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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diphtheria, Tetanus, Pertussis

Intervention / Treatment
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* Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
* Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed
* Biological: Diphtheria-tetanus-acellular pertussis vaccine
* Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine 1A<br>Subjects received one dose of DTaP aged 4 to 6 years. | Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed<br>* 0.5 mL, Intramuscular Other Name: DTcP<br>|
| Active Comparator: Vaccine 1B<br>Subjects received one dose of DT aged 4 to 6 years. | Biological: Diphtheria and Tetanus Combined Vaccine, Adsorbed<br>* 2mL, Intramuscular Other Name: DT<br>|
| Experimental: Vaccine 2A<br>Subjects received one dose of DTcP aged 18 to 24 months. | Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed<br>* 0.5 mL, Intramuscular Other Name: DTcP<br>|
| Active Comparator: Vaccine 2B<br>Subjects received one dose of DTaP aged 18 to 24 months. | Biological: Diphtheria-tetanus-acellular pertussis vaccine<br>* 0.5 mL, Intramuscular Other Name: DTaP<br>|
| Experimental: Vaccine 3A<br>Subjects received three doses of DTcP at 3,4,5 months of age. | Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed<br>* 0.5 mL, Intramuscular Other Name: DTcP<br>|
| Active Comparator: Vaccine 3B<br>Subjects received three doses of DTaP at 3,4,5 months of age. | Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed<br>* 0.5 mL, Intramuscular Other Name: DTcP<br>Biological: Diphtheria-tetanus-acellular pertussis vaccine<br>* 0.5 mL, Intramuscular Other Name: DTaP<br>|
| Active Comparator: Vaccine 3C<br>Subjects received three doses of DTaP-IPV-Hib at 3,4,5 months of age. | Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine<br>* 0.5 mL, Intramuscular Other Name: PENTAXIM<br>|
| Experimental: Vaccine 4A<br>Subjects received three doses of DTcP at 2,3,4 months of age. | Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed<br>* 0.5 mL, Intramuscular Other Name: DTcP<br>|
| Active Comparator: Vaccine 4B<br>Subjects received three doses of DTaP-IPV-Hib at 2,3,4 months of age. | Biological: Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine<br>* 0.5 mL, Intramuscular Other Name: PENTAXIM<br>|
| Experimental: Vaccine 4C<br>Subjects received three doses of DTcP at 2,4,6 months of age. | Biological: Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed<br>* 0.5 mL, Intramuscular Other Name: DTcP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection, DTcP, Whooping Cough, Vaccine, Diphtheria, Tetanus, Pertussis