Safety、ImmunogenicityPhase 1/2NCT05189548
To Evaluate the Safety and Primary Immunogenicity of Cell-free (Three-component) Combination Vaccine for Phase I Immunogenicity in Children and Infants
A Phase 1/2 study testing 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 in people with Safety、Immunogenicity, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety、Immunogenicity
- What is being tested?
- 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
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 30 Sep 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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℃.
Who cannot join
- 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;
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- 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.
- 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.
- Any newly diagnosed or suspected autoimmune disease or immunodeficiency disease issued during vaccination;
- 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;
- Severe allergic reaction or hypersensitivity reaction after vaccination (including severe urticaria / rash occurring within 30 minutes after vaccination);
- 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).
- Received subunit or inactivated vaccine in the past 7 days, and received live attenuated vaccine in the past 14 days;
- 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;
- Physical examination of arm temperature> 37.0℃ before vaccination;
- Other situations where the researchers believe that the vaccination should be postponed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Santai County Center for Disease Control and Prevention
Mianyang, Sichuan, 621100
Yulin Jing
About this study
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.
Read the detailed description
Main endpoint:
- 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.
Secondary endpoint:
- 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 each antibody combined with cell-free leucocyte (three-component) adsorption at 30 days after 18 to 24 months of age immunization.
- Conditions
- Safety、Immunogenicity
- Being tested
- 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 participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 vaccineBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ten months
Secondary outcomes (1)
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.
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Dec 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety、ImmunogenicityStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189548
- Sponsor's protocol ID
- B1004-F20210801
- Status last verified
- Nov 2021
- First submitted
- 1 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Primary Immunogenicity of Cell-free (Three-component) Combination Vaccine for Phase I Immunogenicity in Children and Infants
- ClinicalTrials.gov ID
- NCT05189548
- Acronym / sponsor ID
- B1004-F20210801
- Conditions
- Safety、Immunogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main endpoint:
- 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.
Secondary endpoint:
- 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 each antibody combined with cell-free leucocyte (three-component) adsorption at 30 days after 18 to 24 months of age immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adsorbed a cell-free whitening break (three-component) combination vaccine | Experimental | 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 vaccineA 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. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 vaccineA 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 | Adsorbed a cell-free whitening break (three-component) combination vaccine |
Primary outcome
The safety of the adsorbed cell-free whitening break (three-component) combination vaccine was evaluated
Time frame: Ten months
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.
1 secondary outcome
Immunimmunogenicity of the cell-free (three-component) combination vaccine was evaluated
Time frame: Ten months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 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 in people with Safety、Immunogenicity, run by Changchun BCHT Biotechnology Co. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Zhu (0852-85596863, xiaopingzhu98@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of the adsorbed cell-free whitening break (three-component) combination vaccine was evaluated (time frame: Ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.