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

NCT05189548 | Unknown Phase 1 DMC

• 1 other identifier: B1004-F20210801
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety、Immunogenicity

Outcome Measures

Primary Outcomes (1)

• The safety of the adsorbed cell-free whitening break (three-component) combination vaccine was evaluated

  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.

  Ten months

Secondary Outcomes (1)

• Immunimmunogenicity of the cell-free (three-component) combination vaccine was evaluated

  Ten months

Study Arms (1)

Adsorbed a cell-free whitening break (three-component) combination vaccine

EXPERIMENTAL

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

Interventions

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

Adsorbed a cell-free whitening break (three-component) combination vaccine

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Permanent and healthy people aged 4-6 years old, 18-24 years old, and March age group (90-119 days);
• 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;
• 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;
• Infants of the age of March who were not vaccinated with one hundred whitening components, 13-valent pneumonia polysaccharide-binding vaccine and Hib vaccine;
• Obtain the informed consent from the subject's legal guardian, and sign the informed consent form;
• The legal guardian of the subject can comply with the requirements of the clinical trial protocol;
• The axillary body temperature of the subject was 37.0℃.

You may not qualify if:

• Ablaboratory examination indicators for children aged 4 to 6, except minor abnormalities judged by doctors without clinical significance;
• A history of pertussis, diphtheria, and tetanus;
• 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;
• Innate malformations or developmental disorders, genetic defects, serious malnutrition, etc.;
• Patients with epilepsy, convulsions or convulsions, or a family history of psychosis;
• Autoimmune diseases or immune defects, or parents or siblings have autoimmune diseases or immune defects;
• No splenic function and defective spleen function caused by any condition;
• Abnormal coagulation function (such as lack of coagulation factors, abnormal coagulation disease, platelet), or obvious hematoma or coagulation disorder;
• allergic to a known component of the study vaccine or any previous history of severe allergy (extensive urticaria, angioedema, etc.);
• Immunoglobulin and / or any blood products (except hepatitis B immunoglobulin) were given within 3 months before the enrollment;
• Those treated with any immunoenhancement or inhibitor within 3 months (continuous oral or infusion for more than 14 days;
• Received subunit or inactivated vaccine in the past 7 days, and received live attenuated vaccine in the past 14 days;
• Acute attacks of various acute diseases or chronic diseases in the past 7 days;
• According to the investigator, the subject had any other factors not suitable to participate in the clinical trial.
• Any newly diagnosed or suspected autoimmune disease or immunodeficiency disease issued during vaccination;

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead

Study Sites (1)

Santai County Center for Disease Control and Prevention

Mianyang, Sichuan, 621100, China

RECRUITING

MeSH Terms

Interventions

Vaccines, Combined

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Xiaoping Zhu

CONTACT

0852-85596863; xiaopingzhu98@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 12, 2022
• Study Start: December 10, 2021
• Primary Completion: April 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 12, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)