Diphtheria, Tetanus, Whooping Cough
Conditions
Brief summary
The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts: PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM)，compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence. PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.
Interventions
Intramuscular injection
BIOLOGICALDiphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed
Intramuscular injection
Sponsors
Beijing Institute of Biological Products Co Ltd.
China National Biotec Group Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 3 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ； * Willing to provide proof of identity * Subjects aged 2 months have not been vaccinated with DTaP, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine; * Subjects of 3 months have not been inoculated with DTaP vaccine, and IPV (only group A3）； * Subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan.
Exclusion criteria
* With temperature \>37.0°C on axillary setting before vacciation; * With a medical history of diphtheria, pertussis or tetanus; * Had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days; * Premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight\< \<2500g); * History of dystocia, suffocation rescue, neurological damage; * With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * History of epilepsy, convulsions or convulsions, or have a family history of mental illness; * History of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy); * Had received immune enhancement or inhibitor therapy (continuous oral or instillation for more than 14 days); * History of severe allergic reactions to vaccination, such as difficulty breathing, urticaria; * Any prior administration of blood products in last 3 month; * Any prior administration of attenuated live vaccine in last 14 days; * Any prior administration of subunit or inactivated vaccines in last 7 days; * Plans to participate in or is participating in any other drug clinical study; * Has any other factors judged by investigators that make them unfit to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting adverse events | within 30 days post-each dose | As elicited by investigational site staff |
| The seroconversion rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | 1 month after Dose 3 | seroconversion is defined as post-third dose antibody concentrations ≥ protective antibody concentration if pre-vaccination concentration is \< protective antibody concentration, or ≥ 4 x protective antibody concentration if pre-vaccination concentrations ≥ protective antibody concentration. |
| Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | 1 month after Dose 3 | As measured at the central laboratory |
| Percentage of participants reporting local reactions | Day 7 post-each dose | As elicited by investigational site staff |
| Percentage of participants reporting systemic events | Day 7 post-each dose | As elicited by investigational site staff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | Day 30 post-dose 3 | Seropositivity is defined as post-3 dose antibody concentrations ≥ protective antibody concentration |
| Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | before dose 4 at 18 months old(booster) | As measured at the central laboratory |
Other
| Measure | Time frame | Description |
|---|---|---|
| The seropositivity rate of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5 | Seropositivity is defined as antibody concentrations ≥ protective antibody concentration |
| Geometric Mean Concentrations (GMCs) of anti-pertussis toxoid , anti-filamentous hemagglutinin, anti-Pertactin, anti-diphtheria toxoid and anti-tetanic antibody | 12th month, 24th month, 36th month post-dose 4 , before 6 years old and day 30 post-dose 5 | As measured at the central laboratory |
Countries
China
Outcome results
None listed