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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
237

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: vaccine 1A
Subjects received one dose of PCV13i at 18 to 49 years old
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 2A
Subjects received one dose of PCV13i at 50 years old and above
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 3A
Subjects received one dose of PCV13i at 6 to 17 years old
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 4A
Subjects received one dose of PCV13i at 2 to 5 years old
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 5A
Subjects received two doses of PCV13i at 7 months to 2 years old
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 6A
Subjects received three doses of PCV13i at 3,4,5 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 7A
Subjects received three doses of PCV13i at 2,4,6 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular other name:PCV13i
Active Comparator: vaccine 7B
Subjects received three doses of PCV13 at 2,4,6 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular other name:Prevnar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CanSino Biologics Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Henan Center for Disease Control and Prevention

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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