Breeding chickens imported from the USA, adopt the dedicated system of raw materials with high quality and guarantee the product quality from the very beginning.
Up to 2011, vaccination person-times was over 19,000,000, the safety and validity are verified sufficiently.
|0.5 mL/vial||0.5 mL/ syringe||0.25 mL/ syringe|
In order to evaluate the safety and immunogenicity of its Influenza Vaccine (Split Virion), Inactivated, HulanBio authorized the Jiang Provincial Center for Disease Control and Prevention (CDC) as the main investigator from May 2006~Oct. 2006 to conduct a parallel blind control clinical study of the influenza vaccine in healthy populations older than 6 months of age.
Serologic testing report issued by the National Institutes for the Control of Pharmaceutical and Biological Products (NICPBP) showed that: the influenza vaccine of HualanBio had a good immunogenicity performance. There was no significantly statistical difference on seroconversion ratios and protective rates after immunization between the experimental and control vaccines. The product quality complied with international criteria.
Safety and immunological effect of domestic split influenza virus vaccine
ZHANG Pei-ru﹡,ZHU Xiao-ping,ZHOU Liang-jun,LIU You-quan , FAN Ya,CHEN Guo,CHEN Zhi,LIU Yan, SUN Hong-ying, WU Jian-lin,﹡Mianyang Center for Disease Control and Prevention,Mianyang 621000,China
Corresponding author：ZHOU Liang-jun
[Abstract] Objective To evaluate the safety and immunological effect of domestic split influenza virus vaccine. Methods 606 subjects were divided into three groups by under 6, 16—60 and above 60 years old. Each age group was divided as study group(n=213), control group I (n=195) and control group II(n=198) by Table of Random Number, one domestic vaccine and two imported vaccines were respectively inoculated in three group people. The differences of clinical side effect rate, antibody positive rate, protective rate and geometric mean titer (GMT) of these three vaccines were compared by using the statistical software with statistical significance of P<0.05. Results The side effect rate of study group, control group I and control group II was 3.76%(8/213), 4.10%(8/195), and 3.54%(7/198), respectively without statistical significance(χ2=0.87,P =0.93). The positive seroconversion rates of H1N1, H3N2 and B in these three groups were respectively 89.0％(190/213), 63.2％(135/213), 86.6％(184/213),88.9％(173/195), 61.7％(120/195), 87.2％(170/195),88.0％(174/198), 61.7％(122/198)and 84.7％(168/198). There were not statistical significance in the total positive seroconversion rate of each antibody type(χ2H1N1=0.94,P H1N1=0.63；χ2H3N2 =0.94,P H3N2=0.63；χ2B =0.75,PB =0.69). The average growth multiple of H1N1, H3N2 and B in these three groups were 10.7, 7.3, 8.4, 10.5, 6.3, 8.3, 10.2, 7.1, 8.8 times. There were no statistical significances in the GMT growth multiple of each antibody type (FH1N1=0.35,PH1N1=0.70；FN3N2=2.22,PN3N2=0.11；FB=1.51,PB=0.35). The antibody protective rates of H1N1, H3N2 and B were 100％(213/213),70.0％(149/213),95.3％(203/213),100％(195/195),66.7％(130/195),97.8％(191/195),99.5％(197/198),66.1％(131/198),96.7％(191/198)respectively. There was no statistical difference among the three vaccines(χ2H1N1=2.04,PH1N1=0.36；χ2H3N2 =0.74,PH3N2=0.69；χ2B =0.42,PB =0.82). Connclusion The domestic influenza split vaccine might be suitable for colony vaccination for its clinical safety and immunological effect.
[Key Words]Influenza vaccines; Safety; Evaluation studies
2. The first manufacturer in China to apply for WHO Pre-qualification.
3. The world-leading production equipment, high standard primary package material, without sub batch.
4. No thiomersal, no antibiotic.
5. The independent and complete cold chain transportation system.
Huanlan Bio is a key national high-tech company in China engaging in the research, development, production, and commercialization of biological products, e.g.: blood product, vaccine, genetic engineering, etc. At present, Hualan has built the most advanced production line of influenza vaccine with the largest capacity in China. In 2010, Hualan had 10,920,000 doses of influenza vaccines passed the national lot release. Output of the seasonal influenza vaccine of Hualan was about 20 million doses in the recent three years, leading the industry in China.
HualanBio extended its quality management to chicken selection and chose HY-LINE VARIETY WHITE from the HY-LINE INTERNATIONAL in USA as the egg source after strict quarantine and screening, which is characterized by lower endotoxin content in eggs compared with other chickens. Hualan is the only vaccine manufacturer in China building high-standard chicken house itself and manufacturing influenza vaccine using eggs without immunization and antibiotics, which complies with quality specifications of the EU. Hualan obtains eggs with stable quality via carefully raising and strict management, thereby guarantee the quality of product from the very beginning.
Hulan purchased advanced machines from other countries, e.g.: the Automatic Virus Inoculation Machine, the Automatic Allantoic Fluid Harvesting Machine, the High Speed Filling and Packaging Equipment, etc., which makes it the first manufacturer in China meeting the international standard. Hualan selected imported prefilled syringes that are not only convenient for use but also cause slight injection pain. They can guarantee vaccines are stable and highly efficient and avoid iatrogenic contamination so as to ensure safety of users. The filling speed is 36,000 vials/hour, filling precision is high and aseptic control is much more scientific. All these make vaccine production without sub batches is possible.
