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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

1999-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

NCT00163618

Encephalitis, Tick-borne

COMPLETED

Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

NCT00840801

Encephalitis, Tick-Borne

COMPLETED PHASE3

Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

NCT00161772

Tick-borne Encephalitis

COMPLETED PHASE2

TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)

NCT00161967

Encephalitis, Tick-Borne

COMPLETED PHASE4

Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

NCT00311441

Encephalitis, Tick-Borne

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Encephalitis, Tick-borne

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes