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NCT00708630 Clinical Trial

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

Vaccination Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00708630
Other study ID # KPKF001
Secondary ID
Status Completed
Phase N/A
First received June 27, 2008
Last updated July 26, 2012
Start date June 2008
Est. completion date December 2008

Study information
Verified date July 2012
Source University of Auckland, New Zealand
Contact n/a
Is FDA regulated No
Health authority New Zealand: Health and Disability Ethics Committees
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Receiving yellow fever vaccination

- English speaker

- Aged over 18

Exclusion Criteria:

- No phone for follow-up

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Behavioral:
• Extended information on side effects
More detailed information on possible side effects of vaccine

Locations
Country Name City State
New Zealand Worldwise Travellers Health Auckland

Sponsors (1)
Lead Sponsor Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary symptom report scale 20 minutes and 1 week post vaccination No
Secondary patient satisfaction scale 20 minutes and 1 week post vaccination No
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