Hualan has established transit logistics stations in Beijing, Suzhou, Chongqing and Guangzhou with modernized cold rooms of several thousand m2 installed and dozens of refrigerator cars equipped so as to provide service for the transportation of biological products. Those stations adopt the GPS Management System of Cold-chain Transportation developed by the GLP Software Management Company in USA to realize the monitoring of temperature and location of product at any time during the transportation.
The elderly older people than 60 years
Patients with chronic diseases or weak populations
Staff in medical organizations, especially in the frontline
Pupils and children in kindergarten
Staff in the rest room, elderly care center and kindergarten
Employees engaging in the service industry, especially taxi drivers, crews in civil airline, railway and highway communication systems; employees engaging in the commerce industry and employees engaging in the travel service
People who usually go out for business trips or travel abroad
Generic Name: Influenza Vaccine (Split Virion), Inactivated
English Name: Influenza Vaccine (Split Virion), Inactivated
Chinese Pinyin: Liugan Bingdu Liejie Yimiao
[Constituents and Characters]
The vaccine is prepared from influenza virus type A and B prevalent strains recommended by WHO. The virus strains are propagated in embryonated chicken eggs. After incubation ,the virus suspensions in allantoic cavities are harvested. The vaccine is prepared by inactivation, concentration, purification and splitting. The vaccine is a slightly opalescent liquid.
Active ingredients: Hemagglutinin of prevalent strains of influenza virus in current year. The vaccine 0.5ml contains:
A/California/7/2009(H1N1)pdm09-like virus…. …………….... .15μɡ hemagglutinin
A/Hong Kong/4801/2014(H3N2)-like virus……………………...15μɡ hemagglutinin
B/Brisbane/60/2008-like virus…………..………………………..15μɡ hemagglutinin
Excipients: Na2HPO4, NaH2PO4, NaCl.
The vaccine is approved for use in vulnerable people and high risk population for inf1uenza complications, such as children over 3 years of age, the elderly, the weak and people in influenza epidemic areas.
[Function and Use]
It is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine for prophylaxis of the Influenza caused by the contained vaccine strain.
This vaccine per single human dose is 0.5ml in vial containing not lower than 15µg HA for each virus strain.
[Administration and Dosages]
(1) Intramuscularly inject the vaccine in the region of the deltoid muscle of the upper arm.
(2) Persons 3 years of age and older should vaccinate with a single dose of 0.5 ml before or during the flu epidemic season.
Common Adverse Reactions:
(1) Pain, tenderness, redness, swelling, and pruritus at the injection site may appear in a few subjects within 24 hours post-vaccination. Normally it will disappear in two or three days.
(2) A few subjects would have transient fever after vaccination, but it will disappear without treatment in a short period.
Rare Adverse Reactions:
(1) Transient cold symptoms and general malaise may occur, but will vanish without special treatment.
(2) Severe febrile reaction: Physical method and symptomatic treatment should be adopted to avoid febrile convulsion.
(3) Rare neuralgia, paresthesia, convulsion, and transient thrombocytopenia.
Very rare Adverse Reactions:
(1) Anaphylactoid dermatitis: Hives may appear within 72 hours post-vaccination. In this case, anti-anaphylactic treatment should be given immediately.
(2) Anaphylactoid purpura: Cortisol should be given immediately for anti-anaphylactic treatment to people who have anaphylactoid purpura post vaccination. Anaphylactic purpura nephritis may complicate if the anaphylactoid purpura could not timely treated or properly treated.
(3) Anaphylactic shock: may occur within 1 hour after vaccination. Adrenaline should be available for first aid in case of severe anaphylactic reactions.
(4) Encephalomyelitis, neuritis and Guillain-Barre Syndrome.
(1) Subjects with known hypersensitivity reactions to any components of the vaccine, including eggs, excipients, formaldehyde, Triton X-100.
(2) Subjects who have acute illness, severe chronic diseases, acute exacerbation of chronic disease and fever.
(3) Pregnant women.
(4) Subjects with a diagnosis of uncontrolled epilepsy or other nervous system progressive disease, and history of Guillain-Barre Syndrome.
(1) The vaccine should be administered with caution in inpiduals with a history of convulsions, chronic disease, epilepsy or allergies.
(2) If either of these conditions exists, the vaccine should not be administered. Any leakage of container or illegible label or any clumps not dispersed after shaking in the container.
(3) Use immediately once the container is opened.
(4) The vaccine should be used within the shelf life stated on the label.
(5) Adrenaline should be available for first aid in case of severe anaphylactic reactions. The recipients should take a rest for at least 30 minutes on site after vaccination.
(6) Revaccination is prohibited if any neurological reaction occurs after vaccination.
(7) Subjects treated with immunoglobulin shall defer for at least one month for the vaccination with this vaccine.
(8) Immunocompromised subjects or those who have any questions before use should consult and comply with the medical advice.
(9) Do not be freezed or partially used.
(10) Intravenous injection of the vaccine is strictly contraindicated.
Should the vaccine be administered simultaneously with another injectable vaccine(s), the vaccine(s) would be administered at different injection sites.
Immunosuppressive therapies may influence the immune response to influenza. Consult the healthcare provider to prevent possible interactions with other drugs.
[Storage] Store and ship at 2-8°C, protected from light.
[Packaging] Glass tubing vial, sealed with bromobutyl rubber stopper.
1 vial per carton. 5 vials per carton.10 vials per carton.
[Shelf Life] 12 months
[Product Standard]YBS00112011 and Chinese Pharmacopoeia (volume Ⅲ,2015 edition)
[Product License No.] GYZZ S20083016
Hualan Biological Bacterin Co., Ltd.
Address: Jia No.1-1, Hualan Ave., Xinxiang, Henan, China
Post Code: 453003
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