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Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

NCT07112144 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1650

Last updated 2025-08-08

No results posted yet for this study

Summary

The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.

Conditions

  • Prevent Whooping Cough
  • Prevent Diphtheria
  • Prevent Tetanus

Interventions

BIOLOGICAL

DTacP

Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml；Injection；

BIOLOGICAL

DTaP

Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml.Injection

BIOLOGICAL

DTacP-IPV/Hib

Administer 1 dose at 2 months, 4 months, 6 months and 18 months of age respectively, with each injection dose being 0.5 ml.Injection

Sponsors & Collaborators

  • Yunnan Provincial Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Guizhou Provincial Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Shandong Provincial Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2032-06-30
Completion
2032-06-30

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07112144 on ClinicalTrials.gov