A Phase 1 interventional study of Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4) and DTcP-Hib-MCV4 in Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis and Haemophilus Influenzae Type B Infection, sponsored by CanSino Biologics Inc.. Recruiting at 1 site in China. Open to participants aged 2 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by CanSino Biologics Inc. · Phase 1, Interventional, and Prevention
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.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's planned enrollment of 260 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →CanSino Biologics Inc. is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General Inclusion Criteria:
Part I: Specific Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria for First Dose：
Part I: Exclusion Criteria for the First Dose：
Part II: Specific Exclusion Criteria for the First Dose
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One dose of DTcP-Hib-MCV4 on Day 0
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
Biological: DTcP-Hib-MCV4
One dose of DTcP-Hib-MCV4 on Day 0
Biological: DTcP-Hib-MCV4
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Biological: DTcP-Hib-MCV4
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Biological: DTcP-Hib-MCV4
3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)
3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Biological: Haemophilus influenzae type b (Conjugate) (Hib)
3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
Biological: Meningococcal Group ACYW135 (Conjugate) (MCV4)
3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
Biological: MCV4
3 doses of MCV4 at 0, 2, and 4 months.
Biological: MCV4
3 doses of NS at 0, 2, and 4 months.
Other: Sodium Chloride Injection (0.9%) (Saline Solution) (NS)
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
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.
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.
3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.
3 doses of NS (0.5ml) at 0, 2, and 4 months.
Incidence of adverse reactions
Time frame: Parts I and II: Within 14 days after each dose
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
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