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

NCT07203755 | Recruiting Phase 1 DMC

• 1 other identifier: CTP-DHMCV-001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diphtheria, Tetanus and Acellular Pertussis; Haemophilus Influenzae Type B Infection; Epidemic Meningitis

Keywords

Combined Vaccine; Safety; Immunogenicity; Ages 2 months to 6 years

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

  Parts I and II: Within 14 days after each dose

Secondary Outcomes (25)

• Incidence of adverse events

  Part I Sections 1A, 2A, 2B: Within 14 days after exemption

• Incidence of adverse events

  Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 14 days after each dose

• Incidence of adverse reactions/events

  Part I Sections 1A, 2A, 2B: Within 30 minutes after exemption

• Incidence of adverse reactions/events

  Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 minutes after each dose

• Incidence of adverse reactions/events

  Part I Sections 1A, 2A, 2B: Within 30 days after exemption

Study Arms (11)

Part I, 1A, low dose, 6 year-old

EXPERIMENTAL

One dose of DTcP-Hib-MCV4 on Day 0

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

Part I, 2A, low dose, 18~24 month-old

EXPERIMENTAL

One dose of DTcP-Hib-MCV4 on Day 0

Biological: DTcP-Hib-MCV4

Part I, 2B, high dose, 18~24 month-old

EXPERIMENTAL

One dose of DTcP-Hib-MCV4 on Day 0

Biological: DTcP-Hib-MCV4

Part I, 3A, low dose, 2 month-old

EXPERIMENTAL

3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

Biological: DTcP-Hib-MCV4

Part I, 3B, high dose, 2 month-old

EXPERIMENTAL

3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

Biological: DTcP-Hib-MCV4

Part I, 3C, 2 month-old

ACTIVE COMPARATOR

3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

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

Part I, 3D, 2 month-old

ACTIVE COMPARATOR

3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

Biological: Haemophilus influenzae type b (Conjugate) (Hib)

Part I, 3E, 2 month-old

ACTIVE COMPARATOR

3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

Biological: Meningococcal Group ACYW135 (Conjugate) (MCV4)

Part I, 4A, 3 month-old

ACTIVE COMPARATOR

3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age.

Biological: MCV4

Part II, Vaccine Group, 2 month-old

EXPERIMENTAL

3 doses of MCV4 at 0, 2, and 4 months.

Biological: MCV4

Part II, Placebo Group, 2 month-old

PLACEBO COMPARATOR

3 doses of NS at 0, 2, and 4 months.

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

Interventions

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

1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0

Part I, 1A, low dose, 6 year-old

DTcP-Hib-MCV4 BIOLOGICAL

1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0

Part I, 2A, low dose, 18~24 month-old

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

3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

Part I, 3C, 2 month-old

Haemophilus influenzae type b (Conjugate) (Hib) BIOLOGICAL

3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

Part I, 3D, 2 month-old

Meningococcal Group ACYW135 (Conjugate) (MCV4) BIOLOGICAL

3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.

Part I, 3E, 2 month-old

MCV4 BIOLOGICAL

3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.

Part I, 4A, 3 month-old

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

3 doses of NS (0.5ml) at 0, 2, and 4 months.

Part II, Placebo Group, 2 month-old

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Liangyuan District Center for Disease Control and Prevention, Shangqiu City

Shangqiu, Henan, China

RECRUITING

MeSH Terms

Conditions

Diphtheria; Tetanus; Meningitis, Meningococcal; Haemophilus Infections

Interventions

Vaccines, Combined; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yanxia Wang

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part One: Partial Blind Method Design Part Two: Blind Method Design
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 2, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-09

Locations

CN (1)