Clinical trial NCT02481232: A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
Official title: A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Meningococcal Meningitis
Lead sponsor: Lanzhou Institute of Biological Products Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Air Force Military Medical University, China
First posted: 2015-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: systemic and local reactions 30 days after full-course vaccination
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei CDC
state: Hubei
Study officials:
References: