Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
17 July 2017 |
Main ID: |
EUCTR2009-009324-36-AT |
Date of registration:
|
16/02/2009 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
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:
|
04/03/2009 |
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
|
Address:
|
235 E 42nd Street
NY 10017
New York
United States |
Telephone:
|
+1800 712 1021 |
Email:
|
ClinicalTrials.govCallCentre@pfizer.com |
Affiliation:
|
Pfizer Inc |
|
Name:
|
Clinical Trials.gov Call Centre
|
Address:
|
235 E 42nd Street
NY 10017
New York
United States |
Telephone:
|
+1800 712 1021 |
Email:
|
ClinicalTrials.govCallCentre@pfizer.com |
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: jTBE Virus Antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.4-
|
Primary Outcome(s)
|
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 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.
|
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 Outcome(s)
|
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.
|
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 ID(s)
|
B9371021_(Formerly_Baxter_700802)
|
Source(s) of Monetary Support
|
Pfizer Inc
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|