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New treatment option for Diphtheria, Tetanus and Acellular Pertussis
Official title Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
ClinicalTrials.gov ID: NCT07203755
What this study is testing
What is Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)?
Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4) is an investigational medicine, being studied as a potential treatment for diphtheria, tetanus and acellular pertussis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 6. Healthy volunteers may be eligible.
You may be able to join if
- General
- 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...
- Legal guardians or authorized representatives provide informed consent, voluntarily sign the informed consent form, and are able to comply with the...
- Individuals aged 18-24 months who have completed a 3-dose DTaP-containing vaccine series and a meningococcal-containing vaccine primary series, but...
- 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...
You likely can't join if
- 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)...
- Infants aged 2 months (60-89 days) or 3 months (90-119 days) with history of abnormal labor, asphyxia requiring resuscitation, or neurological...
- 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...
See the full eligibility criteria
- General
- 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
- 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...
- 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);
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shangqiu, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months to 6 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shangqiu, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.