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

June 23, 2015 updated by: Lanzhou Institute of Biological Products Co., Ltd
Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei CDC
        • Contact:
          • Faxian Zhan, Manager
          • Phone Number: 008613908639947
          • Email: zhanfx@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
systemic and local reactions 30 days after full-course vaccination
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lanzhou Institute of Biological Products Co., Ltd

Collaborators

Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCV4-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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