Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine

This is an interventional prevention trial for Meningitis focused on measuring immunogenicity, safety, group A, C polysaccharide meningitis, type b haemophilus Influenza Read More

Inclusion Criteria:

• Healthy subjects aged 3 to 5 months, normal intelligence.
• The subjects' guardians are able to understand and sign the informed consent.
• Healthy subjects confirmed by 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 who 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
• Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
• Any acute infections in last 7 days
• Any prior administration of immunodepressant or corticosteroids in last 6month
• Any prior administration of other research medicines in last 1 month
• Any prior administration of attenuated live vaccine in last 28 days
• Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
• Subject suffering from congenital malformations, developmental delay 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 or third vaccination:

• Had any Grade 3 or Grade 4 adverse reactions or events associated with investigational vaccine occurred since the vaccination
• Any situation meets the exclusion criteria for first dose;
• Any condition the investigator believed may affect the evaluation of the vaccine.