1. Produced by excellent bacteria strains.
2. According to WHO recommended standard for production.
3. Advanced purification process system improve the product quality greatly, and lower the side effect.
4. The independent and complete cold chain transportation system.
5. Complete vaccination risk management system
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|
Endotoxin content (EU/μg polysaccharide)
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 (%)||
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|
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.
Strains (CMCC 29201 A4, CMCC 29205 C11, CMCC 29055 W135 and CMCC 29303 Y) of group A, C, Y and W135 Neisseria meningitides come from the China Medical Culture Collection (CMCC) of the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). The Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine of Hualan is prepared by purifying polysaccharide antigens of the four Neisseria meningitides. One single dose can protect people against any of the four bacteria; therefore, it has a much more extensive protection range.
Adopt advanced fermentation and purification equipment and the whole production line can automatically control process parameters. Online monitor the growth of colonies using temperature and oxygen content probes in the tank under the condition of fully closed; the automatic program control greatly improves the product quality and decreases the incidence of adverse reactions by adding nutrition facts for the growth and adjusting the growth environment. Hualan adopts the chromatography method to eliminate the pyrogen in product so that the content of pyrogen substances in the vaccine much lower. Therefore, the incidence of fever after administering vaccine is greatly decreased and the safety of vaccine is effectively improved.
High-speed filing and packaging capacity: Several automatic filling lines were equipped in the filling and packaging center. HualanBio possesses the high-speed filing and packaging line with fastest speed and best quality in China. Hualan promises users there is no sub batch and the quality of vaccine is much more homogenous and reliable.
The bulk production workshop of Hualan meningococcal vaccine can manufacture 50 million doses of vaccines a year. The filling line II in the filling workshop has the ability to fill 12 million doses, which can be quickly increased to 50 million doses if serious epidemics happen.
Internationalization quality management and risk control management: Implement according to standards of the WHO in all aspects. Satisfy needs of customers abroad with international quality. Guarantee the production system via facility validation, equipment validation, process validation and so on. Establish a rapid and accurate information feedback and tracking system to ensure the safety and traceability of each vial of product from the use of raw material to the distribution. Analyze and control the quality risk during vaccine manufacturing by means of annual quality review and quality trend analysis. Actively promote the progress of the WHO prequalification and EU qualification.
Hualan appointed liaison men in 31 provinces of China. The well-established risk management system can respond to AEFI events occurred during vaccine use as soon as possible and ensure they can be handled immediately.
Package insert of Group ACYW135 Meningococcal Polysaccharide Vaccine
Generic Name: Group ACYW135 Meningococcal Polysaccharide Vaccine
English Name: Group ACYW135 Meningococcal Polysaccharide Vaccine
Chinese Pinyin: ACYW135 Qun Naomoyanqiujun Duotang Yimiao
[Constituents and [A1] ]Meningococcal Polysaccharide Vaccine Group ACYW135 is lyophilized[u2] preparation made from Group A, C, Y, W135 Neisseria meningitides culture by extracting and purifying the respective polysaccharide antigen, mixing and then adding in suitable stabilizer. The final product looks like a white crisp cake, and after reconstitution by adding the attached solvent, into a clear liquid.
Active ingredients: Group A, C, Y, W135 Neisseria meningitides capsule polysaccharide.
Solvent: sterile, non-pyrogenic PBS.
At present, the vaccine is only recommended to be used in high-risk population (children and adults) over 2 years of age in the following conditions:
(1) Travelers or inhabitants of high-risk regions of the serogroup A, C, Y and W135 Neisseria meningitis epidemic areas like Sub-Saharan Africa.
(2) Persons who do laboratory or vaccine production work and might come in contact with the serogroupA, C, Y and W135 Neisseria meningitis in the air.
(3) High-risk population in the serogroups Y and W135 Neisseria meningitis epidemic areas estimated by the national Ministry of Health and CDC according to the epidemiological survey.
[Function and Use]
The vaccine is used against the epidemic cerebrospinal meningitis caused by Neisseria meningitides serogroup A, C, Y and W135.
Reconstituted as per labeled amount, each vial is 0.5ml, and 0.5ml for each human dose containing50μg of respective serogroup A, C, Y and W135 polysaccharide.
[Administration and Dosage]
(1) Reconstitute vaccine by adding the accompanying solvent into the vaccine to dissolve. Shake and inject immediately.
