assess the immunogenicity, safety and interchangeability of two tick-borne encephalitis (TBE) vaccines in children aged 1-11 years MedDRA version: 9.1 Level: LLT Classification code 10043847 Term: Tick-borne viral encephalitis
Conditions
Interventions
Trade Name: FSME-IMMUN 0.25 ml Junior
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: J07 BA01
CAS Number: 8000029723
Other descriptive name: TBE VIRUS ANTIGEN
Concentration unit: m
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: they are aged > 1 years (from the first birthday) to 11 years (to the last day before the 12 th birthday) their parents/legal guardians provide written informed consent children provide written assent to the study according to age and capacity of understanding their parents/guardians understand the nature of the clincial trial ans will comply with the requirements of the protocol (e.g. completion of the subject diary, return for follow-up visits) are generelly healthy, (i.e the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical trial) show a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: they have a history of any previous TBE vaccination they have a history of TBE infection they have a history of infection with other flaviviruses they have a history of vaccination against yellow fever and/or Japanese B-encephalitis they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions they have received any blood product or immunoglobulin within 90 days prior to study entry they are known to be HIV positive (an HIV test is not required specifically for the purpose of this study) they have a functional or surgical asplenia they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product they are pregant or breastfeeding (if a femal subject) they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study. Subjects who suffer from an acute illness with or without elevated body temperature (=37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated until their body temperature returns to normal. In this case the first vacciantion will be given at a separate visit at a later date, so long as the center is still open for recruitment. If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later dae, so long as the cener is stillopen for recruitment. Subjects who received any live vaccine within 4 weeks or any inactivated vaccine within 2 weeks prior to the scheduled first study vaccination will not be vaccinated until an interval of 4 or 2 weeks, respectively, has passed, provided the center is still open for recruitment. If a subject had a tick bite within 4 weeks before the scheduled first or second vaccination, the vaccination shall be postponed until an interval of 4 weeks has passed. Subjects who are determined to have previously been exposed to the TBE virus (as demonstrated by ELISA IMMUNOZYM: > 126 VIE U/ml or ELISA ENZYGNOST: >10.32 U/ml, and/or NT = 1:10 at baseline) will be included in the study, but will be excluded for the assessment of immunoge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years with the first and second vaccination with either FSME IMMUN 0,25 ml or Encepur 0,25 ml children and the third vaccination with FSME IMMUN 0,25 ml only, administered according the conventional schedule (0, 28 and 360 days). Primary Endpoint Immunogenicity: Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination.;Secondary Objective: Immunogenicity: Seropositivity rate determined by NT 180 days after the 1st vaccination and 28 days after the 3 rd vacciantion. Seropositivity rate determined by ELISA and antibody response measured by NT and ELISA 28 days after the 2 nd vaccination and 180 days after the 1st vaccination and 28 days after the 3 rd vaccination. Fold increase of antibody response measured by NT and ELISA 28 days after the 2 nd vaccination and 180 days after the 1st vaccination and 28 days after the 3 rd vaccination as compared to baseline. Safety: Frequency and severity of injection site reactions occuring after each vaccination. Frequency and severity of systemic reactions occuring after each vaccination. Frequency and severity of adverse experiences (AEs) observed during the entire follow-up period for each study group.;Primary end point(s): Immunogenicity: Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination | — |
Countries
Austria, Czech Republic
Outcome results
None listed