Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine

Summary

This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.

Conditions

• Diphtheria
• Tetanus
• Pertussis

Interventions

BIOLOGICAL

DTacP (one-dose booster)

Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on Day 0

BIOLOGICAL

DTacP (three-dose primary vaccination)

Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine of 0.5mL on the M3-M4-M5, M2-M3-M4, or M2-M4-M6 immunization schedule

BIOLOGICAL

DT (one-dose booster)

Diphtheria-Tetanus Combined Vaccine of 0.5mL on Day 0

BIOLOGICAL

DTaP (one-dose booster)

Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on Day 0

BIOLOGICAL

PENTAXIM (one-dose booster)

Diphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on Day 0

BIOLOGICAL

DTaP (three-dose primary vaccination)

Diphtheria-Tetanus-acellular Pertussis Vaccine of 0.5mL on an M3-M4-M5immunization schedule

BIOLOGICAL

PENTAXIM (three-dose primary vaccination)

Diphtheria, Tetanus, acellular Pertussis, inactivated Polio, conjugate Haemophilus influenzae type b Combined Vaccine of 0.5mL on the M3-M4-M5 or M2-M3-M4 immunization schedule

Sponsors & Collaborators

• Sichuan Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Institute of Medical Biology, Chinese Academy of Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

2 Months

Max Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-23

Primary Completion

2024-12-15

Completion

2026-11-01

Countries

• China

Study Locations