(2) The vaccine should be injected subcutaneously at deltoid insertion area of the lateral upper arm.
(3) Vaccinate a single 0.5ml dose before meningococcal epidemic season.
(4) Re-vaccination (recommended by foreign countries): one booster dose shall be given 2 ~3 years after the primary immunization to people who remain at risk of invasive meningococcal disease, especially to children who were younger than 4 years at the time of primary immunization. Though whether re-vaccination is necessary for older children and adults has not been determined, re-vaccination should be considered within 3~5 years after primary immunization in case that antibody levels rapidly decline within 2~3 years after vaccination.
There is no current information available on immune persistence and strengthening of immunization regarding this vaccine in clinical research.
Local adverse reactions: maily is injection site pain, then redness, swell and itching.
Systemic adverse reactions: mainly is fever, then headache, fatigue, drowsiness, nausea, vomiting and diarrhea, loss of appetite, muscle pain and rashes. Most of the adverse reactions can be relieved spontaneously and will disappear within 72 hours following vaccination.
The adverse reactions to this vaccine evaluated in domestic clinical studies with 900 subjects have been categorized as follows. The observation period was within 4 weeks after vaccination.
Adverse reactions (%) to Meningococcal Polysaccharide Vaccine Group ACYW135 after Vaccination
Nausea and vomiting Diarrhea
Loss of appetite
As with other vaccines, the present composition of this vaccine may cause allergic reactions in a minority of vaccinees, even the natural rubber stopper can cause an allergic reaction because the stopper of the vial contains dried natural rubber.
The vaccine should not be administered to subjects with the following conditions:
(1) Allergic to the vaccine or any components of the vaccine.
(2) Inpiduals with epilepsy, brain disorders and a history of allergy.
(3) Kidney disease, heart disease, active tuberculosis patients and persons infected with HIV.
(4) Subjects suffering from acute infectious diseases and fever.
(5) Since no reproductive toxicity test was performed on experimental animals or pregnant women, effects on the fetus is unknown. Therefore, vaccination to the pregnant women is prohibited, especially those within the first trimester of pregnancy.
(1)The vaccine should be used with caution in the following cases: Family and the inpidual has a history of seizures; patients with chronic disease, patients with a history of epilepsy, allergy sufferers, pregnant women and lactating women.
(2) Appropriate medical treatment and supervision must be available to manage possible rare adverse reactions following administration of the vaccine, such as epinephrine for first-aid of anaphylactic reaction. Observe for at least 30 minutes after vaccination.
(3) Prior to administration, inspect visually for cracks in the vial, loose stopper, or with abnormal appearance after reconstitution. If any of these conditions exist, the vaccine shall not be administered.
(4) Once reconstituted, the vaccine should be used up as per regulated dose. pided dosing is prohibited. In case of non-immediate use, storage time shall be no more than 30 minutes.
(5) Do not inject this product intradermally, intramuscularly or intravenously, for these three administration routes have not been evaluated for safety and efficacy by clinical research.
(6) To avoid the accumulation of the endotoxin level, the vaccine cannot be used with pertussis vaccine and typhoid vaccine at the same time.
(7) The vaccine may not elicit a protective immune response in subjects with immunodeficiency or person under going immunosuppressive therapies.
(8) The vaccine should not be used on those who have been infected with Neisseria meningitis, and cannot protect from cerebrospinal meningitis caused by other infections (incl. Neisseria meningitis group B).
(9) The short-term prophylaxis for infants and children younger than 2 years is not available, but it can provide short-term protection to infants older than 3 months against Neisseria meningitis group A.
(10) Just like other vaccines, vaccination with Meningococcal Polysaccharide Vaccine Group ACYW135 could not protect all susceptible inpiduals 100%.
(11) It is not known whether Meningococcal Polysaccharide Vaccine Group ACYW135 is excreted in human milk. Because many drugs are excreted in human milk, be cautious when administered to lactating woman.
[Storage]Store and ship at 2～8℃, protected from light.
[Packaging] Each single human dose contains 1 vial of lyophilized vaccine and 1 vial of solvent. 1dose/carton; 5 doses/carton.
[Shelf Life] 24 months.
[Product Standard] YBS00342015
[Product License No.] GYZZ S20090011
Name: Hualan Biological Bacterin Co., Ltd.
Address: Jia No.1-1, Hualan Ave., Xinxiang, Henan, China
Zip code: 453003
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