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

RECRUITINGPHASE1

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

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

NCT07203755•CanSino Biologics Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 6 years

Sex

ALL

Healthy Volunteers

Yes

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;
•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

•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;
+18 more criteria

Locations (1)

Liangyuan District Center for Disease Control and Prevention, Shangqiu City

Shangqiu, Henan, China

Key Dates

Start Date

December 19, 2025

Primary Completion Date

February 1, 2029

Completion Date

February 1, 2029

Last Updated

December 31, 2025

Enrollment

260

ESTIMATED participants

Conditions

Diphtheria, Tetanus and Acellular PertussisEpidemic MeningitisHaemophilus Influenzae Type B Infection

Interventions

Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)

BIOLOGICAL

DTcP-Hib-MCV4

BIOLOGICAL

DTcP-Hib-MCV4

BIOLOGICAL

DTcP-Hib-MCV4

BIOLOGICAL

DTcP-Hib-MCV4

BIOLOGICAL

Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)

BIOLOGICAL

Haemophilus influenzae type b (Conjugate) (Hib)

BIOLOGICAL

Meningococcal Group ACYW135 (Conjugate) (MCV4)

BIOLOGICAL

MCV4

BIOLOGICAL

MCV4

BIOLOGICAL

Sodium Chloride Injection (0.9%) (Saline Solution) (NS)

OTHER

Contacts

Ying Wang

CONTACT

022-58213600-6051 ying.wang@cansinotech.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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