Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

Conditions
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Meningitis

Intervention / Treatment
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* Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group ACYW135 Meningococcal Polysaccharide Vaccine<br>0.5ml/ vial | Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine<br>* 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<br>* Other names: Hualan Bio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | All systemic and local adverse reactions and related adverse events on day 28 after the vaccination | Day 28 after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group ACYW135 Meningococcal Polysaccharide Vaccine