TBE SEROPERSISTENCE AFTER FIRST BOOSTER IN CHILDREN (FOLLOW-UP TO STUDY 700401)

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2009-009324-36-PL
• Date of registration: 11/03/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: TBE SEROPERSISTENCE AFTER FIRST BOOSTER IN CHILDREN (FOLLOW-UP TO STUDY 700401)
• Scientific 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) - TBE SEROPERSISTENCE AFTER FIRST BOOSTER IN CHILDREN (FOLLOW-UP TO STUDY 700401)
• Date of first enrolment: 05/05/2009
• Target sample size: 202
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009324-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, Germany, Poland

Contacts

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects who participated in 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 Study 700401;
•Blood was drawn after the first booster vaccination in 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).

Are the trial subjects under 18? yes
Number of subjects for this age range: 202
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects who participated in 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 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 Study 700401;
•Subject is known to be HIV positive (a special HIV test is not required for the purpose of the study) since his / her first booster vaccination in Study 700401;
•Subject received a blood product or immunoglobulins within 90 days before the blood draw or in the period between 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active (prophylactic) immunization against TBE 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 Study 700401.
MedDRA version: 18.0 Level: PT Classification code 10043847 Term: Tick-borne viral encephalitis System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: FSME-IMMUN 0.25 ml Junior
Product Name: FSME-IMMUN 0.25 ml Junior
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: J07 BA01
CAS Number: 8000029723
Current Sponsor code: PF-06830414
Other descriptive name: TBE Virus Antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1.2-

Trade Name: FSME-IMMUN 0.5 ml
Product Name: FSME-IMMUN 0.5 ml
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: J07 BA01
CAS Number: 8000029723
Current Sponsor code: PF-06830414
Other descriptive name: TBE Virus Antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.4-

Primary Outcome(s)

Primary end point(s): Immunogenicity:
Seropositivity rate as determined by NT at each blood draw after the first booster vaccination administered in Study 700401 and after the second booster vaccination administered in this study

Secondary Objective: To assess the antibody response to a second booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml administered in the present study, by means of ELISA and NT.
To assess the safety of FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml after administration of the second booster vaccination in the present study.

Timepoint(s) of evaluation of this end point: End of trial

Main Objective: The main purpose of this study is to assess the seropersistence at yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination (as applicable) with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml by means of neutralization test (NT) (according to Adner et ak., 2001) and ELISA (IMMUNOZYM FSME Immunoglobulin G [IgG].

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Blood draws will be performed to assess the seropersistence of TBE virus antibodies at yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination previously administered during Study 700401.A blood draw will be performed approximately 21 - 35 days after vaccination to assess the booster response.

Secondary end point(s): Seropositivity rate as determined by ELISA at each blood draw after the first booster vaccination
in Study 700401 and after the second booster vaccination in this study;
Antibody response as determined by ELISA at each blood draw after the first booster vaccination
in Study 700401 and after the second booster vaccination in this study;
Antibody response as determined by NT at each blood draw after the first booster vaccination in
Study 700401 and after the second booster vaccination in this study;
Fold increase of antibody concentration determined by ELISA after the second booster vaccination
as compared to before the second booster vaccination in this study;
Fold increase of antibody titer determined by NT after the second booster vaccination as compared
to before the second booster vaccination in this study.

Secondary ID(s)

2009-009324-36-AT

B9371021_(Formerly_Baxter_700802)

Source(s) of Monetary Support

Pfizer Inc