Product |
FSME-IMMUN® |
Encepur TM |
EnceVir |
TBE-Moscow |
Manufacturer |
Baxter Vaccines, Vienna, Austria |
Novartis Vaccines and Diagnostics, Germany |
Virion Corporation, Tomsk, Russia |
Chumakov Institute for Poliomyelitis and Viral Encephalitides, Moscow, Russia |
Virus strain (subtype) |
Neudörfl (European subtype) |
K-23 (European subtype) |
205 (Far-Eastern subtype) |
Sofjin (Far-Eastern subtype) |
Production method |
Cultured in primary chicken embryo cells, purified after formaldehyde inactivation by continuous-flow zonal centrifugation |
Cultured in primary chicken embryo cells, purified after formaldehyde inactivation by continuous-flow zonal centrifugation. |
Cultured in primary chicken embryo cells, purified and concentrated after formaldehyde inactivation; treated with
protamine sulfate. |
Cultured in primary chicken embryo cells, purified and concentrated after formaldehyde inactivation; treated with protamine sulfate. Lyophilized in excipient. |
Excipients |
Aluminium hydroxide, human serum albumin. |
Aluminium hydroxide, sucrose. |
Aluminium hydroxide, human serum albumin (250μg/dose). |
Aluminium hydroxide (final formulation), human albumin (500μg/ dose), gelatin and sucrose. |
Distributed product |
Stored as liquid formulation in pre-filled syringe. |
Stored as liquid formulation in pre-filled syringe. |
Stored as liquid formulation. |
Lyophilized in excipient, mixed with saline containing aluminium hydroxide just prior to administration. |
Shelf life (2-8°C) |
|
|
2 years |
3 years |
Countries licensed |
Austria, Germany, Switzerland, Hungary, Czech Republic, Baltic States, UK, Canada |
Germany, Austria, Switzerland, Czech Republic, Baltic States, Russia |
Russia |
Russia |
Pediatric vaccine
|
1 to < 16 years old |
1 to < 12 years old |
Formulation is licensed for all persons >3 years old. |
Formulation is licensed for all persons >3 years old. |
Vaccination schedule
Conventional: |
0, 1-3 months, 6-15 months
Booster doses for adults as per 2005 Austrian Immunization Plan:
< 60 years: first booster after 3 years, subsequently 5-year intervals
≥ 60 years: 3-year intervals
Booster doses for children per manufacturer: 3-year intervals |
0, 1-3months, 10-15 months
Booster doses for adults as per 2005 Austrian Immunization Plan:
< 60 years: first booster
after 3 years, subsequently
5-year intervals
≥ 60 years: 3-year intervals
Booster doses for children
per manufacturer:
1st boost at 3-year interval then at 5 year intervals |
0, 5-7 months
First booster 12 months after second dose, then boosters every 3 years. |
0, 1-7 months
First booster 12 months after second dose, then boosters every 3 years. |
Vaccination schedule
Accelerated: |
Day 0, day 14, 6-15 months
booster doses: as above |
Two schedules available:
A. Day 0, day 14, 10-15 months. Booster doses as above
B. Day 0, 7, 21
First booster at 12-18 months, subsequent booster doses as above |
0, 1-2 months
First booster 12 months after second dose, then boosters every 3 years. |
0, 1 month
First booster 12 months after second dose, then boosters every 3 years. |
Immunogenicity
(seroconversion)
Conventional
schedule: |
Adults:
92.9%-97% after second dose,
100% after third dose
Children:
98.5%-100% after second
dose, 100% after third dose |
Adults:
100% after second dose
Children:
95-99% after second dose, 100% after 3rd dose |
Adults:
82-89% after second dose
Children:
84-97% after second
dose |
Adults:
84-93% after second dose
Children:
89-96% after second
dose |
Immunogenicity
(seroconversion)
Accelerated
schedule: |
Adults:
clinical trials not available
Children:
95% after second dose |
Adults:
100% after primary series
(3 doses)
Children:
100% after primary series
(3 doses) |
NA |
NA |
Safety |
Mild-moderate systemic and local reactions common
Fever in very young children common
Fever in older children occasional
Fever in adults infrequent
Severe neurologic reactions very rare |
Large scale randomized trials have not been published
Moderate reactigenicity identified in small scale trials
In 2010-2011, some lots of EnceVir associated with frequent high fever and allergic reactions in children. EnceVir subsequently removed from pediatric use. |
