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Category:Bio Products > Sera and Vaccines > Vaccine
Product Name:Hualan Bio Meningococcal Polysaccharide Vaccine Group ACYW135
Price(USD):0.00
Company:Hualan Biological Vaccine Inc.
Factory Location: Xinxiang, Henan, China
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Contract Manufacturing: CRO,CMO
Packaging Information: penicillin bottle
Delivery Lead Time: 1 MONTH
Sample Provided: yes
Payment Terms: LC/TT
Meningococcal Polysaccharide Vaccine Group ACYW135
Active ingredients: Group A, C, Y, W135 Neisseria meningitides capsule polysaccharide.
| 200μg/vial |
Meningococcal Polysaccharide Vaccine Group ACYW135
Comparison of quality indexes of Group A, C, W135 and Y Meningococcal Polysaccharide Vaccine according to different specifications
| Test item | Specification of the Chinese Pharmacopoeia (CP) (2010 version) | In-house specification of Hualan | Testing results in 2010 | |
| Protein content (mg/g) |
A | ≤8 | ≤5 | 2.6 |
| C | ≤8 | ≤5 | 1.8 | |
| Y | -- | ≤5 | 0.8 | |
| W135 | -- | ≤5 | 0.3 | |
| Endotoxin content (EU/μg polysaccharide) |
A | ≤25 | ≤5 | 0.4 |
| C | ≤25 | ≤5 | 0.7 | |
| Y | -- | ≤5 | 0.1 | |
| W135 | -- | ≤5 | 3.4 | |
Safety of the vaccine
The phase III clinical trial of Group A, C, W135 and Y Meningococcal Polysaccharide Vaccine was conducted by Jiangsu CDC from May to Aug. 2006. 900 subjects were included according to the clinical trial protocol. The trial adopted randomized, blinding and control design and subjects were divided into three groups administered Group A, C, W135 and Y Meningococcal Polysaccharide Vaccine of Hualan and control vaccine respectively.
Results of the clinical trial
| Group | Vaccine | Incidence of systemic reactions (%) | Incidence of local reactions (%) | Total incidence (%) |
| Children | Test vaccine | 7.0 | 1.5 | 8.5 |
| Control vaccine | 6.0 | 3.0 | 9.0 | |
| Teenager | Test vaccine | 2.0 | 0.5 | 2.5 |
| Control vaccine | 3.0 | 0.0 | 3.0 | |
| Adult | Test vaccine | 1.5 | 0.5 | 2.0 |
| Control vaccine | 0.0 | 2.0 | 2.0 |
Conclusion on the safety:The phase III clinical trial of Group A, C, W135 and Y Meningococcal Polysaccharide Vaccine of Hualan showed that incidences of systemic reaction and local reaction of the two vaccine groups were low.
Efficacy of the vaccine
Summary of GMT increases of group A, C, W135 and Y
| Group | Subjects | Antibody increase (G±Sd) | |||
| Group A | Group C | Group W135 | Group Y | ||
| Test Vaccine | 480 | 228.73± 3.76 |
74.16± 7.99 |
156.91± 4.12 |
181.02± 4.67 |
| Control vaccine | 240 | 319.76± 3.54 |
91.03± 7.32 |
1.52± 2.30 |
1.75± 2.22 |
Note: G is geometric mean; sd is the corresponding standard deviation
Conclusion on the efficacy: Antibody seroconversion ratios, GMT and antibody increases of each group after immunization showed that the Group A, C, W135 and Y Meningococcal Polysaccharide Vaccine of Hualan had a good immunogenicity performance in subjects 2 years of age and older.
Trial results showed that: the Group A, C, W135 and Y Meningococcal Polysaccharide Vaccine of Hualan had a good safety and efficacy performance and complied with related specifications of the CP and EU Pharmacopoeia.
Meningococcal Polysaccharide Vaccine Group ACYW135
Tel：+86-373-3559991
E-mail：hualan@hualanbio.com
Add：Jia No.1, Hualan Ave., Xinxiang, Henan Province, P.R.China
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