Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 002

Phase II Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Meningitis
• Intervention / Treatment: Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine

Detailed Description

Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase II 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 Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group ACYW135 Meningococcal Polysaccharide Vaccine; 0.5 ml/ vial	Biological: Group ACYW135 Meningococcal Polysaccharide Vaccine; 360 subjects were divided into three groups (120 subjects in each group), children (2~6 years of age), early youth (7~15 years of age) and adult (16~30 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime; Other Names: Hualan Bio

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	Day 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

Collaborators and Investigators

• Sponsor: Hualan Biological Engineering, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Estimate): August 9, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Group ACYW135 Meninigococcal Polysaccharide Vaccine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Meningitis
• Other Study ID Numbers: Hualanbio-Meningococcal CT 002; Hualanbio-phase II CT (Other Grant/Funding Number: Hualan Biological Engineering Inc.)