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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Wiener Strasse 50/2
Kapfenberg, , 8605 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-47 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00161746
Pfizer
Completed
Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

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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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Encephalitis, Tick-borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 1999
Not Provided

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
Sexes Eligible for Study: All
6 Months to 47 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00161746
146A
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
Pfizer
May 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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