NCT00840801

Brief Summary

The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2010

Completed
13.7 years until next milestone

Results Posted

Study results publicly available

January 19, 2024

Completed
Last Updated

January 19, 2024

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

February 9, 2009

Results QC Date

June 6, 2022

Last Update Submit

April 19, 2023

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

  • +9 more secondary outcomes

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

1

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;
  • their parents / legal guardians provide written informed consent;
  • children provide written assent to the study according to age and capacity of understanding;
  • their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
  • they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
  • provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unterer Graben 2

Eferding, Upper Austria, 4070, Austria

Location

Grieskirchnerstr.17

Wels, Upper Austria, 4600, Austria

Location

Private surgery of General Practitioner for children and juveniles

Havlíčkův Brod, 580 01, Czechia

Location

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

Hradec Králové, 50005, Czechia

Location

Private surgery of General Practitioner for children and juveniles

Pardubice, 530 02, Czechia

Location

Private surgery of General Practitioner for children and juveniles

Pardubice, 530 03, Czechia

Location

Private surgery of General Practitioner for children and juveniles

Pardubice, 530 09, Czechia

Location

Chemiku 129

Pardubice-Polabiny, 530 09, Czechia

Location

Related Links

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 InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

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

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

Primary Completion

May 20, 2010

Study Completion

May 20, 2010

Last Updated

January 19, 2024

Results First Posted

January 19, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

More information

Locations

AU(2)CZ(6)