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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...

Update Il y a 5 ans
Reference: EUCTR2006-001676-21

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 immunization

Woman and Man

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Extract

Descriptive evaluation of subjects with respect to antibody titers and percentage of subjects with neutralizing antibodies on Day 0 (i.e., day of first booster immunization after primary immunization in study V48P7 for subjects who did not get a booster immunization, or day of first blood draw for those who did receive a booster dose), on Day 21 (+7 days) and Year 1, 2, 3, 4, and 5 (± 30 days each) after booster immunization with Novartis Vaccines' (ex Chiron’s) TBE vaccine for adults as measured by Neutralization Test (NT, in-house, Novartis Vaccines). Subjects who have already received a booster immunization before this study, will only provide blood samples on Day 0 and Year 1, 2, 3, 4, and 5 (± 30 days each) thereafter

Inclusion criteria

  • TBE prophylaxis

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