A phase IV, open-label, single-center study in adolescents and adults: Evaluation of immunogenicity and safety of the first booster immunization with Chiron’s TBE vaccine for adults in participants of study V48P7 and long-term evaluation of immunogenicity up to 5 years after first booster immunizatio

• Conditions: TBE prophylaxis; MedDRA version: 8.1Level: LLTClassification code 10043847Term: Tick-borne viral encephalitis

• Registration Number: EUCTR2006-001676-21-CZ
• Lead Sponsor: ovartis Vaccines and Diagnostics GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-23
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

- healthy subjects who/whose parents/legal representative signed informed consent prior to study entry
- subjects who have completed study V48P7
- subjects who are in good health as determined by medical history, physical examination, and clinical judgment of the investigator

Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- subjects with acute disease at the day of booster immunization (acute disease means moderate or severe illness with or without fever. All vaccines can be administered to subjects with minor illness such as mild diarrhea or mild upper respiratory tract infection with oral temperature < 38.0°C.)*
- subjects in whom a general decrease in resistance might be expected, e.g. those who have recently sustained major injury or undergone recent major surgical operations, are undernourished, or have disorders involving a decreased immune response
- subjects:
a) with organic brain disturbances, including seizure disorders*
b) with progressive neurological disorders
c) who have suffered febrile or afebrile convulsions*
d) with major congenital defects
e) with serious chronic illness (such as insulin dependent diabetes, cancer, autoimmune diseases)
f) with evidence of hypersensitivity to the study vaccine or chemically related substances in their medical history*
- subjects being treated with:
a) immunosuppressants or systemic corticosteroids within the past 4 weeks or during the study period, except short term use of topic corticosteroids
b) immunoglobulins, whole blood or plasma derivates up to 3 months before enrollment
- subjects who have received another vaccine within 4 weeks before the administration of the study vaccine *
- subjects enrolled in another investigational, clinical study at the same time or within the last 3 months
- women who are pregnant (in case of uncertainty, pregnancy should be excluded by a pregnancy test) *
- women of childbearing age who refuse to use an effective method of birth control (abstinence, oral or injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent, intrauterine device) beginning 28 days before study entry and continuing through 28 days after the immunization*

* Only apply to subjects receiving booster immunization

Study & Design

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