Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR

December 9, 2020 updated by: China National Biotec Group Company Limited

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR)

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only.

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.

Study Overview

Status

Status

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

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.

Detailed Description

Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.

To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ MMR(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives MMR (0.5ml).

Blood samples will be collected before vaccination and 30 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

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 (Anticipated)

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.
600

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 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fenyang Tang
  • Phone Number: +86-25-83759419
  • Email: tfyepi@163.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • Recruiting
        • Anhui Provincial Center for Disease Control and Prevention
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Province Centers for Disease Control and Prevention
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Center for Disease Control and Prevention
        • Contact:

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 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
  • Subjects aged 18 months old at the date of recruitment;
  • With informed consent form (ICF) signed by parent(s) or guardian(s);
  • Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
  • Subjects have been vaccinated with a first dose of MMR, but have not been vaccinated with the 2nd dose of MMR and the booster (4th) dose of sIPV and DTaP;
  • No less than 14 days since the last dose of vaccination;
  • Axillary temperature ≤37.0℃.

Exclusion Criteria:

  • With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
  • Allergic to any ingredient of vaccine or with allergy history to any vaccine;
  • Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
  • Administration of immunoglobulins within 30 days prior to this study;
  • Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
  • With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
  • With any serious chronic illness, acute infectious diseases, or respiratory diseases;
  • With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
  • With any kind of infectious, purulent, or allergic skin diseases;
  • With any other factor that makes the investigator determines the subject is unsuitable for this study.

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: Single

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.
Active Comparator: group 2 (sIPV)
150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old
Biological: sIPV
sIPV at the age of 18 month old
Active Comparator: group 3 (DTaP)
150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old
Biological: DTaP
DTaP at the age of 18 month old
Experimental: group 1 (sIPV+DTaP+MMR)
150 subjects; simultaneously administration of sIPV+DTaP+MMR as booster immunization at the age of 18 months old, 0.5 ml each, respectively
Biological: sIPV+DTaP+MMR
sIPV+DTaP+MMR at the age of 18 month old
Active Comparator: group 4 (MMR)
150 subjects; vaccination of 0.5 ml MMR as booster immunization at the age of 18 months old
Biological: MMR
MMR at the age of 18 month old

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
Seroconversion rate (DTaP)
Time Frame: Baseline (before vaccination) results
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (sIPV)
Time Frame: Baseline (before vaccination) results
GMCs of poliovirus type I, II and III of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (DTaP)
Time Frame: Baseline (before vaccination) results
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Baseline (before vaccination) results
Seroconversion rate (sIPV)
Time Frame: Baseline (before vaccination) results
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Baseline (before vaccination) results
Seroconversion rate (sIPV)
Time Frame: Results obtained 30 days after vaccination
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Results obtained 30 days after vaccination
Seroconversion rate (DTaP)
Time Frame: Results obtained 30 days after vaccination
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Results obtained 30 days after vaccination
Seroconversion rate (MMR)
Time Frame: Baseline (before vaccination) results
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Baseline (before vaccination) results
Seroconversion rate (MMR)
Time Frame: Results obtained 30 days after vaccination
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (sIPV)
Time Frame: Results obtained 30 days after vaccination
GMCs of poliovirus type I, II and III of the subjects
Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (DTaP)
Time Frame: Results obtained 30 days after vaccination
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (MMR)
Time Frame: Baseline (before vaccination) results
GMCs of measles, mumps, rubella antibodies of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (MMR)
Time Frame: Results obtained 30 days after vaccination
GMCs of measles, mumps, rubella antibodies of the subjects
Results obtained 30 days after 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
Adverse Events Following Immunization (AEFI)
Time Frame: 0-6 months
analyse the incidence of adverse events following immunization, both solicited and unsolicited
0-6 months

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.
China National Biotec Group Company Limited

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.
Peking University
Beijing Institute of Biological Products Co Ltd.
Sichuan Center for Disease Control and Prevention
National Institutes for Food and Drug Control, China
Jiangsu Province Centers for Disease Control and Prevention
Chengdu Institute of Biological Products Co.,Ltd.
Anhui Provincial 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: Fenyang Tang, Jiangsu Province Centers 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.
November 13, 2020

Primary Completion (Anticipated)

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.
September 1, 2021

Study Completion (Anticipated)

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.
December 1, 2021

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).
November 17, 2020

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.
November 17, 2020

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.
November 20, 2020

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.
December 10, 2020

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.
December 9, 2020

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.
December 1, 2020

More Information

Terms related to this study

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.
  • sIPV-DTaP-MMR-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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