Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
Japanese encephalitis virus (Live, attenuated, recombinant)
ZUELLIG PHARMA PTE. LTD.
J07BA03
4.0-5.8 log PFU/dose
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Japanese encephalitis virus (Live, attenuated, recombinant) 4.0-5.8 log PFU/dose
SUBCUTANEOUS
Prescription Only
GLOBAL BIOTECH PRODUCTS CO. LTD. (For powder and diluent)
ACTIVE
2014-12-12
1 NAME OF THE MEDICINE IMOJEV ® POWDER AND DILUENT* FOR SUSPENSION FOR INJECTION JAPANESE ENCEPHALITIS VACCINE (LIVE, ATTENUATED) *0.4% Sterile Sodium chloride solution DESCRIPTION IMOJEV ® is a monovalent, live attenuated viral vaccine. The virus was obtained via recombinant DNA technology. It is based on the 17D-204 yellow fever vaccine virus in which two genes have been replaced by the corresponding genes from Japanese encephalitis (JE) virus. These are the premembrane (prM) and envelope (E) coding sequences of the SA14-14-2 live attenuated JE vaccine virus. The immunising antigens are the prM and E proteins from the SA14-14-2 vaccine virus. AFTER RECONSTITUTION: ACTIVE INGREDIENTS: Live, attenuated, recombinant Japanese encephalitis virus*: 4.0 – 5.8 log PFU** per dose (0.5 mL) * Propagated in Vero cells ** Plaque Forming Unit EXCIPIENTS: Mannitol, lactose, glutamic acid, potassium hydroxide, histidine, Human Serum Albumin, sodium chloride and water for injections. No adjuvant or microbial preservative is added. The powder is a white to creamy white homogeneous cake which might be retracted from the sides of the vial. The diluent is a clear solution. After reconstitution, IMOJEV ® is a colourless to amber suspension. PHARMACOLOGY MECHANISM OF ACTION The vaccine is a live attenuated virus. Following administration, the virus replicates locally and elicits neutralising antibodies and cell-mediated immune responses that are specific to the Japanese encephalitis (JE) virus. Available results indicate that protection is mainly mediated by neutralising antibodies. In nonclinical studies, all animals that received a single dose of the vaccine developed specific neutralising antibodies against JE virus and were protected against infecti Przeczytaj cały dokument
In the phase III trial, approximately 67% of toddlers who did not receive any JE vaccine before the single dose administration of IMOJEV® are still seroprotected 5 years after the vaccination. All the toddlers included in this trial with serological data available 28 days after the vaccination were seroprotected at this timepoint. Table 6 shows the immune response against the homologous virus strain, up to 5 years after vaccination with a single dose of IMOJEV®. TABLE 6: IMMUNE RESPONSE UP TO 5 YEARS AFTER A SINGLE-DOSE OF IMOJEV® IN TODDLERS (12 TO 18 MONTHS) NOT PREVIOUSLY IMMUNISED WITH A JE VACCINE AND SEROPROTECTED 28 DAYS AFTER THE SINGLE-DOSE In another Phase III trial in infa nts and toddlers (9 to 18 months) not previously immunized with a JE vaccine, approximately 88% of individuals were still seroprotected 1 year after the single dose administration of IMOJEV®. TABLE 7: IMMUNE RESPONSE 6 MONTHS AND 1 YEAR AFTER A SINGLE DOSE OF IMOJEV® IN INFANTS AND TODDLERS (9 TO 18 MONTHS) NOT PREVIOUSLY IMMUNISED WITH A JE VACCINE In a Phase III trial, a second dose (booster dose) of IMOJEV® was administered in children (36 to 42 months of age) (N = 340) 24 months after primary vaccination with IMOJEV®. A control group of children (36 to 42 months of age) (N = 39) who never received a JE vaccine, received IMOJEV® for the first time to characterise the primary response to IMOJEV®. The Geometric Mean Titre (GMT) increased by nearly 6 fold from Day 0 to Day 7 after the administration of IMOJEV® in children previously vaccinated. By comparison, the GMT did not increase in the control group, thus demonstrating an anamnestic response in the booster group. The GMT increased by nearly 57 fold from Day 0 to Day 28 in the booster group. 100% of children previously vaccinated with IMOJEV® showed seroprotective antibody titres 28 days after the administration of the booster dose 24 months after primary vaccination. Table 8 shows the immune response against the homologous virus strain, 7 and 28 days after administrat Przeczytaj cały dokument