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Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants

Pertussis Clinical Trial

Official title:
Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy Infants 3 to 5 Months of Age: A Randomized, Blinded, Single-center, Positive Controlled Clinical Trial

Clinical Trial Summary

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may cause more side reactions after vaccination. Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American. In 1995, DTaP was successfully developed in China, and have been used in EPI at present. Because of effective immunity and little side reaction, DTaP has been widely recognized and accepted by the parents.

Clinical Trial Description

Pertussis, diphtheria and tetanus are seriously infectious diseases for children. The world health organization (WHO) included the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP) into the expanded program on immunization (EPI), as a basic immunization. Since using the DTwP, it greatly reduced incidence of the three kinds of diseases. Thousands of children have been saved since its application. Although the DTwP was productively in against pertussis, diphtheria and tetanus, thallus of pertussis in the vaccine could cause more side reactions after vaccination. Many individuals did not want to be vaccinated. However, there was two large epidemics of pertussis during the period of 1977-1979 and 1981-1983. Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine (DTaP) vaccine in American. In 1995, DTaP was successful developed in the investigators' country, and is used in EPI at present. Because of effective immunity and causing little side reaction, DTaP has been widely recognized and accepted by the parents. This clinical trial is planning to evaluate the immunogenicity and safety of DTaP in 3-5 months infants . ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02477995
Study type Interventional
Source Jiangsu Province Centers for Disease Control and Prevention
Contact
Status Completed
Phase Phase 3
Start date December 2013
Completion date July 2014
View Details
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