Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier:
NCT01661751
First received: August 3, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.


Condition Intervention Phase
Meningitis
Biological: ACYW135 Meningococcal Polysaccharide Vaccine
Biological: A+C Meningococcal Polysaccharide Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase III 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: Dat 28 after vaccination ] [ Designated as safety issue: Yes ]
    Systemic and local adverse reactions after the vaccination; adverse events


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: The 4th week after immunization ] [ Designated as safety issue: Yes ]
    4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization


Enrollment: 900
Study Start Date: May 2006
Study Completion Date: August 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACYW135 Meningococcal Vaccine
0.5 ml/ dose, containing 50 μg of each antigen; lot No.: 20040601, manufacturing date: June 9, 2004 and the expiration date: till June 2006
Biological: ACYW135 Meningococcal Polysaccharide Vaccine
600 subjects were divided into three groups (200 subjects in 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
Active Comparator: A+C Meningococcal Vaccine
0.5 ml/ dose; each ampoule or dose contains 100 μg (one single human dose) and 50 μg of each antigen; lot No.: 20050805 and the expiration date: Aug. 24, 2007
Biological: A+C Meningococcal Polysaccharide Vaccine
300 subjects were divided into three groups (100 subjects in 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 AC Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
Other Name: Lanzhou Institute

Detailed Description:

Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase III clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine.

The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661751

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: NCT01661751     History of Changes
Other Study ID Numbers: Hualanbio-Meningococcal CT 003, Hualanbio-phase III CT
Study First Received: August 3, 2012
Last Updated: August 6, 2012
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014