Diphtheria, Tetanus and Acellular PertussisPhase 1NCT07203755
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
A Phase 1 study testing Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4), DTcP-Hib-MCV4 and Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) in people with Diphtheria, Tetanus and Acellular Pertussis and Epidemic Meningitis, run by CanSino Biologics Inc. at 1 site in China.
Trial summary
This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis, Haemophilus Influenzae Type B Infection
- What is being tested?
- Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4), DTcP-Hib-MCV4 and Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to Feb 2029
- Phase
- Phase 1
- 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 2 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- General Inclusion Criteria:
- Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years of age, with legal guardians or authorized representatives willing to provide identification documentation;
- Legal guardians or authorized representatives provide informed consent, voluntarily sign the informed consent form, and are able to comply with the requirements of the clinical trial protocol;
- Part I: Specific Inclusion Criteria:
- Individuals aged 18-24 months who have completed a 3-dose DTaP-containing vaccine series and a meningococcal-containing vaccine primary series, but have not received a DTaP-containing booster dose;
- Individuals aged 6 years who have completed 4 doses of DTaP-containing vaccine but have not received the 5th DTaP-containing vaccine dose; and have only completed the first meningococcal-containing vaccine booster dose, without receiving the second meningococcal-containing vaccine booster dose at age 6.
Who cannot join
- General Exclusion Criteria for First Dose：
- Infants born prematurely (delivery before 37 weeks gestation) or with low birth weight (<2500g) at 2 months (60-89 days) or 3 months (90-119 days) of age;
- Infants aged 2 months (60-89 days) or 3 months (90-119 days) with history of abnormal labor, asphyxia requiring resuscitation, or neurological impairment;
- Severe congenital malformations or developmental disorders, genetic defects, or severe malnutrition;
- History of severe adverse reactions or anaphylaxis to vaccines or vaccine components, such as urticaria, dyspnea, angioedema;
- History of epilepsy, convulsions, seizures, cerebral palsy, psychiatric disorders, or family history thereof; or history of progressive neurological diseases (e.g., Guillain-Barré syndrome, brachial plexus neuritis);
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- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;
- Acute illness (e.g., fever ≥38.5°C, diarrhea) or acute exacerbation of chronic disease within 3 days prior to receiving the investigational product;
- Known or suspected severe chronic diseases (including: severe respiratory disease, severe cardiovascular disease, liver/kidney disease, severe dermatology conditions, malignancies, etc.);
- Current anal abscess or severe eczema;
- Clinically diagnosed coagulation disorders (e.g., factor deficiency, bleeding disorders, platelet abnormalities) or significant bruising/coagulation impairment;
- Asplenia, functional asplenia, or splenectomy due to any cause;
- Continuous treatment with immunosuppressants, immunomodulators, or cytotoxic agents (exceeding 10 days) within the past 6 months; inhaled or topical steroids are permitted;
- Receipt of blood products or immunoglobulins (excluding hepatitis B immunoglobulin) within the past 3 months;
- Received an injectable live attenuated vaccine within 14 days, or any other vaccine within 7 days;
- Taken antipyretic analgesics or antiallergic medications within 3 days;
- Fever present prior to vaccination, with axillary temperature ≥37.3°C (99.3°F);
- Plans to participate in or is currently participating in any other drug/vaccine clinical trial;
- Any other factors deemed by the investigator to make the subject unsuitable for participation in the clinical trial.
- Part I: Exclusion Criteria for the First Dose：
- Infants aged 2 months (60-89 days) who have received vaccines containing meningococcal, DTP, or Haemophilus influenzae type b components;
- Infants aged 3 months (90-119 days) who have received a vaccine containing meningococcal components;
- Individuals aged 18-24 months who have received vaccines containing meningococcal or Haemophilus influenzae type b components within the past six months;
- Individuals aged 18-24 months with abnormal pre-vaccination blood count or urinalysis results deemed clinically significant by the investigator;
- Children aged 6 years who, prior to vaccination, exhibit abnormal results in relevant indicators of complete blood count, blood biochemistry, coagulation function, or urinalysis, and are deemed clinically significant by the investigator;
- Individuals with a history of any of the following diseases: meningococcal meningitis, Haemophilus influenzae type b disease, pertussis, diphtheria, or tetanus.
