Healthy VolunteersPhase 3NCT06344065
Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
A Phase 3 study testing Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) and Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants. Read more about this study
- Who is it for?
- Ages 3 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) and Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,584 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2023to 25 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Basic immune stage:
- 3-month-old infants who can provide valid identification documents;
- Infants should be born following a 37-42 weeks of pregnancy and have a birth weight that meets the standard (2500g ≤ body weight ≤ 4500g);
- The legal guardian of the subject voluntarily agrees to their child's participation in the trial and signs a written informed consent form;
- The legal guardian of the subject has the ability to understand the trial procedure and participate in all planned follow-up visits;
- Has not received a vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine;
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- Active control group 2 has not been vaccinated with any vaccine containing the active ingredients of poliomyelitis vaccine or haemophilus influenzae vaccine;
- Enhanced immunity stage:
- Infants and young children aged 18-24 months who have been enrolled in this clinical trial at the age of 3 months;
- Basic immunization has been completed in this clinical trial;
- According to the researcher's opinion, the subjects and their legal guardians are able to comply with the requirements of the clinical trial protocol.
Who cannot join
- Basic immune stage:
- Has a history of pertussis, diphtheria, or tetanus;
- Has any history of severe allergies to vaccination in the past;
- Allergy to any component of the experimental vaccine;
- Has a history or family history of epilepsy, convulsions, encephalopathy, mental illness;
- Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
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- Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the trial including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart disease, liver disease, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, congenital or acquired immune defects (repeated perianal abscess), etc;
- Has the history of severe abnormal production process, suffocation rescue, neurological damage, and current pathological jaundice;
- Suffering from infectious diseases with clinical or serological evidence, such as tuberculosis, hepatitis B, hepatitis C, or HIV infection confirmed by parents;
- Within 3 months before to enrollment, has received systemic corticosteroid treatment (any route of administration, ≥ 2mg/kg/day) for ≥ 14 days, such as prednisone, inhaled steroids such as budesonide, and fluticasone; Or being using other immunosuppressants such as cyclosporine, tacrolimus, etc. before enrollment;
- Within 3 months before enrollment，has received treatment with immunoglobulin and/or any blood products (except hepatitis B immunoglobulin) ;
- Participating in or planning to participate in clinical trials of other drugs in the near future;
- According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial.
- Enhanced immunity stage:
- Newly discovered severe allergic history to any previous vaccination;
- Individuals with thrombocytopenia, any coagulation dysfunction, or undergoing anticoagulant therapy that may cause contraindications for subcutaneous injection;
- Suffering from serious congenital malformations or serious diseases that may interfere with the conduct or completion of the test, including but not limited to: infant wheezing, Down syndrome, severe thalassemia, heart disease, liver disease, kidney disease, diabetes, hereditary allergies, Guillain Barre syndrome, severe skin diseases, congenital or acquired immune defects (repeated perianal abscess), etc;
- After completing basic immunization, subjects were vaccinated with other vaccine containing the active ingredients of pertussis, diphtheria, tetanus combined vaccine before booster immunization;
- Participating in or planning to participate in clinical trials of other drugs in the near future;
- According to the researcher's judgment, there are any other factors that are not suitable for the subjects to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, 530028
Yi Mo, +86-13788686968, 13647272@qq.com
About this study
Official title: A Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial to Evaluate the Immunogenicity and Safety of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old Infants
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
Read the detailed description
This is a Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the safety and immunogenicity of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old infants. Expected to include 1584 3-month-old infants. Among them, 1056 infants were randomly assigned to the experimental group and active control group 1, and 528 infants were included in active control group 2. Select the top 200 subjects with study numbers from the experimental group as immunological persistence follow-up subset.
- Conditions
- Healthy Volunteers
- Being tested
- Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed), Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine
- Keywords
- DTaP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed)Biological
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for experimental vaccine is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.
Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed)Biological
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 1 is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccineBiological
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 2 is through intramuscular injection of 0.5ml into the anterolateral side of the thigh or the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| DTaP vaccine | Experimental | Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), 0.5ml/vial, injection. Receives: Biological: Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed) |
| Active comparator 1: DTaP vaccine | Active comparator | Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed), 0.5ml/tube; injection. Receives: Biological: Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) |
| Active comparator 2: DTaP-IPV//PRP-T vaccine | Active comparator | Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine, 0.5ml/tube; injection. Receives: Biological: Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity results of experimental group and active control group (DTaP)
Positive conversion rate (4-fold increase) of antibodies against diphtheria (anti D) and tetanus (anti T)
Measured: 30 days after basic immunization
Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T)
Positive conversion rate (4-fold increase) of pertussis toxin antibody (anti PT), pertussis filamentous hemagglutinin antibody (anti FHA) antibodies
Measured: 30 days after basic immunization
Immunogenicity results of experimental group
Positive conversion rate of pertussis adhesin antibody (anti PRN)
Measured: 30 days after basic immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start21 Dec 2023
- Primary completion25 May 2025 (estimated)
- Study completion25 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344065
- Sponsor's protocol ID
- 20220102C
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial to Evaluate the Immunogenicity and Safety of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old Infants
- ClinicalTrials.gov ID
- NCT06344065
- Acronym / sponsor ID
- 20220102C
- Conditions
- Healthy Volunteers
- Keywords
- DTaP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,584 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 3 Apr 2024 (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.
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
Detailed description
This is a Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the safety and immunogenicity of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old infants. Expected to include 1584 3-month-old infants. Among them, 1056 infants were randomly assigned to the experimental group and active control group 1, and 528 infants were included in active control group 2. Select the top 200 subjects with study numbers from the experimental group as immunological persistence follow-up subset.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DTaP vaccine | Experimental | Biological: Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed)Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), 0.5ml/vial, injection. |
| Active comparator 1: DTaP vaccine | Active comparator | Biological: Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed)Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed), 0.5ml/tube; injection. |
| Active comparator 2: DTaP-IPV//PRP-T vaccine | Active comparator | Biological: Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccineDiphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine, 0.5ml/tube; injection. |
Who may qualify
- Ages
- 3 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Basic immune stage:
- Enhanced immunity stage:
Key exclusion criteria (20 listed)
- Basic immune stage:
- Enhanced immunity stage:
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 |
|---|---|---|
| Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed)Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for experimental vaccine is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm. | Biological | DTaP vaccine |
| Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed)Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 1 is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm. | Biological | Active comparator 1: DTaP vaccine |
| Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccineThree doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 2 is through intramuscular injection of 0.5ml into the anterolateral side of the thigh or the upper arm. | Biological | Active comparator 2: DTaP-IPV//PRP-T vaccine |
Primary outcome
Immunogenicity results of experimental group and active control group (DTaP)
Time frame: 30 days after basic immunization
Positive conversion rate (4-fold increase) of antibodies against diphtheria (anti D) and tetanus (anti T)
Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T)
Time frame: 30 days after basic immunization
Positive conversion rate (4-fold increase) of pertussis toxin antibody (anti PT), pertussis filamentous hemagglutinin antibody (anti FHA) antibodies
Immunogenicity results of experimental group
Time frame: 30 days after basic immunization
Positive conversion rate of pertussis adhesin antibody (anti PRN)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Screening Protocol
Pain
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.
Lin Du study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) and Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd 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 11 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 3 Apr 2024. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjian Fang (+86-18611630252, fangwenjian@zhifeishengwu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity results of experimental group and active control group (DTaP) (time frame: 30 days after basic immunization). The study lists 3 primary outcomes in all. 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 3 Apr 2024.