Safety and Long-term Evaluation (up to 5 Years) of First... | NCT00387634

NCT00387634

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator	Blood draw only, no vaccine	Biological: TBE vaccine for adults
Arm 2	Active Comparator	Blood draw only, no vaccine	Biological: TBE vaccine for adults
Arm 3	Active Comparator	Blood draw only, no vaccine	Biological: TBE vaccine for adults
Arm 4	Active Comparator	Blood draw only, no vaccine	Biological: TBE vaccine for adults

Name	Type	Description	Arm Group Labels	Other Names
TBE vaccine for adults	Biological	Serology blood draw.	Arm 1 Arm 2 Arm 3 Arm 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA		On day 21, year 1, year 2, year 3, year 4, year 5

Secondary Outcomes

Measure	Description	Time Frame
safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting		Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines - Information Services	Novartis	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24950352	Derived	Beran J, Xie F, Zent O. Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety. Vaccine. 2014 Jul 23;32(34):4275-80. doi: 10.1016/j.vaccine.2014.06.028. Epub 2014 Jun 17.