Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .
Phase 1
Completed
- Conditions
- DiphtheriaTetanusPertussis
- Interventions
- Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, AdsorbedBiological: Diphtheria-tetanus-acellular pertussis vaccineBiological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccineBiological: Diphtheria and Tetanus Combined Vaccine, Adsorbed
- Registration Number
- NCT04099303
- Lead Sponsor
- CanSino Biologics Inc.
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaccine 1A Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed Subjects received one dose of DTaP aged 4 to 6 years. Vaccine 2B Diphtheria-tetanus-acellular pertussis vaccine Subjects received one dose of DTaP aged 18 to 24 months. Vaccine 3B Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed Subjects received three doses of DTaP at 3,4,5 months of age. Vaccine 4A Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed Subjects received three doses of DTcP at 2,3,4 months of age. Vaccine 2A Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed Subjects received one dose of DTcP aged 18 to 24 months. Vaccine 3A Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed Subjects received three doses of DTcP at 3,4,5 months of age. Vaccine 4B Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age. Vaccine 1B Diphtheria and Tetanus Combined Vaccine, Adsorbed Subjects received one dose of DT aged 4 to 6 years. Vaccine 3C Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age. Vaccine 4C Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed Subjects received three doses of DTcP at 2,4,6 months of age. Vaccine 3B Diphtheria-tetanus-acellular pertussis vaccine Subjects received three doses of DTaP at 3,4,5 months of age.
- Primary Outcome Measures
Name Time Method Safety items of adverse reactions within 30 days post-vaccination Occurrence of adverse reactions
Safety items of SAE: Occurrence of SAE within 360 days post-vaccination Occurrence of SAE
Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures the fourth day post-vaccination Occurrence of abnormal changes of laboratory measures
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Changge Center for Disease Control and Prevention
🇨🇳Xuchang, Henan, China