To Evaluate the Safety and Primary Immunogenicity of Cell-free (Three-component) Combination Vaccine for Phase I Immunogenicity in Children and Infants

A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine.Main purpose: To evaluate the safety of the adsorbed cell-free whitening break (three components) combination vaccine;Secondary purpose: To preliminarily evaluate the immunogenicity of the adsorbed cell-free whitening break (three components) combination vaccine.

Study Overview

• Status: Recruiting
• Conditions: Safety、Immunogenicity
• Intervention / Treatment: Biological: A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine

Detailed Description

Main endpoint:

1. Adverse events within 30 minutes after vaccination of each test dose;
2. occurrence of solicitation adverse events within 0-7 days after vaccination of each dose;
3. The occurrence of non-solicitation adverse events within 0-30 days after vaccination for each test dose;
4. occurrence of serious adverse events 6 months after the first dose of immunization to the whole immunization.

Secondary endpoint:

1. Abnormal occurrence of laboratory test indicators on day 4 after immunization between 4 and 6 years old age groups;
2. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with the cell-free whitening break (three components) for 30 days after the full basal immunization in the 3-month age group;
3. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with cell-free leucocyte (three-component) adsorption at 30 days after 18 to 24 months of age immunization.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoping Zhu; Phone Number: 0852-85596863; Email: xiaopingzhu98@163.com

Study Locations

• China
  • Sichuan
    • Mianyang City, Sichuan, China, 621100
      • Recruiting
      • Santai County Center for Disease Control and Prevention
      • Contact: Yulin Jing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Permanent and healthy people aged 4-6 years old, 18-24 years old, and March age group (90-119 days);
2. Children between the ages of 4 and 6 who complete the whole immunization (4 doses) and do not receive diphtheria tetanus combination vaccine according to diphtheria and immunization program procedures;
3. Children of age groups from 18 to 24 who complete the basic immunization (3 doses) and do not strengthen the immunization according to the immunization planning program;
4. Infants of the age of March who were not vaccinated with one hundred whitening components, 13-valent pneumonia polysaccharide-binding vaccine and Hib vaccine;
5. Obtain the informed consent from the subject's legal guardian, and sign the informed consent form;
6. The legal guardian of the subject can comply with the requirements of the clinical trial protocol;
7. The axillary body temperature of the subject was 37.0℃.

Exclusion Criteria:

1. Ablaboratory examination indicators for children aged 4 to 6, except minor abnormalities judged by doctors without clinical significance;
2. A history of pertussis, diphtheria, and tetanus;
3. Infants born with preterm birth (birth before the 37th week of gestation), abnormal labor period (dystocia, instrumental midwifery, etc.), low weight (<2500g male and <2300g female); only at 3 months of age;
4. Innate malformations or developmental disorders, genetic defects, serious malnutrition, etc.;
5. Patients with epilepsy, convulsions or convulsions, or a family history of psychosis;
6. Autoimmune diseases or immune defects, or parents or siblings have autoimmune diseases or immune defects;
7. No splenic function and defective spleen function caused by any condition;
8. Abnormal coagulation function (such as lack of coagulation factors, abnormal coagulation disease, platelet), or obvious hematoma or coagulation disorder;
9. allergic to a known component of the study vaccine or any previous history of severe allergy (extensive urticaria, angioedema, etc.);
10. Immunoglobulin and / or any blood products (except hepatitis B immunoglobulin) were given within 3 months before the enrollment;
11. Those treated with any immunoenhancement or inhibitor within 3 months (continuous oral or infusion for more than 14 days;
12. Received subunit or inactivated vaccine in the past 7 days, and received live attenuated vaccine in the past 14 days;
13. Acute attacks of various acute diseases or chronic diseases in the past 7 days;
14. According to the investigator, the subject had any other factors not suitable to participate in the clinical trial.

The 2 and 3rd vaccination exclusion / delay criteria:

Exclusion criteria The investigator will terminate the subject vaccination trial vaccine if any of the following occurs.

1. Any newly diagnosed or suspected autoimmune disease or immunodeficiency disease issued during vaccination;
2. Other serious adverse events related to the study vaccine (including severe pain, severe swelling, severe limited restriction, persistent high fever, severe headache or other systemic or local reactions) occurred;
3. Severe allergic reaction or hypersensitivity reaction after vaccination (including severe urticaria / rash occurring within 30 minutes after vaccination);
4. The investigator evaluates any other reasons considered necessary to terminate the trial vaccination.

Delay the standard If any of the following conditions occur, the investigator will delay vaccination until the situation eases.The delay in vaccination should be kept within the specified time window (see: study flowchart).

1. Received subunit or inactivated vaccine in the past 7 days, and received live attenuated vaccine in the past 14 days;
2. At the time of vaccination, an acute disease (acute disease is a moderate or severe disease with or without fever) or a new chronic disease;
3. Physical examination of arm temperature> 37.0℃ before vaccination;
4. Other situations where the researchers believe that the vaccination should be postponed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adsorbed a cell-free whitening break (three-component) combination vaccine; A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine.	Biological: A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine; A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of the adsorbed cell-free whitening break (three-component) combination vaccine was evaluated	Adverse events within 30 minutes after vaccination of each test dose;; occurrence of solicitation adverse events within 0-7 days after vaccination of each dose;; The occurrence of non-solicitation adverse events within 0-30 days after vaccination for each test dose;; occurrence of serious adverse events 6 months after the first dose of immunization to the whole immunization.	Ten months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunimmunogenicity of the cell-free (three-component) combination vaccine was evaluated	Abnormal occurrence of laboratory test indicators on day 4 after immunization between 4 and 6 years old age groups;; Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with the cell-free whitening break (three components) for 30 days after the full basal immunization in the 3-month age group;; Geometrical mean concentration (GMC) or geometric mean titer (GMT) of the cell-free leucocyte (three components) at 30 days after 18 to 24 months of age immunization.	Ten months

Collaborators and Investigators

• Sponsor: Changchun BCHT Biotechnology Co.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: January 8, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 8, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B1004-F20210801

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