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Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

Primary Purpose

Meningitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Group ACYW135 Meningococcal Polysaccharide Vaccine
Sponsored by
Hualan Biological Engineering, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis focused on measuring Group ACYW135 Meningococcal Polysaccharide Vaccine

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
  • Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
  • Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
  • Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
  • Axillary temperature ≤37.0℃.

Exclusion Criteria:

  • Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
  • Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
  • History of neurologic symptom or signs;
  • Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
  • History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
  • History of receiving other vaccines or immunoglobulin injection or any research drugs;
  • Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week;
  • History of fever within the past 3 days (axillary temperature ≥38.0℃);
  • Participating in another clinical trial;
  • History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
  • Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection;
  • Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome);
  • Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.;
  • Pregnancy;
  • Any condition that, in the judgment of investigator, may affect trial assessment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Group ACYW135 Meningococcal Polysaccharide Vaccine

    Arm Description

    0.5ml/ vial

    Outcomes

    Primary Outcome Measures

    Safety
    All systemic and local adverse reactions and related adverse events on day 28 after the vaccination

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2012
    Last Updated
    August 6, 2012
    Sponsor
    Hualan Biological Engineering, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01661725
    Brief Title
    Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001
    Official Title
    Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    April 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hualan Biological Engineering, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.
    Detailed Description
    Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meningitis
    Keywords
    Group ACYW135 Meningococcal Polysaccharide Vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group ACYW135 Meningococcal Polysaccharide Vaccine
    Arm Type
    Experimental
    Arm Description
    0.5ml/ vial
    Intervention Type
    Biological
    Intervention Name(s)
    Group ACYW135 Meningococcal Polysaccharide Vaccine
    Other Intervention Name(s)
    Hualan Bio
    Intervention Description
    60 subjects were divided into three groups (20 subjects each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
    Primary Outcome Measure Information:
    Title
    Safety
    Description
    All systemic and local adverse reactions and related adverse events on day 28 after the vaccination
    Time Frame
    Day 28 after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent; Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product; Be able to comply with the requirements of clinical trial protocol and immunogenicity examination; Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks; Axillary temperature ≤37.0℃. Exclusion Criteria: Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.; Allergic to vaccines or drugs (history of allergy to any vaccine in the past); History of neurologic symptom or signs; Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.; History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months; History of receiving other vaccines or immunoglobulin injection or any research drugs; Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week; History of fever within the past 3 days (axillary temperature ≥38.0℃); Participating in another clinical trial; History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease; Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection; Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome); Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.; Pregnancy; Any condition that, in the judgment of investigator, may affect trial assessment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fubao Ma, Bachelor
    Organizational Affiliation
    Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

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