Actively Recruiting

Phase 3
Age: 2Months - 3Months
All Genders
Healthy Volunteers
NCT07112144

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

Led by Changchun BCHT Biotechnology Co. · Updated on 2025-08-08

1650

Participants Needed

1

Research Sites

363 weeks

Total Duration

On this page

Sponsors

C

Changchun BCHT Biotechnology Co.

Lead Sponsor

Y

Yunnan Provincial Center for Disease Control and Prevention

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Months - 3Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy infants and young children aged 2 months (60-89 days) who are permanent residents and can provide valid ID for themselves and their legal guardian
  • Legal guardian provides informed consent and signs consent form
  • Legal guardian can follow the clinical trial protocol requirements
Not Eligible

You will not qualify if you...

  • History of pertussis, diphtheria, or tetanus
  • Contact with someone diagnosed with pertussis or diphtheria in the past 30 days
  • Prior vaccination with vaccines containing DTaP components, inactivated poliovirus vaccine, 13-valent pneumococcal conjugate vaccine, or Hib vaccine
  • Premature birth before 37 weeks, severe abnormal labor, history of asphyxia rescue, or birth weight less than 2500g
  • Axillary temperature above 37.0°C on enrollment day
  • Severe congenital malformations, developmental disorders, genetic defects, severe malnutrition, or congenital diseases such as Down syndrome or sickle cell anemia
  • History of epilepsy, convulsions, seizures, cerebral palsy, or family history of mental illness
  • Autoimmune diseases or immunodeficiencies in the child or immediate family
  • Asplenia or splenic dysfunction
  • Clinically diagnosed coagulation disorders or bruising that contraindicates intramuscular injection
  • History of severe allergic diseases or reactions to vaccines or vaccine components
  • Vaccination with subunit or inactivated vaccines within 7 days or live vaccines within 14 days prior
  • Receipt of immunoglobulin or blood products (except hepatitis B immunoglobulin) before enrollment
  • Immunostimulant or immunosuppressant therapy before enrollment exceeding specified durations or dosages
  • Acute moderate or severe illness within 3 days before enrollment
  • Use of prophylactic medications within 3 days before enrollment
  • Severe clinically diagnosed diseases affecting major body systems or history of malignant tumors
  • Current participation or planned participation in other clinical trials during the study period
  • Other factors judged by researchers as unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Yanshan County Center for Disease Control and Prevention

Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan, China, 663100

Actively Recruiting

Loading map...

Research Team

H

huan xiao li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here