Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003

Study Overview
=================
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.

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.

Official Title
-----------------
Phase III Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

Conditions
-----------------
Meningitis

Intervention / Treatment
-----------------
* Biological: ACYW135 Meningococcal Polysaccharide Vaccine
* Biological: A+C Meningococcal Polysaccharide Vaccine


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACYW135 Meningococcal Vaccine<br>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<br>* 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<br>* Other names: Hualan Bio;|
| Active Comparator: A+C Meningococcal Vaccine<br>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<br>* 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<br>* Other names: Lanzhou Institute;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Systemic and local adverse reactions after the vaccination; adverse events | Dat 28 after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | 4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization | The 4th week after immunization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group ACYW135 Meninigococcal Polysaccharide Vaccine