Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

Phase 1

Completed

• Conditions: Meningitis
• Interventions: Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine

• Registration Number: NCT01661725
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-04
• Primary Completion: 2006-04
• Study Completion: 2006-05
• Status Verified: 2012-08
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-06
• Last Update Submitted: 2012-08-06
• Study First Posted: 2012-08-09
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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℃.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group ACYW135 Meningococcal Polysaccharide Vaccine	Group ACYW135 Meningococcal Polysaccharide Vaccine	0.5ml/ vial

Primary Outcome Measures

Name	Time	Method
Safety	Day 28 after vaccination	All systemic and local adverse reactions and related adverse events on day 28 after the vaccination