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

Lanzhou Institute of Biological Products

Status and phase: Unknown; Phase 1

Conditions: Meningococcal Meningitis

Treatments: Biological: freeze-dried group ACYW135 MCV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02481232

MCV4-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2 months to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

freeze-dried group ACYW135 MCV 4μg

Experimental group

Description:

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）

Treatment:

Biological: freeze-dried group ACYW135 MCV

freeze-dried group ACYW135 MCV 8μg

Experimental group

Description:

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）

Treatment:

Biological: freeze-dried group ACYW135 MCV