Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003
This study has been completed.
Sponsor:
Hualan Biological Engineering, Inc.
Information provided by (Responsible Party):
Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier:
NCT01661751
First received: August 3, 2012
Last updated: August 6, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis |
Biological: ACYW135 Meningococcal Polysaccharide Vaccine Biological: A+C Meningococcal Polysaccharide Vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Phase III Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine |
Resource links provided by NLM:
Further study details as provided by Hualan Biological Engineering, Inc.:
Primary Outcome Measures:
- Safety [ Time Frame: Dat 28 after vaccination ] [ Designated as safety issue: Yes ]Systemic and local adverse reactions after the vaccination; adverse events
Secondary Outcome Measures:
- Immunogenicity [ Time Frame: The 4th week after immunization ] [ Designated as safety issue: Yes ]4-fold (seroconversion) and 8-fold increase of bactericidin; GMT and bactericidin increase after immunization
| Enrollment: | 900 |
| Study Start Date: | May 2006 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ACYW135 Meningococcal 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
|
Biological: ACYW135 Meningococcal Polysaccharide Vaccine
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
Other Name: Hualan Bio
|
|
Active Comparator: A+C Meningococcal 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
|
Biological: A+C Meningococcal Polysaccharide Vaccine
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
Other Name: Lanzhou Institute
|
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.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hualan Biological Engineering, Inc. |
| ClinicalTrials.gov Identifier: | NCT01661751 History of Changes |
| Other Study ID Numbers: | Hualanbio-Meningococcal CT 003, Hualanbio-phase III CT |
| Study First Received: | August 3, 2012 |
| Last Updated: | August 6, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Hualan Biological Engineering, Inc.:
|
Group ACYW135 Meninigococcal Polysaccharide Vaccine |
Additional relevant MeSH terms:
|
Meningitis Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013