Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children
Group A, C Polysaccharide Meningitis, Type b Haemophilus Influenza
About this trial
This is an interventional prevention trial for Group A, C Polysaccharide Meningitis focused on measuring immunogenicity, safety, group A, C polysaccharide meningitis, type b haemophilus Influenza, conjugate vaccine
Eligibility Criteria
For the children (aged from 2 to 5 years old)
Inclusion Criteria:
- Healthy subjects aged from 2 to 5 years old of normal intelligence.
- The subjects' guardians are able to understand and sign the informed consent.
- Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
- Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
- Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.
- Subjects with temperature <37°C on axillary setting.
Exclusion Criteria:
- Subject who has a medical history of Meningitis;
- Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
- Subject who is allergic with tetanus toxoid components;
- Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
- Subject who has a history of allergic reactions;
- Any known immunological dysfunction;
- Had received gamma globulin or immune globulin, in the past two weeks
- Subject suffering from congenital malformations, dysgenopathy or serious chronic disease;
- Any acute infections
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
For the infants (aged from 6 to 23 months old)
Inclusion Criteria:
- Healthy subjects aged from 6 months to 23 months old of normal intelligence.
- The subjects' guardians are able to understand and sign the informed consent.
- Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
- Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
- Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.
- Subjects with temperature<37°C on axillary setting.
Exclusion Criteria for the first vaccination:
- Subject who has a medical history of Meningitis;
- Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
- Subject who is allergic with tetanus toxoid components;
- Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
- Subject who has a history of allergic reactions;
- Any known immunological dysfunction;
- Had received gamma globulin or immune globulin, in the past two weeks
- Subject suffering from congenital malformations, dysgenopathy or serious chronic disease;
- Any acute infections
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Exclusion Criteria for the second vaccination:
- Had any Grade 3 or Grade 4 adverse reactions or events occurred since the first vaccination
- Any situation meets the exclusion criteria stated in the exclusion criteria for first dose;
- Any condition the investigator believed may affect the evaluation of the vaccine.
Sites / Locations
- Funing county Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
children group A
infants group A
children group B
infants group B
600 children aged 2-5 years old, will be vaccinated on day0
600 infants aged 6-23 months old, will be vaccinated on day0, 28
600 children aged 2-5 years old, will be vaccinated on day0
600 infants aged 6-23 months old, will be vaccinated on day0, 28