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

Sponsored by Lanzhou Institute of Biological Products Co., Ltd

About this trial

Last updated 10 years ago

Study ID

MCV4-001

Status

Unknown status

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
2 to 55 Years
All
All

Trial Timing

Ended 9 years ago

What is this trial about?

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

What are the participation requirements?

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.

No

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.