Study of the Safety, Tolerability and Immune Response of... | NCT00311441

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

NCT00311441

Sponsor

Novartis

Status

Completed

Last Update Posted

Mar 17, 2008Estimated

Enrollment

300

Phase

Phase 4

Conditions

Encephalitis, Tick-Borne

Interventions

Tick-Borne Encephalitis vaccine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
911

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 3, 2006

First Submission Date that Met QC Criteria

Apr 3, 2006

First Posted Date

Apr 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2008

Last Update Posted Date

Mar 17, 2008Estimated

Name	Class
Novartis Vaccines	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
Tick-Borne Encephalitis vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.

Secondary Outcomes

Measure	Description	Time Frame
Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female children, 1 to 10 years of age.

Exclusion Criteria:

Subjects with documented evidence of TBE
Subjects, who have been previously vaccinated against TBE

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Drug Information Services	Novartis Vaccines & Diagnostics	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D004675	Encephalitis, Tick-Borne

Ancestor Terms

ID	Term
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections

Browse Leaves

Not provided

Browse Branches

Not provided