The Effect of Extended Yellow Fever Vaccine Information o... | NCT00708630

Studies
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination

NCT00708630

Sponsor

University of Auckland, New Zealand

Status

Completed

Last Update Posted

Jul 30, 2012Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Vaccination

Interventions

Extended information on side effects

Countries

New Zealand

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

Status Module

Record Verification Date

Jul 2012

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

Jun 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jun 27, 2008

First Submission Date that Met QC Criteria

Jul 1, 2008

First Posted Date

Jul 2, 2008Estimated

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

Jul 26, 2012

Last Update Posted Date

Jul 30, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Keith J Petrie, Professor, University of Auckland, New ZealandPrincipal Investigator

Lead Sponsor

University of Auckland, New ZealandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the effect of providing additional information about possible mild side effects of the yellow fever vaccination on the reporting of physical symptoms. Additionally, the project aims to investigate the relationship between individual characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of physical symptoms, as well as possible interactions between the level of information provided and individual characteristics. We hypothesize that more information about mild symptoms provided to participants will increase the number of reported symptoms after vaccination.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Provision of extended symptom side effects information	Behavioral: Extended information on side effects
2	No Intervention	Standard information on side effects

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extended information on side effects	Behavioral	More detailed information on possible side effects of vaccine	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
symptom report scale		20 minutes and 1 week post vaccination

Secondary Outcomes

Measure	Description	Time Frame
patient satisfaction scale		20 minutes and 1 week post vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Receiving yellow fever vaccination
English speaker
Aged over 18

Exclusion Criteria:

No phone for follow-up

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith J Petrie, PhD	University of Auckland, New Zealand	Principal Investigator
Kate E Faasse, BSc	University of Auckland, New Zealand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Worldwise Travellers Health		Auckland	Auckland	10021	New Zealand

Condition Browse Module

MeSH Terms

ID	Term
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided