Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003

Phase 3

Completed

• Conditions: Meningitis
• Interventions: Biological: ACYW135 Meningococcal Polysaccharide Vaccine; Biological: A+C Meningococcal Polysaccharide Vaccine

• Registration Number: NCT01661751
• Lead Sponsor: Hualan Biological Engineering, Inc.

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-05
• Study Completion: 2006-08
• Status Verified: 2012-08
• Study First Submitted: 2012-08-03
• 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: 900

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACYW135 Meningococcal Vaccine	ACYW135 Meningococcal Polysaccharide Vaccine	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
A+C Meningococcal Vaccine	A+C Meningococcal Polysaccharide Vaccine	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

Primary Outcome Measures

Name	Time	Method
Safety	Dat 28 after vaccination	Systemic and local adverse reactions after the vaccination; adverse events

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	The 4th week after immunization	4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization