Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children

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 Read More

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.