A phase IV clincal study to evaluate antibody responses through 6 to 10 yearsafter after first booster with TBE vaccine.

Phase 1

• Conditions: o medical condition, healthy subjects.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-003255-19-CZ
• Lead Sponsor: GlaxoSmithKline Biologicals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-26
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.subjects who signed informed consent form (ICF) prior to study entry
2.subjects who have completed study V48P7E1 and who received in a parent V48P7 study one of the following schedules: rapid (R), conventional (C), or accelerated conventional (AC).
3.subjects who are in stable health as determined by medical history, physical examination, and clinical judgment of the investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 201
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.who are unwilling or unable to give written informed consent to participate in the study.
2.who are perceived to be unreliable or unavailable for the duration of the study period.
3.who has NT titer below 10 before visit 17 (first study visit within this protocol).
4.who has received a TBE or other flavivirus vaccine after completion of the V48P7E1 and before starting V48P7E2 study.
5.who had a previous confirmed TBE infection or were exposed (documented infection) to other flaviviruses.
6.who received in the parent V48P7 study a primary immunization according to the modified conventional (MC) schedule.
7.who have received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
8.who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study.
9.who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
10.who have chronic immunosuppressive conditions
11.who have been treated with:
-immunosuppressants or systemic corticosteroids within the past 4 weeks or during the study period, except short term use of topical corticosteroids
-immunoglobulins, whole blood or plasma derivatives up to 3 months before enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified