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

NCT ID: NCT00708630

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Vaccination

Keywords

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yellow fever vaccine patient information symptom reports patient satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Provision of extended symptom side effects information

Group Type EXPERIMENTAL

Extended information on side effects

Intervention Type BEHAVIORAL

More detailed information on possible side effects of vaccine

2

Standard information on side effects

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Extended information on side effects

More detailed information on possible side effects of vaccine

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Receiving yellow fever vaccination
* English speaker
* Aged over 18

Exclusion Criteria

* No phone for follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Auckland, New Zealand

OTHER

Sponsor Role lead

Responsible Party

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Keith J Petrie

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith J Petrie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, New Zealand

Kate E Faasse, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, New Zealand

Locations

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Worldwise Travellers Health

Auckland, Auckland, New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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KPKF001

Identifier Type: -

Identifier Source: org_study_id