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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)

Primary Purpose

Encephalitis, Tick-Borne

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

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)

About this trial

This is an interventional prevention trial for Encephalitis, Tick-Borne

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Grieskirchnerstr.17
Untergraben 2
Dr. Ulrich Behre
Niepubliczny Zakład Opieki Zdrowotnej Ośrodek Zdrowia w Lipsku

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level greater than equal to (>=) 10 at 21-35 days after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 46 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 58 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 70 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 82 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 94 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 106 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level >=10 at 118 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Seropositivity rate was reported as percentage of participants with NT level >=10 at 21-35 days after the second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Secondary Outcome Measures

Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with ELISA level greater than (>) 126 vienna units per milliliter (VIE U/mL) at each blood sampling time point after first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Seropositivity rate was reported as percentage of participants with ELISA level >126 VIE U/mL at 21-35 days after second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Antibody against TBE booster vaccination was measured as geometric mean concentration (GMC) by ELISA level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.

Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Antibody against TBE booster vaccination was measured as GMC by ELISA level after the second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.

Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Antibody against TBE booster vaccination was measured as geometric mean titer (GMT) by NT level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.

Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Antibody against TBE booster vaccination was measured as GMT by NT level after second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.

Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

GMFR in antibody concentration from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.

Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)

GMFR in antibody titers from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.

Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Injection site reactions included swelling, induration, redness, injection site pain, tenderness, ecchymosis and hematoma. Systemic reaction included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, malaise and fatigue. Participants with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure.

Full Information

NCT ID

NCT00894686

First Posted

April 30, 2009

Last Updated

May 9, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00894686

Brief Title

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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

April 26, 2009 (Actual)

Primary Completion Date

May 10, 2017 (Actual)

Study Completion Date

May 10, 2017 (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 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.

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 4

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All subjects

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

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 Description

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

Primary Outcome Measure Information:

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

21-35 days after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

38 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

46 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

58 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

70 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

82 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

94 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

106 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

118 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Description

Time Frame

21-35 days after second TBE booster vaccination

Secondary Outcome Measure Information:

Title

Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination

Title

Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Description

Time Frame

21-35 days after second TBE booster vaccination

Title

Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination

Title

Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Description

Time Frame

21-35 days after second TBE booster vaccination

Title

Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Description

Time Frame

21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination

Title

Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Description

Time Frame

21-35 days after second TBE booster vaccination

Title

Description

Time Frame

Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination

Title

Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)

Description

Time Frame

Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination

Title

Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Description

Time Frame

From second booster vaccination up to 21-35 days after the vaccination

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eva-Maria Pöllabauer, MD

Organizational Affiliation

Baxter Healthcare Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Grieskirchnerstr.17

City

Oberösterreich

Country

Austria

Facility Name

Untergraben 2

City

Oberösterreich

Country

Austria

Facility Name

Dr. Ulrich Behre

City

Baden-Württemberg

Country

Germany

Facility Name

Niepubliczny Zakład Opieki Zdrowotnej Ośrodek Zdrowia w Lipsku

City

Zamosc

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

30928173

Citation

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.

Results Reference

derived

Links:

URL

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

Description

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Learn more about this trial

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)

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