Tick-Borne Encephalitis (TBE) Seropersistence After First Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00894686
First received: April 30, 2009
Last updated: July 11, 2016
Last verified: June 2016
  Purpose
The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.

Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open-label Phase Iv Study To Investigate The Seropersistence Of Tick-borne Encephalitis (Tbe) Virus Antibodies After The First Booster And The Response To A Second Booster Vaccination With Fsme-immun In Children, Adolescents And Young Adults (Follow-up To Study 700401)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Seropositivity rate determined by neutralization test (NT) after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seropositivity rate determined by ELISA after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ] [ Designated as safety issue: No ]
  • Antibody response determined by ELISA after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ] [ Designated as safety issue: No ]
  • Antibody response determined by neutralization test (NT) after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study [ Time Frame: At yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination ] [ Designated as safety issue: No ]
  • Fold increase of antibody concentration determined by ELISA after the second booster vaccination as compared to before the second booster vaccination in this study [ Time Frame: 21-35 days after the booster vaccination ] [ Designated as safety issue: No ]
  • Fold increase of antibody concentration determined by neutralization test (NT) after the second booster vaccination as compared to before the second booster vaccination in this study [ Time Frame: 21-35 days after the booster vaccination ] [ Designated as safety issue: No ]
  • Injection site reactions observed in the period from the second booster vaccination until the following blood draw [ Time Frame: 21-35 days after the booster vaccination ] [ Designated as safety issue: Yes ]
  • Systemic reactions observed in the period from the second booster vaccination until the following blood draw [ Time Frame: 21-35 days after the booster vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 202
Study Start Date: April 2009
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All subjects
Assessment of seropersistence of TBE antibodies at yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination (in Study 700401), as well as antibody response to a second booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL, depending on the subject´s age. Timing of the second booster vaccination will depend on the level of serum TBE antibodies detected at the defined assessment time points. Subjects who are not protected against TBE for an entire further season (NT titer <= 20 and/or ELISA value < 126 VIE U/mL) will be invited to receive the second booster vaccination at either the 40, 48, 60, 72, 84, 96, 108, or 120-month time point.
Biological: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)
Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study:

  • Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);
  • Subject provides written assent to the study according to age and capacity of understanding;
  • Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;
  • Blood was drawn after the first booster vaccination in precursor Study 700401;
  • Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).

Exclusion Criteria:

Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:

  • Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401;
  • Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401;
  • Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study);
  • Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable);
  • Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages);
  • Subject / parent(s) / legal guardian(s) is / 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 the site conducting the study.
  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: NCT00894686

Locations
Austria
Untergraben 2
Eferding, Austria, 4070
Grieskirchner Straße 17
Weise, Austria, 4600
Germany
Gemeinschaftspaxis Dr. Ulrich Behre
Kehl, Germany, 77694
Poland
Niepubliczny ZOZ
Zamosc, Poland, 22400
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Eva-Maria Pöllabauer, MD Baxter Healthcare Corporation
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00894686     History of Changes
Other Study ID Numbers: 700802  B9371021  2009-009324-36 
Study First Received: April 30, 2009
Last Updated: July 11, 2016
Health Authority: Austria: Federal Ministry for Health Family and Youth
Germany: Paul-Ehrlich-Institut
Poland: Ministry of Health

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016