Trial record 42 of 3823 for:    vaccine clinical trials

Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661725
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : August 9, 2012
Information provided by (Responsible Party):
Hualan Biological Engineering, Inc.

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.

Condition or disease Intervention/treatment Phase
Meningitis Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine
Study Start Date : April 2006
Actual Primary Completion Date : April 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety [ Time Frame: Day 28 after vaccination ]
    All systemic and local adverse reactions and related adverse events on day 28 after the vaccination

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01661725

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

Responsible Party: Hualan Biological Engineering, Inc. Identifier: NCT01661725     History of Changes
Other Study ID Numbers: Hualanbio-Meningococcal CT 001
Hualanbio-phase I CT ( Other Grant/Funding Number: Hualan Biological Engineering Inc. )
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Central Nervous System Diseases
Nervous System Diseases
Immunologic Factors
Physiological Effects of Drugs