Combined DTaP-Hib and Meningococcal ACYW135 vaccine for infants and children

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 trial tests a combined vaccine that protects against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and meningococcal ACYW135 in children aged 2 months to 6 years to see if it is safe and prompts an immune response.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 2 Months to 6 Years
• Sex: All
• Sponsor: CanSino Biologics Inc. (Industry-sponsored)
• Locations: 1 site (Shangqiu, Henan)
• Trial ID: NCT07203755 on ClinicalTrials.gov

What this trial studies

This Phase 1 trial is being done in two parts to examine safety and immune responses to a combined DTaP-Hib-MCV4 (MenACWY) vaccine in young children. Part One uses a randomized, partially blinded, dose-escalation design with partial active control and is split into four stages by age and dose level (2 months, 3 months, 18–24 months, and 6 years). Part Two is randomized and blinded with a placebo control and focuses on the 2-month-old vaccine/placebo groups. The trial is sponsored by CanSino Biologics and carried out at a local CDC site in Shangqiu, Henan, China.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 months, 3 months, 18–24 months, or 6 years who meet the age- and prior-vaccination requirements and whose legal guardian can provide informed consent and attend study visits.

Not a fit: Children with contraindications such as known severe allergy to vaccine components, significant immunodeficiency, or those outside the specified age or prior-vaccination windows are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combined vaccine could reduce the number of injections and simplify routine immunization by protecting against several diseases with a single shot.

How similar studies have performed: Combination DTaP-Hib vaccines have been used previously, but combining DTaP-Hib with a meningococcal ACYW135 conjugate in a single product is less tested and represents a newer approach.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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;
* 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.

Where this trial is running

Shangqiu, Henan

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

Study contacts

• Principal investigator: Yanxia Wang — Henan Center for Disease Control and Prevention
• Study coordinator: Ying Wang

Conditions Diphtheria, Tetanus and Acellular Pertussis; Epidemic Meningitis; Haemophilus Influenzae Type B Infection; Combined Vaccine; Safety; Immunogenicity; Ages 2 months to 6 years