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

NCT02481232 | Unknown Phase 1 DMC

• 1 other identifier: MCV4-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meningococcal Meningitis

Outcome Measures

Primary Outcomes (1)

• systemic and local reactions 30 days after full-course vaccination

  30 days

Study Arms (2)

freeze-dried group ACYW135 MCV 4μg

EXPERIMENTAL

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

freeze-dried group ACYW135 MCV 8μg

EXPERIMENTAL

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

Interventions

freeze-dried group ACYW135 MCV 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 4μg; freeze-dried group ACYW135 MCV 8μg

Eligibility Criteria

• Age: 2 Months - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 ℃;
• months-old group in the age of 61-90 days;
• months-old group in the age of 211-300 days;
• year-old group in age of one full year of life.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lanzhou Institute of Biological Products Co., Ltd: lead
• Air Force Military Medical University, China: collaborator

Study Sites (1)

Hubei CDC

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Central Study Contacts

Zhiqiang Zhao, Manager

CONTACT

008613919133537; matinzhao@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

CN (1)