Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningitis, Meningococcal Meningitis, Meningococcal Infections

Intervention / Treatment
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* Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)
* Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant-Free MenAC-Hib Conjugate Vaccine Group<br>Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine. | Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)<br>* 30μg /dose, Intramuscular<br>* Other names: MenAC-Hib;|
| Active Comparator: Adjuvant MenAC-Hib Conjugate Vaccine Group<br>Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine. | Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)<br>* 0.5ml /dose, Intramuscular<br>* Other names: MenAC-Hib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine |  | Day 30 post-vaccination | 
| Occurrence of adverse events during a 30 day follow-up period after each vaccination |  | 30 day after each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of severe adverse events within six months post-vaccination |  | six months post-vaccination | 
| Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine |  | Day 30 post-vaccination |