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

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.

Completed

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Key information

Conditions

Encephalitis, Tick-borne Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Tick-Borne Diseases Vector Borne Diseases Virus Diseases

Age range

6 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Wiener Strasse 50/2, Kapfenberg, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Biological

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 1998
Study completion: 1999
First posted: Sep 13, 2005
Registry last updated: May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed