A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
- Conditions
- Meningococcal Meningitis
- Interventions
- Biological: freeze-dried group ACYW135 MCV
- Registration Number
- NCT02481232
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description freeze-dried group ACYW135 MCV 8μg freeze-dried group ACYW135 MCV 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） freeze-dried group ACYW135 MCV 4μg freeze-dried group ACYW135 MCV 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）
- Primary Outcome Measures
Name Time Method systemic and local reactions 30 days after full-course vaccination 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hubei CDC
🇨🇳Wuhan, Hubei, China