Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine

Study Overview
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Brief Summary
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The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.

Official Title
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Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China

Conditions
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Meningitis

Intervention / Treatment
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* Biological: MCV-ACYW135 Vaccine Group
* Biological: MPV-ACYW135 Vaccine Group
* Biological: MPV-A Vaccine Group
* Biological: MCV-AC Vaccine Group
* Biological: Hib Vaccine Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. Healthy permanent residence 2 months to 6 years old. Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures. Axillary temperature ≤37.0 ℃. Exclusion Criteria: History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months. Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia. Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial. Receipt of blood or blood-derived products in the 3 months preceding vaccination Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination. Receipt of any live virus vaccine in the 15 days preceding vaccination. Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination. Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination. Thrombocytopenia. History of thyroid gland excision or treatment for thyroid gland disease in last 12 months. Functional or anatomic asplenia. History of eclampsia, epilepsy, encephalopathy and mental disease or family disease. Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome). Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc. Any condition that, in the judgment of investigator, may affect trial assessment.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCV-ACYW135 Vaccine Group<br>Participants at age 2 to 6 years of enrollment will receive 1 dose on Meningococcal ( A, C, Y and W 135) conjugate vaccine. Participants at age 6 to 23 months of enrollment will receive 2 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 3 months apart. Participants at age 3 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 1 month apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Meningococcal ( A, C, Y and W 135) conjugate vaccine at 2 months apart. | Biological: MCV-ACYW135 Vaccine Group<br>* 0.5ml, intramuscular<br>* Other names: Meningococcal ( A, C, Y and W 135) conjugate vaccine;|
| Active Comparator: MPV-ACYW135 Vaccine Group<br>Participants at age 2 to 6 years of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine | Biological: MPV-ACYW135 Vaccine Group<br>* 0.5ml, intramuscular<br>* Other names: Group A, C, Y and W-135 Meningococcal Polysaccharide Vaccine;|
| Active Comparator: MPV-A Vaccine Group<br>Participants at age 6 to 23 months of enrollment will receive 2 doses on Group A Meningococcal Polysaccharide vaccine at 3 months apart. | Biological: MPV-A Vaccine Group<br>* 0.5ml, intramuscular<br>* Other names: Group A Meningococcal Polysaccharide vaccine;|
| Active Comparator: MCV-AC Vaccine Group<br>Participants at age 3 to 5 months of enrollment will receive 3 doses on Group A and C Meningococcal conjugate vaccine at 1 month apart. | Biological: MCV-AC Vaccine Group<br>* 0.5ml, intramuscular<br>* Other names: Group A and C Meningococcal conjugate vaccine;|
| Placebo Comparator: Hib Vaccine Group<br>Participants at age 2 to 5 months of enrollment will receive 3 doses on Haemophilus Influenzae Type b Conjugate Vaccine at 2 months apart. | Biological: Hib Vaccine Group<br>* 0.5ml, intramuscular<br>* Other names: Haemophilus Influenzae Type b Conjugate Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination |  | 28 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the adverse reactions after vaccination |  | Within 28 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunogenicity, Safety, Meningococcal Conjugate Vaccine