Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .
PCTDTcP
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
1 other identifier
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedStudy Start
First participant enrolled
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2021
CompletedOctober 31, 2022
October 1, 2022
1.5 years
September 18, 2019
October 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Safety items of adverse reactions
Occurrence of adverse reactions
within 30 minutes post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
within 7 days post-vaccination
Safety items of SAE: Occurrence of SAE
Occurrence of SAE
within 360 days post-vaccination
Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures
Occurrence of abnormal changes of laboratory measures
the fourth day post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
within 8-30 days post-vaccination
Safety items of adverse reactions
Occurrence of adverse reactions
within 30 days post-vaccination
Study Arms (10)
Vaccine 1A
EXPERIMENTALSubjects received one dose of DTaP aged 4 to 6 years.
Vaccine 1B
ACTIVE COMPARATORSubjects received one dose of DT aged 4 to 6 years.
Vaccine 2A
EXPERIMENTALSubjects received one dose of DTcP aged 18 to 24 months.
Vaccine 2B
ACTIVE COMPARATORSubjects received one dose of DTaP aged 18 to 24 months.
Vaccine 3A
EXPERIMENTALSubjects received three doses of DTcP at 3,4,5 months of age.
Vaccine 3B
ACTIVE COMPARATORSubjects received three doses of DTaP at 3,4,5 months of age.
Vaccine 3C
ACTIVE COMPARATORSubjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age.
Vaccine 4A
EXPERIMENTALSubjects received three doses of DTcP at 2,3,4 months of age.
Vaccine 4B
ACTIVE COMPARATORSubjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age.
Vaccine 4C
EXPERIMENTALSubjects received three doses of DTcP at 2,4,6 months of age.
Interventions
0.5 mL, Intramuscular Other Name: DTcP
2mL, Intramuscular Other Name: DT
0.5 mL, Intramuscular Other Name: DTaP
0.5 mL, Intramuscular Other Name: PENTAXIM
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changge Center for Disease Control and Prevention
Xuchang, Henan, 461500, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang Yanxia
Henan Province Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2019
First Posted
September 23, 2019
Study Start
April 28, 2020
Primary Completion
October 27, 2021
Study Completion
November 25, 2021
Last Updated
October 31, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
In order to maintain the rights of the subject, do not open the IPD