completion (Actual)
June 23, 2021
Study Completion (Actual)
August 23, 2022
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
September 20, 2019
First Posted (Actual)
September 24, 2019
Study Record Updates
Last Update Posted (Actual)
October 31, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS-CTP-PCV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
In order to maintain the rights of the subject, do not open the IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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