Skip to main content
OpenTrials
Completed

NCT Number: NCT04099303

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Changge Center for Disease Control and Prevention

Xuchang, Henan, 461500, China

About this study

Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post vaccination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects aged 2months、3months、18-24months and 4-6 years old;
  • Willing to provide proof of identity;
  • Able to understand and sign the informed consent by guardians or trustees;
  • Able and willing comply with the requirements of the protocol by guardians or trustees;
  • Subjects of 2 months age have not been vaccinated with diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
  • Subjects of 3 months have not been inoculated with vaccines containing diphtheria, Hib, 13-valent pneumococcal polysaccharide conjugate vaccine and Meningococcal Group AC Bivalent Meningococcal Conjugate Vaccine;volunteers of 3 months (C3 group) have not been inoculated with vaccines containing IPV;
  • Subjects aged 18-24 months who had completed the immunization program of 3 doses of DTaP and had without the fourth DTaP vaccine ;
  • Subjects aged 4-6 years who have completed the immunization program of 4 doses of DTaP or similar vaccines containing DTP component, but who have not received DT vaccine;

Exclusion criteria

  • Premature birth in infant under 1 year of age (delivery before the 37th week of pregnancy)or low birth weight (birth weight< 2300g for girls,<2500g for boys);
  • History of abnormal labor process or asphyxia rescue ;
  • Subjects who has a medical history of diphtheria, pertussis or tetanus;
  • In the past 30 days, individuals who have had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families;
  • Allergic person;
  • Any prior administration of blood products in last 3 month;
  • Any prior administration of other research medicines in last 1 month;
  • Plans to participate in or is participating in any other drug clinical study;
  • Any prior administration of attenuated live vaccine in last 14 days;
  • Any prior administration of subunit or inactivated vaccines in last 7 days;
  • Had fever before vaccination, Subjects with temperature >37.0°C on axillary setting;
  • According to the investigator's judgment, the subjects have any other factors that make them unfit to participate in the clinical trial

Treatment and study plan

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

Biological

0.5 mL, Intramuscular Other Name: DTcP

Diphtheria and Tetanus Combined Vaccine, Adsorbed

Biological

2mL, Intramuscular Other Name: DT

Diphtheria-tetanus-acellular pertussis vaccine

Biological

0.5 mL, Intramuscular Other Name: DTaP

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

Biological

0.5 mL, Intramuscular Other Name: PENTAXIM

Primary outcomes

  1. Safety items of adverse reactions

    Time frame: within 30 minutes post-vaccination

    Occurrence of adverse reactions

  2. Safety items of adverse reactions

    Time frame: within 7 days post-vaccination

    Occurrence of adverse reactions

  3. Safety items of SAE: Occurrence of SAE

    Time frame: within 360 days post-vaccination

    Occurrence of SAE

  4. Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures

    Time frame: the fourth day post-vaccination

    Occurrence of abnormal changes of laboratory measures

  5. Safety items of adverse reactions

    Time frame: within 8-30 days post-vaccination

    Occurrence of adverse reactions

  6. Safety items of adverse reactions

    Time frame: within 30 days post-vaccination

    Occurrence of adverse reactions

Sponsors and collaborators

Lead sponsor

CanSino Biologics Inc.

Industry

Collaborators

  • Henan Center for Disease Control and Prevention

Registry information

Official study title

A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety of DTcP Vaccine in Healthy Children Aged Between 2 Months and 6 Years

Acronym: PCTDTcP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2019
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.