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Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Unterer Graben 2
Eferding, Upper Austria, 4070 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-Borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-11 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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 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.

NCT00840801
Pfizer
Completed
Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

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Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Encephalitis, Tick-Borne
  • Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
    Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
  • Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
    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.
  • Experimental: 1
    Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
    Intervention: Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
  • Experimental: 2
    Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
    Intervention: Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
August 2010
May 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Year to 11 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic
 
 
NCT00840801
700801
EUDRACT NUMBER: 2008-002691-10
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Principal Investigator: Baxter Bioscience Investigator Baxter BioScience
Pfizer
May 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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