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

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
• Epidemic Meningitis
• Haemophilus Influenzae Type B Infection

Interventions

BIOLOGICAL

Meningococcal Group ACYW135 (Conjugate) (MCV4)

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

BIOLOGICAL

MCV4

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

BIOLOGICAL

MCV4

3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.

OTHER

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

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

BIOLOGICAL

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

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

BIOLOGICAL

DTcP-Hib-MCV4

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

BIOLOGICAL

DTcP-Hib-MCV4

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

BIOLOGICAL

DTcP-Hib-MCV4

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

BIOLOGICAL

DTcP-Hib-MCV4

3 doses of DTcP-Hib-MCV4 (0.5ml) 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)

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

BIOLOGICAL

Haemophilus influenzae type b (Conjugate) (Hib)

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

Sponsors & Collaborators

• CanSino Biologics Inc.

  lead INDUSTRY

Principal Investigators

• Yanxia Wang · Henan Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-19

Primary Completion

2029-02-28

Completion

2029-02-28

Countries

• China

Study Locations