Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A
 and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.

 Primary objective:

 -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups
 A, C and Haemophilus influenzae type b following the administration of adjuvant-free
 MenAC-Hib conjugate vaccine compared to those observed following the administration of
 adjuvant MenAC-Hib conjugate vaccine.

 -  To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to
 that of adjuvant MenAC-Hib conjugate vaccine.

 Secondary objective:

 •To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae
 type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those
 observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
Inclusion Criteria:

 -  Health infants aged 2 to 5 months.

 -  Legal guardian has signed written informed consent.

 -  Guardian may finish the whole visit in the judgment of investigator.

 -  2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate
 Vaccine or Haemophilus b Conjugate Vaccine.

 -  Subject who did't vaccinated with any live vaccine within 14 days or inactivated
 vaccine within 10 days before vaccination.

 Exclusion Criteria:

 -  Fever, body temperature ≥37.1℃.

 -  History of severe allergic reaction that needs medical intervention including throat
 swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to
 any of the vaccine components especially to tetanus toxoid or history of other severe
 adverse reaction to vaccine.

 -  Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may
 cause contraindications of intramuscular injection.

 -  Subject with history of abnormal labor, asphyxia rescue history,congenital
 malformations,eccyliosis or severe chronic disease.

 -  Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV
 infection.

 -  Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous
 system disease.

 -  Subject suffer from acute disease, severe chronic disease, acute episode of chronic
 disease and febrile illness (temperature ≥ 38°C) within 3 days.

 -  Any condition that, in the judgment of investigator, subject is not suitable for
 participation in this clinical trial.