Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161746

Enrollment

Unknown

Registered

2005-09-13

Start date

1998-04-30

Completion date

1999-06-30

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalitis, Tick-borne

Keywords

Tick-Borne Encephalitis

Brief summary

The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.

Interventions

BIOLOGICALTick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Months to 47 Months

Healthy volunteers

Yes

Inclusion criteria

* Male and female children aged between 6 and 47 months * No history of any previous TBE vaccination * Clinically healthy * Informed consent provided by the parents

Exclusion criteria

* History of allergic reactions, in particular allergic reactions to one of the components of the vaccine * Suffering from a disease that cannot be effectively treated or stabilised * Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions * Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system * HIV-positivity (no special HIV test required for the purpose of the study) * Suffering from a febrile disease * History of vaccination against yellow fever and/or Japanese encephalitis * Participation in another clinical trial

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026