Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Diphtheria, Tetanus and Acellular Pertussis, Epidemic Meningitis, Haemophilus Influenzae Type B Infection

In brief

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.

Key facts

Study ID

NCT07203755

Run by

CanSino Biologics Inc.

People needed

260

Starts

2025-12-19

Expected to finish

2029-02-01

Last updated by the study team

2025-12-31

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify 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) 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 the investigator;

Where it is running

• Liangyuan District Center for Disease Control and Prevention, Shangqiu City — Shangqiu, Henan, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.