IMOJEV® POWDER AND DILUENT FOR SUSPENSION FOR INJECTION

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Japanese encephalitis virus (Live, attenuated, recombinant)

זמין מ:

ZUELLIG PHARMA PTE. LTD.

קוד ATC:

J07BA03

כמות:

4.0-5.8 log PFU/dose

טופס פרצבטיות:

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

הרכב:

Japanese encephalitis virus (Live, attenuated, recombinant) 4.0-5.8 log PFU/dose

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

Prescription Only

תוצרת:

GLOBAL BIOTECH PRODUCTS CO. LTD. (For powder and diluent)

מצב אישור:

ACTIVE

תאריך אישור:

2014-12-12

עלון מידע

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genes have been 
replaced by the corresponding genes from Japanese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

מאפייני מוצר

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