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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00840801
First received: February 9, 2009
Last updated: August 2, 2010
Last verified: August 2010
  Purpose

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).


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Seropositivity rate as determined by neutralization test (NT) 28 days after the second vaccination [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seropositivity rate determined by NT 180 days after the first vaccination and 28 days after the third vaccination [ Time Frame: 28, 180 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency and severity of injection site reactions/systemic reactions occurring after each vaccination [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse experiences (AEs) observed during the entire follow-up period [ Time Frame: 388 days ] [ Designated as safety issue: Yes ]

Enrollment: 302
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
Experimental: 2
Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
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.

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840801

Locations
Austria
Unterer Graben 2
Eferding, Upper Austria, Austria, 4070
Grieskirchnerstr.17
Wels, Upper Austria, Austria, 4600
Czech Republic
Private surgery of General Practitioner for children and juveniles
Havlickuv Brod, Czech Republic, 580 01
University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
Hradec Králové, Czech Republic, 50005
Private surgery of General Practitioner for children and juveniles
Pardubice, Czech Republic, 530 03
Private surgery of General Practitioner for children and juveniles
Pardubice, Czech Republic, 530 02
Private surgery of General Practitioner for children and juveniles
Pardubice, Czech Republic, 530 09
Chemiku 129
Pardubice-Polabiny, Czech Republic, 530 09
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter Bioscience Investigator Baxter BioScience
  More Information

No publications provided

Responsible Party: Jael Wiertz, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00840801     History of Changes
Other Study ID Numbers: 700801, EUDRACT NUMBER: 2008-002691-10
Study First Received: February 9, 2009
Last Updated: August 2, 2010
Health Authority: Austria: Federal Office for Safety in Health Care
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 26, 2014