The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination - Full Text View

Sponsored by:	University of Auckland, New Zealand
Information provided by:	University of Auckland, New Zealand
ClinicalTrials.gov Identifier:	NCT00708630

Purpose

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.

Condition	Intervention
Vaccination	Behavioral: Extended information on side effects

MedlinePlus related topics: Fever

Drug Information available for: Yellow Fever Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination

Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:

symptom report scale [ Time Frame: 20 minutes and 1 week post vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

patient satisfaction scale [ Time Frame: 20 minutes and 1 week post vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Provision of extended symptom side effects information	Behavioral: Extended information on side effects More detailed information on possible side effects of vaccine
2: No Intervention Standard information on side effects	Behavioral: Extended information on side effects More detailed information on possible side effects of vaccine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Receiving yellow fever vaccination
English speaker
Aged over 18

Exclusion Criteria:

No phone for follow-up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708630

Contacts

Contact: Kate E Faasse, BSc	64-9373-7599 ext 86561	k.faasse@auckland.ac.nz
Contact: Keith J Petrie, PhD	64-9373-7599 ext 86564	kj.petrie@auckland.ac.nz

Locations

New Zealand
Worldwise Travellers Health	Recruiting
Auckland, New Zealand, 10021
Principal Investigator: Kate E Faasse, BSc

Sponsors and Collaborators

University of Auckland, New Zealand

Investigators

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

More Information

Responsible Party:	University of Auckland ( Professor Keith J Petrie )
Study ID Numbers:	KPKF001
Study First Received:	June 27, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00708630
Health Authority:	New Zealand: Health and Disability Ethics Committees

Keywords provided by University of Auckland, New Zealand:

yellow fever vaccine
patient information
symptom reports
patient satisfaction

Study placed in the following topic categories:

Virus Diseases
Fever
Yellow Fever
Yellow fever
Arbovirus Infections

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009