Trials Sponsors Conditions Drugs Pricing

Conditions

Encephalitis, Tick-Borne

Outcome Measures

Primary Outcomes (1)

Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
Percentage of participants achieving NT titer greater than or equal to (\>=) 10.
28 days after Vaccination 2

Secondary Outcomes (14)

Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
180 days after the Vaccination 1, 28 days after the Vaccination 3
Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3

Study Arms (2)

1

EXPERIMENTAL

Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

2

EXPERIMENTAL

Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Biological

Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Biological

Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.

Eligibility Criteria

Age1 Year - 11 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Male and female children will be eligible for participation in this study if:
they are aged \>= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (8)

Unterer Graben 2

Eferding, Upper Austria, 4070, Austria

Grieskirchnerstr.17

Wels, Upper Austria, 4600, Austria

Private surgery of General Practitioner for children and juveniles

Havlíčkův Brod, 580 01, Czechia

University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581

Hradec Králové, 50005, Czechia

Private surgery of General Practitioner for children and juveniles

Pardubice, 530 02, Czechia

Private surgery of General Practitioner for children and juveniles

Pardubice, 530 03, Czechia

Private surgery of General Practitioner for children and juveniles

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus Infections

Results Point of Contact

Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR
Baxter Bioscience Investigator
Baxter BioScience
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

302 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

February 6, 2009

Actual (reported)

You may not qualify if:

Subjects will be excluded from participation if:
they have a history of any previous TBE vaccination;
they have a history of TBE infection;
they have a history of infection with other flaviviruses;
they have a history of vaccination against yellow fever and/or Japanese B encephalitis;
they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;
they are suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
they have received any blood product or immunoglobulins within 90 days prior to study entry;
they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study);
they have a functional or surgical asplenia;
they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation;
they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product;
they are pregnant or breastfeeding (if a female subject);
they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
Subjects who have an acute illness with or without elevated body temperature (\>=37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature \< 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) the center is still open for recruitment.
+3 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations