Bock 1990.
| Methods |
Design: randomized controlled trial Generation of allocation sequence: not described Allocation concealment: not described Blinding: single blind Inclusion of all randomized participants in the analysis: none lost to follow up Length of follow up: 56 days |
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| Participants |
Number: 56 healthy male aged 20 to 50 years Inclusion criteria: not reported Exclusion criteria: not reported |
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| Interventions |
Vaccine: Encepur Dose‐finding study: 1. 0.03 μg, 6 participants 2. 0.18 μg, 5 participants 3. 0.35 μg, 18 participants 4. 1.00 μg, 16 participants 5. 3.00 μg, 11 participants Schedule: 2 inoculations on days 0 and 28 at 5 different dosages in 0.5 mL |
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| Outcomes | 1. Geometric means of tick‐borne encephalitis (TBE) antibody titres 28 days after second inoculation (as assayed by enzyme‐linked immunosorbent assay (ELISA), haemagglutination inhibition test, and neutralization test): minimum, median, and maximum values 2. Reactogenicity assessed by medical check‐up on vaccination day, 2 days later and for a follow‐up period of 28 days after each injection: local and systemic "Adverse Drug Events" (ADEs) |
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| Notes | Location: Germany | |