search
Back to results

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

Primary Purpose

Vaccination

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Extended information on side effects
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vaccination focused on measuring yellow fever vaccine, patient information, symptom reports, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No phone for follow-up

Sites / Locations

  • Worldwise Travellers Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Provision of extended symptom side effects information

Standard information on side effects

Outcomes

Primary Outcome Measures

symptom report scale

Secondary Outcome Measures

patient satisfaction scale

Full Information

First Posted
June 27, 2008
Last Updated
July 26, 2012
Sponsor
University of Auckland, New Zealand
search

1. Study Identification

Unique Protocol Identification Number
NCT00708630
Brief Title
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination
Official Title
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination
Keywords
yellow fever vaccine, patient information, symptom reports, patient satisfaction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Provision of extended symptom side effects information
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard information on side effects
Intervention Type
Behavioral
Intervention Name(s)
Extended information on side effects
Intervention Description
More detailed information on possible side effects of vaccine
Primary Outcome Measure Information:
Title
symptom report scale
Time Frame
20 minutes and 1 week post vaccination
Secondary Outcome Measure Information:
Title
patient satisfaction scale
Time Frame
20 minutes and 1 week post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Receiving yellow fever vaccination English speaker Aged over 18 Exclusion Criteria: No phone for follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith J Petrie, PhD
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kate E Faasse, BSc
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Worldwise Travellers Health
City
Auckland
ZIP/Postal Code
10021
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs