A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine

Study Overview
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Brief Summary
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Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old

Detailed Description
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There are five different age groups(18 55 years/7 17 years/1 6 years/7 10 months/2 months),each group has 40 people and divided into two subgroups. Each subgroup will inject different vaccine(MCV4 4μg,MCV4 8μg).For 7 10 months&2 months age groups,there are 2&3 injection seperately. Each injection interval is 1 months. After 7 days observation of 1 dose immunization in Group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. After the first dose of 7 10 months group and evaluating safety, 2 months group immunized the first dose. All participants completed the immune procedure, then observed the safety to 30 days after whole immunization. Data collection: Subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis.

Official Title
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A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine

Conditions
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Meningococcal Meningitis

Intervention / Treatment
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* Biological: freeze-dried group ACYW135 MCV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants unimmunized Group A&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2 11 months-old, and healthy toddler more than 1-year-old without booster immunization. The guardian or himself informed consent, and signed the informed consent form; The guardian and family agreed to abide by the requirements of clinical trial scheme; Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history; the axillary temperature < 37.1 ℃; 2-months-old group in the age of 61-90 days; 7-months-old group in the age of 211-300 days; 1-year-old group in age of one full year of life. Exclusion Criteria: Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history; Neomycin, streptomycin and polymyxin B allergies; With immunodeficiency, immunosuppressant therapy; History of meningitis; Women in lactation or pregnant; Acute febrile diseases and infectious diseases; History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients; Had a severe allergic reaction of vaccination in the past; Took oral steroids more than 14 days in last month; Had high fever (axillary temperature≥38.0℃ or higher)in the past three days; Prepare to attend or is in any other drug clinical study; Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 55 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: freeze-dried group ACYW135 MCV 4μg<br>4μg group: vaccines serial number is A0001-A0100（18-55 years-old group A0001-A0020，7-17 years-old group A0021-A0040，1-6 years-old group A0041-A0060，7-10 months-old group A0061-A0080，2 months-old group A0081-A0100） | Biological: freeze-dried group ACYW135 MCV<br>* Group A, C, Y and W135 Meningococcal conjugate vaccine is suitable for immune prevention of epidemic cerebrospinal meningitis more than 2 months of age population<br>|
| Experimental: freeze-dried group ACYW135 MCV 8μg<br>8μg group: vaccines serial number is B0001-B0100（18-55 years-old group B0001-B0020，7-17 years-old group B0021-B0040，1-6 years-old group B0041-B0060，7-10 months-old group B0061-B0080，2 months-old group B0081-B0100） | Biological: freeze-dried group ACYW135 MCV<br>* Group A, C, Y and W135 Meningococcal conjugate vaccine is suitable for immune prevention of epidemic cerebrospinal meningitis more than 2 months of age population<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic and local reactions 30 days after full-course vaccination |  | 30 days |