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Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .

NCT04099303 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-10-31

No results posted yet for this study

Summary

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis

Interventions

BIOLOGICAL

Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

0.5 mL, Intramuscular Other Name: DTcP

BIOLOGICAL

Diphtheria and Tetanus Combined Vaccine, Adsorbed

2mL, Intramuscular Other Name: DT

BIOLOGICAL

Diphtheria-tetanus-acellular pertussis vaccine

0.5 mL, Intramuscular Other Name: DTaP

BIOLOGICAL

Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

0.5 mL, Intramuscular Other Name: PENTAXIM

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Wang Yanxia · Henan Province 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
2020-04-28
Primary Completion
2021-10-27
Completion
2021-11-25

Countries

  • China

Study Locations

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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 NCT04099303 on ClinicalTrials.gov