Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003

NCT01661751 | Completed Phase 3 DMC

• 2 other identifiers: Hualanbio-Meningococcal CT 003Hualanbio-phase III CT
• Study Type: interventional
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Meningitis

Keywords

Group ACYW135 Meninigococcal Polysaccharide Vaccine

Outcome Measures

Primary Outcomes (1)

• Safety

  Systemic and local adverse reactions after the vaccination; adverse events

  Dat 28 after vaccination

Secondary Outcomes (1)

• Immunogenicity

  The 4th week after immunization

Study Arms (2)

ACYW135 Meningococcal Vaccine

EXPERIMENTAL

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

A+C Meningococcal Vaccine

ACTIVE COMPARATOR

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

Interventions

ACYW135 Meningococcal Polysaccharide Vaccine BIOLOGICAL

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

Also known as: Hualan Bio

ACYW135 Meningococcal Vaccine

A+C Meningococcal Polysaccharide Vaccine BIOLOGICAL

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

Also known as: Lanzhou Institute

A+C Meningococcal 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 9, 2012
• Study Start: May 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: August 1, 2006
• Last Updated: August 9, 2012

Record last verified: 2012-08