Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

NCT01661725 | Completed Phase 1 DMC

• 2 other identifiers: Hualanbio-Meningococcal CT 001Hualanbio-phase I CT
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Meningitis

Keywords

Group ACYW135 Meningococcal Polysaccharide Vaccine

Outcome Measures

Primary Outcomes (1)

• Safety

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

  Day 28 after vaccination

Study Arms (1)

Group ACYW135 Meningococcal Polysaccharide Vaccine

EXPERIMENTAL

0.5ml/ vial

Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine

Interventions

Group ACYW135 Meningococcal Polysaccharide Vaccine BIOLOGICAL

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

Also known as: Hualan Bio

Group ACYW135 Meningococcal Polysaccharide Vaccine

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hualan Biological Engineering, Inc.: lead

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Fubao Ma, Bachelor

  Immunization Program Institute of Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 9, 2012
• Study Start: April 1, 2006
• Primary Completion: April 1, 2006
• Study Completion: May 1, 2006
• Last Updated: August 9, 2012

Record last verified: 2012-08