Meningococcal Meningitis
Conditions
Brief summary
Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old
Detailed description
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.
Interventions
BIOLOGICALfreeze-dried group ACYW135 MCV
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
Sponsors
Air Force Military Medical University, China
Lanzhou Institute of Biological Products Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| systemic and local reactions 30 days after full-course vaccination | 30 days |
Countries
China
Contacts
Primary ContactZhiqiang Zhao, Manager
Outcome results
None listed