Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02481232
Recruitment Status : Unknown
Verified June 2015 by Lanzhou Institute of Biological Products Co., Ltd.
Recruitment status was:  Recruiting
First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by (Responsible Party):
Lanzhou Institute of Biological Products Co., Ltd

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

Condition or disease Intervention/treatment Phase
Meningococcal Meningitis Biological: freeze-dried group ACYW135 MCV Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
Study Start Date : June 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Arm Intervention/treatment
Experimental: 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)
Biological: 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

Experimental: 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)
Biological: 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




Primary Outcome Measures :
  1. systemic and local reactions 30 days after full-course vaccination [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481232


Contacts
Layout table for location contacts
Contact: Zhiqiang Zhao, Manager 008613919133537 matinzhao@sina.com

Locations
Layout table for location information
China, Hubei
Hubei CDC Recruiting
Wuhan, Hubei, China, 430079
Contact: Faxian Zhan, Manager    008613908639947    zhanfx@163.com   
Sponsors and Collaborators
Lanzhou Institute of Biological Products Co., Ltd
Fourth Military Medical University

Layout table for additonal information
Responsible Party: Lanzhou Institute of Biological Products Co., Ltd
ClinicalTrials.gov Identifier: NCT02481232     History of Changes
Other Study ID Numbers: MCV4-001
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningitis, Bacterial
Vaccines
Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs