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

NCT ID: NCT02481232

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Meningococcal Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

freeze-dried group ACYW135 MCV 4μg

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）

Group Type: EXPERIMENTAL

freeze-dried group ACYW135 MCV

Intervention Type: BIOLOGICAL

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

freeze-dried group ACYW135 MCV 8μg

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）

Group Type: EXPERIMENTAL

freeze-dried group ACYW135 MCV

Intervention Type: BIOLOGICAL

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

Interventions

freeze-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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

Lanzhou Institute of Biological Products Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hubei CDC

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiqiang Zhao, Manager

Role: CONTACT

matinzhao@sina.com

008613919133537

Facility Contacts

Faxian Zhan, Manager

Role: primary

zhanfx@163.com

008613908639947

Other Identifiers

MCV4-001

Identifier Type: -

Identifier Source: org_study_id