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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00708630




Registration number
NCT00708630
Ethics application status
Date submitted
27/06/2008
Date registered
2/07/2008
Date last updated
30/07/2012

Titles & IDs
Public title
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination
Scientific title
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination
Secondary ID [1] 0 0
KPKF001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccination 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Extended information on side effects

Experimental: 1 - Provision of extended symptom side effects information

No intervention: 2 - Standard information on side effects


BEHAVIORAL: Extended information on side effects
More detailed information on possible side effects of vaccine
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
symptom report scale
Timepoint [1] 0 0
20 minutes and 1 week post vaccination
Secondary outcome [1] 0 0
patient satisfaction scale
Timepoint [1] 0 0
20 minutes and 1 week post vaccination

Eligibility
Key inclusion criteria
* Receiving yellow fever vaccination
* English speaker
* Aged over 18
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* No phone for follow-up

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00708630
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith J Petrie, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00708630