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

NCT ID: NCT00894686

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-26
• Study Completion Date: 2017-05-10

Brief Summary

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.

Conditions

Encephalitis, Tick-Borne

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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)

Intervention Type: BIOLOGICAL

Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Eva-Maria Pöllabauer, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Locations

Grieskirchnerstr.17

Oberösterreich, , Austria

Untergraben 2

Oberösterreich, , Austria

Dr. Ulrich Behre

Baden-Württemberg, , Germany

Niepubliczny Zakład Opieki Zdrowotnej Ośrodek Zdrowia w Lipsku

Zamość, , Poland

Countries

Austria; Germany; Poland

References

Poellabauer E, Angermayr R, Behre U, Zhang P, Harper L, Schmitt HJ, Erber W. Seropersistence and booster response following vaccination with FSME-IMMUN in children, adolescents, and young adults. Vaccine. 2019 May 27;37(24):3241-3250. doi: 10.1016/j.vaccine.2019.03.032. Epub 2019 Mar 27.

Reference Type: DERIVED

PMID: 30928173 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=700802&StudyName=Open-label%20Phase%20Iv%20Study%20To%20Investigate%20The%20Seropersistence%20Of%20Tick-borne%20Encephalitis%20%28tbe%29%20Virus%20Antibodies%20After%20The%20First%20Booster%20And%20The%20Response%20To%20A%20Second%20Booster%20Vaccination%20With%20Fsme-immun%20In%20Children%2C%20Adolescents%20And%20Young%20Adults%20%28follow-up%20To%20Study%20700401%29

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Other Identifiers

B9371021

Identifier Type: OTHER

Identifier Source: secondary_id

2009-009324-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

700802

Identifier Type: -

Identifier Source: org_study_id