Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Primary Purpose
Encephalitis, Tick-Borne
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Sponsored by
About this trial
This is an interventional prevention trial for Encephalitis, Tick-Borne
Eligibility Criteria
Inclusion Criteria:
Male and female children will be eligible for participation in this study if:
- they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;
- 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 clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
- they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
- provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).
Exclusion Criteria:
Subjects will be excluded from participation if:
- 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 are suffering 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 immunoglobulins within 90 days prior to study entry;
- they are known to be Human Immunodeficiency Virus (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 pregnant or breastfeeding (if a female 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 have 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. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature < 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) 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 date, as long as the center is still open 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 was bitten by a tick within 4 weeks prior to the scheduled first or second vaccination, the vaccination must be postponed until an interval of 4 weeks has passed.
Sites / Locations
- Unterer Graben 2
- Grieskirchnerstr.17
- Private surgery of General Practitioner for children and juveniles
- University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
- Chemiku 129
- Private surgery of General Practitioner for children and juveniles
- Private surgery of General Practitioner for children and juveniles
- Private surgery of General Practitioner for children and juveniles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
Outcomes
Primary Outcome Measures
Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination
Secondary Outcome Measures
Seropositivity rate determined by NT 180 days after the first vaccination and 28 days after the third vaccination
Seropositivity rate determined by ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination
Antibody response measured by NT/ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination
Fold increase of antibody response measured by NT/ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination as compared to baseline
Frequency and severity of injection site reactions/systemic reactions occurring after each vaccination
Frequency and severity of adverse experiences (AEs) observed during the entire follow-up period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00840801
Brief Title
Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Official Title
Single-blind, Randomized, Phase 3B Study in Children Aged 1 - 11 Years to Investigate the Immunogenicity, Safety and Interchangeability of Two Tick-borne Encephalitis (Tbe) Vaccines Administered According to a Conventional Schedule
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Tick-Borne
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
Arm Title
2
Arm Type
Experimental
Arm Description
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
Intervention Type
Biological
Intervention Name(s)
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention Description
Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
Intervention Type
Biological
Intervention Name(s)
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention Description
Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.
Primary Outcome Measure Information:
Title
Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Seropositivity rate determined by NT 180 days after the first vaccination and 28 days after the third vaccination
Time Frame
28, 180 days
Title
Seropositivity rate determined by ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination
Time Frame
28, 180 days
Title
Antibody response measured by NT/ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination
Time Frame
28, 180 days
Title
Fold increase of antibody response measured by NT/ELISA 28 days after the second vaccination, 180 days after the first vaccination and 28 days after the third vaccination as compared to baseline
Time Frame
28, 180 days
Title
Frequency and severity of injection site reactions/systemic reactions occurring after each vaccination
Time Frame
28 days
Title
Frequency and severity of adverse experiences (AEs) observed during the entire follow-up period
Time Frame
388 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female children will be eligible for participation in this study if:
they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;
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 clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).
Exclusion Criteria:
Subjects will be excluded from participation if:
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 are suffering 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 immunoglobulins within 90 days prior to study entry;
they are known to be Human Immunodeficiency Virus (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 pregnant or breastfeeding (if a female 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 have 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. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature < 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) 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 date, as long as the center is still open 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 was bitten by a tick within 4 weeks prior to the scheduled first or second vaccination, the vaccination must be postponed until an interval of 4 weeks has passed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter Bioscience Investigator
Organizational Affiliation
Baxter BioScience
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unterer Graben 2
City
Eferding
State/Province
Upper Austria
ZIP/Postal Code
4070
Country
Austria
Facility Name
Grieskirchnerstr.17
City
Wels
State/Province
Upper Austria
ZIP/Postal Code
4600
Country
Austria
Facility Name
Private surgery of General Practitioner for children and juveniles
City
Havlickuv Brod
ZIP/Postal Code
580 01
Country
Czech Republic
Facility Name
University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Chemiku 129
City
Pardubice-Polabiny
ZIP/Postal Code
530 09
Country
Czech Republic
Facility Name
Private surgery of General Practitioner for children and juveniles
City
Pardubice
ZIP/Postal Code
530 02
Country
Czech Republic
Facility Name
Private surgery of General Practitioner for children and juveniles
City
Pardubice
ZIP/Postal Code
530 03
Country
Czech Republic
Facility Name
Private surgery of General Practitioner for children and juveniles
City
Pardubice
ZIP/Postal Code
530 09
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
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