Actively Recruiting
A Randomized, Partially Blinded, Dose-Exploratory, Active/Placebo-Controlled Clinical Trial Evaluating Safety and Immune Response of the Combined DTcP-Hib-MCV4 Vaccine in Children Aged 2 Months to 6 Years
Led by CanSino Biologics Inc. · Updated on 2025-12-31
260
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of a combined vaccine that includes components for Diphtheria, Tetanus, Acellular Pertussis, Haemophilus influenzae type b, and Meningococcal group ACYW135 in children aged 2 months to 6 years. This Phase I clinical trial includes two parts: Part One uses a randomized, partially blinded, dose-escalation and partially active-controlled design, while Part Two is a randomized, blinded, placebo-controlled study focusing on 2-month-old participants. The study involves multiple vaccine dosing schedules depending on the participant's age group. Some groups receive a single dose of the combined vaccine on Day 0, while others receive three doses at 0, 2, and 4 months, followed by a booster dose between 18 and 24 months of age. The trial compares different dose levels, age groups, and also includes active comparator vaccines and placebo groups. Participants will undergo monitoring for adverse reactions within 14 days after each dose, with additional safety assessments extending up to 180 days for serious events. Researchers will evaluate immune responses by measuring specific antibodies against meningococcal groups and other vaccine components at various timepoints, including before and after booster doses. The total participation duration and detailed follow-up visits are designed to assess both safety and immunogenicity comprehensively.
CONDITIONS
Brief Title
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years of age
- Legal guardians or authorized representatives must provide informed consent and identification
- Children aged 18-24 months must have completed a 3-dose DTaP and meningococcal vaccine series without a DTaP booster
- Children aged 6 years must have completed 4 DTaP doses and one meningococcal booster but not the second meningococcal booster
- Ability to comply with study protocol requirements
You will not qualify if you...
- Infants born prematurely before 37 weeks gestation or with low birth weight (<2500g) at 2 or 3 months of age
- History of abnormal labor, asphyxia requiring resuscitation, or neurological impairment in infants 2 or 3 months old
- Severe congenital malformations, developmental disorders, genetic defects, or severe malnutrition
- Severe allergic reactions or anaphylaxis to vaccines or components
- History of epilepsy, seizures, cerebral palsy, psychiatric or progressive neurological diseases
- Diagnosed immunodeficiency, HIV, lymphoma, leukemia, autoimmune diseases such as lupus or juvenile rheumatoid arthritis
- Acute illness or exacerbation of chronic disease within 3 days before vaccination
- Severe chronic diseases including respiratory, cardiovascular, liver, kidney, skin conditions, or malignancies
- Current anal abscess or severe eczema
- Blood clotting disorders or significant bruising
- Asplenia or splenectomy
- Immunosuppressive treatment exceeding 10 days in past 6 months (except inhaled or topical steroids)
- Recent receipt of blood products or immunoglobulins within 3 months
- Recent live attenuated vaccine within 14 days or any other vaccine within 7 days
- Use of antipyretic or antiallergic medications within 3 days
- Fever with axillary temperature ≥37.3°C before vaccination
- Participation in other drug/vaccine clinical trials
- History of meningococcal, Haemophilus influenzae type b, pertussis, diphtheria, or tetanus diseases
- Abnormal clinical lab results deemed significant by investigators
- Serious adverse events or severe allergic reactions related to previous vaccine doses
- Any other investigator-determined factors making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 24 months
Participants receive 3 doses of the combined DTcP-Hib-MCV4 vaccine at 0, 2, and 4 months, followed by a booster dose at 18 to 24 months of age.
4 vaccination visits over 24 months
Duration - Up to 6 months after booster dose
Participants are monitored for safety and immune response for up to 180 days after the first dose through the booster dose.
Regular visits for safety and immune response assessments during and after vaccination
Trial Site Locations
Total: 1 location
1
Liangyuan District Center for Disease Control and Prevention, Shangqiu City
Shangqiu, Henan, China
Actively Recruiting
Research Team
Y
Ying Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
11
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