A Study to Evaluate long-term immunogenicity in subjects boosted with a new pediatric TBE vaccine (free of protein-derived stabilizer) In children and adolescents
- Conditions
- Prophylaxis: Tick-borne-encephalitisTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-005105-20-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines and Diagnostics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 232
Individuals meeting all of the following criteria were eligible for enrollment into the study:
Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.
Informed consent was obtained for all the subjects before enrollment into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 232
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
In this study subjects who received a booster immunization since termination of study V48P4E2 were not excluded. They were asked to consent that the information of the booster immunization could be implemented in the database for statistical reason and to use the serum samples of previous studies for avidity determination.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method