- Part II: Specific Exclusion Criteria for the First Dose
- History of vaccination with any meningococcal-containing vaccine;
- History of meningococcal disease. General Exclusion Criteria for Subsequent Doses：
- Occurrence of a serious adverse event related to vaccination following the previous dose;
- Vaccine-related Grade 3 or higher allergic reaction following the previous dose;
- Any other factors deemed by the investigator to make the subject unsuitable for continued participation 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
Liangyuan District Center for Disease Control and Prevention, Shangqiu City
Shangqiu, Henan
Qiang Liu
About this study
Official title: A Randomized, Partially Blinded, Dose-Exploratory, Active/Placebo-Controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of the Adsorbed Acellular Pertussis (Tricomponent) DPT-Hib (Conjugate)-ACYW135-Group B Meningococcal (Conjugate) Combined Vaccine in Individuals Aged 2 Months to 6 Years
This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine/placebo groups.
- Conditions
- Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis, Haemophilus Influenzae Type B Infection
- Being tested
- Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4), DTcP-Hib-MCV4, Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP), Haemophilus influenzae type b (Conjugate) (Hib), Meningococcal Group ACYW135 (Conjugate) (MCV4)
- Keywords
- Combined Vaccine, Safety, Immunogenicity, Ages 2 months to 6 years
- Medical subject headings
- Diphtheria, Tetanus, Meningitis, Meningococcal, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)Biological
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
DTcP-Hib-MCV4Biological
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
DTcP-Hib-MCV4Biological
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
DTcP-Hib-MCV4Biological
3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
DTcP-Hib-MCV4Biological
3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)Biological
3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Haemophilus influenzae type b (Conjugate) (Hib)Biological
3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Meningococcal Group ACYW135 (Conjugate) (MCV4)Biological
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
MCV4Biological
3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
MCV4Biological
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.
Sodium Chloride Injection (0.9%) (Saline Solution) (NS)Other
3 doses of NS (0.5ml) at 0, 2, and 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Part I, 1A, low dose, 6 year-old | Experimental | One dose of DTcP-Hib-MCV4 on Day 0 Receives: Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4) |
| Part I, 2A, low dose, 18~24 month-old | Experimental | One dose of DTcP-Hib-MCV4 on Day 0 Receives: Biological: DTcP-Hib-MCV4 |
| Part I, 2B, high dose, 18~24 month-old | Experimental | One dose of DTcP-Hib-MCV4 on Day 0 Receives: Biological: DTcP-Hib-MCV4 |
| Part I, 3A, low dose, 2 month-old | Experimental | 3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Receives: Biological: DTcP-Hib-MCV4 |
| Part I, 3B, high dose, 2 month-old | Experimental | 3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Receives: Biological: DTcP-Hib-MCV4 |
| Part I, 3C, 2 month-old | Active comparator | 3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Receives: Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) |
| Part I, 3D, 2 month-old | Active comparator | 3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Receives: Biological: Haemophilus influenzae type b (Conjugate) (Hib) |
| Part I, 3E, 2 month-old | Active comparator | 3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Receives: Biological: Meningococcal Group ACYW135 (Conjugate) (MCV4) |
| Part I, 4A, 3 month-old | Active comparator | 3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age. Receives: Biological: MCV4 |
| Part II, Vaccine Group, 2 month-old | Experimental | 3 doses of MCV4 at 0, 2, and 4 months. Receives: Biological: MCV4 |
| Part II, Placebo Group, 2 month-old | Placebo comparator | 3 doses of NS at 0, 2, and 4 months. Receives: Other: Sodium Chloride Injection (0.9%) (Saline Solution) (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Measured: Parts I and II: Within 14 days after each dose
Secondary outcomes (25)
Incidence of adverse events
Measured: Part I Sections 1A, 2A, 2B: Within 14 days after exemption
Incidence of adverse events
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 14 days after each dose
Incidence of adverse reactions/events
Measured: Part I Sections 1A, 2A, 2B: Within 30 minutes after exemption
Incidence of adverse reactions/events
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 minutes after each dose
Incidence of adverse reactions/events
Measured: Part I Sections 1A, 2A, 2B: Within 30 days after exemption
Incidence of adverse reactions/events
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 days after each dose
Incidence of Serious Adverse Event (SAE)
Measured: Part I Sections 1A, 2A, 2B: Within 180 days after exemption
Incidence of Adverse Event of Special Interest (AESI)
Measured: Part I Sections 1A, 2A, 2B: Within 180 days after exemption
Incidence of Serious Adverse Event (SAE)
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose
Incidence of Adverse Event of Special Interest (AESI)
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose
Abnormal laboratory test values
Measured: Part I Sections 1A, 2A, 2B: 4 days after exemption
Seroconversion Rate of A, C, Y, W135 Group Meningococcal Antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination
Geometric Mean Titer (GMT) of A, C, Y, W135 Group Meningococcal Antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Positive Rate of A, C, Y, W135 Group Meningococcal Antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Geometric mean increase (GMI) of A, C, Y, W135 Group Meningococcal Antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Proportion of individuals with ≥1:128 titers for A, C, Y, W135 Group Meningococcal Antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Seroconversion rates of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, TT antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Seropositivity rate of serum anti-PT, FHA, PRN, DT, TT antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
GMI of serum anti-PT, FHA, PRN, DT, TT antibody
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Percentage of serum anti-Hib-Polyribosyl Ribitol Phosphate (PRP) antibody concentrations ≥0.15 μg/ml
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Percentage of serum anti-Hib-PRP antibody concentrations ≥1.0 μg/ml
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
GMC of serum anti-Hib-PRP antibodies
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Seroconversion rate of serum anti-Hib-PRP antibodies
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
GMI of serum anti-Hib-PRP antibodies
Measured: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start19 Dec 2025
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diphtheria, Tetanus and Acellular PertussisStudies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203755
- Sponsor's protocol ID
- CTP-DHMCV-001
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially Blinded, Dose-Exploratory, Active/Placebo-Controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of the Adsorbed Acellular Pertussis (Tricomponent) DPT-Hib (Conjugate)-ACYW135-Group B Meningococcal (Conjugate) Combined Vaccine in Individuals Aged 2 Months to 6 Years
- ClinicalTrials.gov ID
- NCT07203755
- Acronym / sponsor ID
- CTP-DHMCV-001
- Conditions
- Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis, Haemophilus Influenzae Type B Infection
- Keywords
- Combined Vaccine, Safety, Immunogenicity, Ages 2 months to 6 years
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 2 Oct 2025 (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.
This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine/placebo groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part I, 1A, low dose, 6 year-old | Experimental | Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)One dose of DTcP-Hib-MCV4 on Day 0 |
| Part I, 2A, low dose, 18~24 month-old | Experimental | Biological: DTcP-Hib-MCV4One dose of DTcP-Hib-MCV4 on Day 0 |
| Part I, 2B, high dose, 18~24 month-old | Experimental | Biological: DTcP-Hib-MCV4One dose of DTcP-Hib-MCV4 on Day 0 |
| Part I, 3A, low dose, 2 month-old | Experimental | Biological: DTcP-Hib-MCV43 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| Part I, 3B, high dose, 2 month-old | Experimental | Biological: DTcP-Hib-MCV43 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| Part I, 3C, 2 month-old | Active comparator | Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| Part I, 3D, 2 month-old | Active comparator | Biological: Haemophilus influenzae type b (Conjugate) (Hib)3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| Part I, 3E, 2 month-old | Active comparator | Biological: Meningococcal Group ACYW135 (Conjugate) (MCV4)3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| Part I, 4A, 3 month-old | Active comparator | Biological: MCV43 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age. |
| Part II, Vaccine Group, 2 month-old | Experimental | Biological: MCV43 doses of MCV4 at 0, 2, and 4 months. |
| Part II, Placebo Group, 2 month-old | Placebo comparator | Other: Sodium Chloride Injection (0.9%) (Saline Solution) (NS)3 doses of NS at 0, 2, and 4 months. |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years of age, with legal guardians or authorized representatives willing to provide identification documentation;
- Legal guardians or authorized representatives provide informed consent, voluntarily sign the informed consent form, and are able to comply with the requirements of the clinical trial protocol;
- Individuals aged 18-24 months who have completed a 3-dose DTaP-containing vaccine series and a meningococcal-containing vaccine primary series, but have not received a DTaP-containing booster dose;
- Individuals aged 6 years who have completed 4 doses of DTaP-containing vaccine but have not received the 5th DTaP-containing vaccine dose; and have only completed the first meningococcal-containing vaccine booster dose, without receiving the second meningococcal-containing vaccine booster dose at age 6.
Key exclusion criteria (32 listed)
- General Exclusion Criteria for First Dose：
- Infants born prematurely (delivery before 37 weeks gestation) or with low birth weight (<2500g) at 2 months (60-89 days) or 3 months (90-119 days) of age;
- Infants aged 2 months (60-89 days) or 3 months (90-119 days) with history of abnormal labor, asphyxia requiring resuscitation, or neurological impairment;
- Severe congenital malformations or developmental disorders, genetic defects, or severe malnutrition;
- History of severe adverse reactions or anaphylaxis to vaccines or vaccine components, such as urticaria, dyspnea, angioedema;
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 |
|---|---|---|
| Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 | Biological | Part I, 1A, low dose, 6 year-old |
| DTcP-Hib-MCV41 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 | Biological | Part I, 2A, low dose, 18~24 month-old |
| DTcP-Hib-MCV41 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 | Biological | Part I, 2B, high dose, 18~24 month-old |
| DTcP-Hib-MCV43 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. | Biological | Part I, 3A, low dose, 2 month-old |
| DTcP-Hib-MCV43 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. | Biological | Part I, 3B, high dose, 2 month-old |
| Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. | Biological | Part I, 3C, 2 month-old |
| Haemophilus influenzae type b (Conjugate) (Hib)3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. | Biological | Part I, 3D, 2 month-old |
| Meningococcal Group ACYW135 (Conjugate) (MCV4)3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. | Biological | Part I, 3E, 2 month-old |
| MCV43 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age. | Biological | Part I, 4A, 3 month-old |
| MCV43 doses of MCV4 (0.5ml) at 0, 2, and 4 months. | Biological | Part II, Vaccine Group, 2 month-old |
| Sodium Chloride Injection (0.9%) (Saline Solution) (NS)3 doses of NS (0.5ml) at 0, 2, and 4 months. | Other | Part II, Placebo Group, 2 month-old |
Primary outcome
Incidence of adverse reactions
Time frame: Parts I and II: Within 14 days after each dose
25 secondary outcomes
Incidence of adverse events
Time frame: Part I Sections 1A, 2A, 2B: Within 14 days after exemption
Incidence of adverse events
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 14 days after each dose
Incidence of adverse reactions/events
Time frame: Part I Sections 1A, 2A, 2B: Within 30 minutes after exemption
Incidence of adverse reactions/events
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 minutes after each dose
Incidence of adverse reactions/events
Time frame: Part I Sections 1A, 2A, 2B: Within 30 days after exemption
Incidence of adverse reactions/events
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 days after each dose
Incidence of Serious Adverse Event (SAE)
Time frame: Part I Sections 1A, 2A, 2B: Within 180 days after exemption
Incidence of Adverse Event of Special Interest (AESI)
Time frame: Part I Sections 1A, 2A, 2B: Within 180 days after exemption
Incidence of Serious Adverse Event (SAE)
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose
Incidence of Adverse Event of Special Interest (AESI)
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose
Abnormal laboratory test values
Time frame: Part I Sections 1A, 2A, 2B: 4 days after exemption
Seroconversion Rate of A, C, Y, W135 Group Meningococcal Antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination
Geometric Mean Titer (GMT) of A, C, Y, W135 Group Meningococcal Antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Positive Rate of A, C, Y, W135 Group Meningococcal Antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Geometric mean increase (GMI) of A, C, Y, W135 Group Meningococcal Antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Proportion of individuals with ≥1:128 titers for A, C, Y, W135 Group Meningococcal Antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Seroconversion rates of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, TT antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Seropositivity rate of serum anti-PT, FHA, PRN, DT, TT antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
GMI of serum anti-PT, FHA, PRN, DT, TT antibody
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Percentage of serum anti-Hib-Polyribosyl Ribitol Phosphate (PRP) antibody concentrations ≥0.15 μg/ml
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Percentage of serum anti-Hib-PRP antibody concentrations ≥1.0 μg/ml
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
GMC of serum anti-Hib-PRP antibodies
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
Seroconversion rate of serum anti-Hib-PRP antibodies
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
GMI of serum anti-Hib-PRP antibodies
Time frame: Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3
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 31 Dec 2025.
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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.
Yanxia Wang principal investigator
Henan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4), DTcP-Hib-MCV4 and Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) in people with Diphtheria, Tetanus and Acellular Pertussis and Epidemic Meningitis, run by CanSino Biologics Inc. 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 6 inclusion and 32 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 31 Dec 2025. 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. Some participants in this study may receive a placebo. 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 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.
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 Ying Wang (022-58213600-6051, ying.wang@cansinotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: Parts I and II: Within 14 days after each dose). 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 31 Dec 2025.