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

April 1, 2024 updated by: CanSino Biologics Inc.

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

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.
3420

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 3

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

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: 1A
Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old)
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
  • PCV13i
Active Comparator: 1B
Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old)
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
  • Prevnar
Experimental: 2A
Subjects received four doses of PCV13i at 3 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
  • PCV13i
Experimental: 3A
Subject received three doses of PCV13i at 7 to 11 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
  • PCV13i
Active Comparator: 3B
Subject received three doses of PCV13 at 7 to 11 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
  • Prevnar
Experimental: 4A
Subjects received two doses of PCV13i at 12 to 23 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
0.5mL,Intramuscular
Other Names:
  • PCV13i
Active Comparator: 4B
Subjects received two doses of PCV13 at 12 to 23 months of age
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
  • Prevnar
Active Comparator: 5A
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 Names:
  • PCV13i
Active Comparator: 5B
Subjects received one dose of PCV13 at 2 to 5 years old.
Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular
Other Names:
  • 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 of PCV13i in preventing pneumococcal infections
Time Frame: Within 7 days post each vaccination
Occurance of adverse reactions in all subjects
Within 7 days post each vaccination
Safety of PCV13i in preventing pneumococcal infections
Time Frame: Within 30 days post each vaccination
Occurance of adverse reactions in all subjects
Within 30 days post each vaccination
Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time Frame: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
30 days post three doses
Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)
Time Frame: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
30 days post three doses
Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)
Time Frame: 30 days post last dose of vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
30 days post last dose of vaccination
Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)
Time Frame: 30 days post vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
30 days post 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
Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time Frame: 30 days post three doses
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
30 days post three doses
Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time Frame: 30 days post three doses
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
30 days post three doses
Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time Frame: 6 months post one to three doses of vaccination
Occurance of SAE in subjects of this age group
6 months post one to three doses of vaccination
Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)
Time Frame: 30 days post two doses
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
30 days post two doses
Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Time Frame: 30 days post last dose of vaccination
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
30 days post last dose of vaccination
Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)
Time Frame: 30 days post two doses
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
30 days post two doses
Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Time Frame: 30 days post last dose of vaccination
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
30 days post last dose of vaccination
Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)
Time Frame: 6 months post two doses
Occurance of SAE in subjects of this age group
6 months post two doses
Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Time Frame: 6 months post last dose of vaccination
Occurance of SAE in subjects of this age group
6 months post last dose of 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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shengli Xia, Henan Province 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.
April 13, 2021

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.
March 30, 2022

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.
September 20, 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).
April 8, 2021

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.
April 8, 2021

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.
April 12, 2021

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.
April 2, 2024

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.
April 1, 2024

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-III

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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