Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier:
NCT01661725
First received: August 2, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Meningitis
Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

Resource links provided by NLM:


Further study details as provided by Hualan Biological Engineering, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Day 28 after vaccination ] [ Designated as safety issue: Yes ]
    All systemic and local adverse reactions and related adverse events on day 28 after the vaccination


Enrollment: 60
Study Start Date: April 2006
Study Completion Date: May 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group ACYW135 Meningococcal Polysaccharide Vaccine
0.5ml/ vial
Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine
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
Other Name: Hualan Bio

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661725

Sponsors and Collaborators
Hualan Biological Engineering, Inc.
Investigators
Principal Investigator: Fubao Ma, Bachelor Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier: NCT01661725     History of Changes
Other Study ID Numbers: Hualanbio-Meningococcal CT 001, Hualanbio-phase I CT
Study First Received: August 2, 2012
Last Updated: August 6, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Hualan Biological Engineering, Inc.:
Group ACYW135 Meningococcal Polysaccharide Vaccine

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014