Back to resultsA Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
Primary Purpose
Meningococcal Meningitis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
freeze-dried group ACYW135 MCV
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Meningitis
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.
Sites / Locations
- Hubei CDCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
freeze-dried group ACYW135 MCV 4μg
freeze-dried group ACYW135 MCV 8μg
Arm 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）
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）
Outcomes
Primary Outcome Measures
systemic and local reactions 30 days after full-course vaccination
Secondary Outcome Measures
Full Information
NCT ID
NCT02481232
First Posted
June 23, 2015
Last Updated
June 23, 2015
Sponsor
Lanzhou Institute of Biological Products Co., Ltd
Collaborators
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02481232
Brief Title
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
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lanzhou Institute of Biological Products Co., Ltd
Collaborators
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
freeze-dried group ACYW135 MCV 4μg
Arm Type
Experimental
Arm 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）
Arm Title
freeze-dried group ACYW135 MCV 8μg
Arm Type
Experimental
Arm 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）
Intervention Type
Biological
Intervention Name(s)
freeze-dried group ACYW135 MCV
Intervention Description
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
Primary Outcome Measure Information:
Title
systemic and local reactions 30 days after full-course vaccination
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiqiang Zhao, Manager
Phone
008613919133537
Email
matinzhao@sina.com
Facility Information:
Facility Name
Hubei CDC
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faxian Zhan, Manager
Phone
008613908639947
Email
zhanfx@163.com
12. IPD Sharing Statement
Learn more about this trial
A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
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