|
View: |
Part 1: Document Description
|
|
Citation |
|
|---|---|
|
Title: |
Data for: Non- inferiority fractional-doses trial for yellow fever vaccine (NIFTY Trial) |
|
Identification Number: |
doi:10.7910/DVN/YBRX8I |
|
Distributor: |
Harvard Dataverse |
|
Date of Distribution: |
2024-01-31 |
|
Version: |
2 |
|
Bibliographic Citation: |
Warimwe, George M.; Kimathi, Derick; Cheruiyot, Stanley; Bejon, Philip, 2024, "Data for: Non- inferiority fractional-doses trial for yellow fever vaccine (NIFTY Trial)", https://doi.org/10.7910/DVN/YBRX8I, Harvard Dataverse, V2, UNF:6:Zw1UGT8lKZDq60RW8Com4Q== [fileUNF] |
|
Citation |
|
|
Title: |
Data for: Non- inferiority fractional-doses trial for yellow fever vaccine (NIFTY Trial) |
|
Identification Number: |
doi:10.7910/DVN/YBRX8I |
|
Authoring Entity: |
Warimwe, George M. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
|
Kimathi, Derick (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Cheruiyot, Stanley (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Bejon, Philip (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Distributor: |
Harvard Dataverse |
|
Access Authority: |
Warimwe, George M. |
|
Access Authority: |
The Data Governance Committee |
|
Depositor: |
Warimwe, George M. |
|
Date of Deposit: |
2024-01-31 |
|
Holdings Information: |
https://doi.org/10.7910/DVN/YBRX8I |
|
Study Scope |
|
|
Keywords: |
Medicine, Health and Life Sciences, Yellow Fever, Vaccine, Fractional doses |
|
Abstract: |
<p>The NIFTY trial sought to determine whether reducing the dosage of the vaccine can provide the same protection to the standard dosage given in Kenyan and Ugandan adults and children. The trial is registered at <a href="">ClinicalTrials.gov. ID: NCT04059471</a>.</p> <p>This dataset relates to a trial to determine the safety and immune response elicited by the reduced doses of yellow fever vaccine in comparison to full dose of the vaccine in Kenyan and Ugandan adults. This was a parallel group, randomized, controlled, blinded, non-inferiority trial of four different doses of YF vaccine. The study was conducted at the KEMRI CGMRC in Kilifi, Kenya and at Epicentre in Mbarara, Uganda. Both these sites had already worked together in study (Clinicaltrials.gov number: NCT02991495).Adult participants (n=480) was randomized for vaccination with full standard dose or with 1000,500 or 250 IU (i.e. 4 arms) with a 1:1:1:1 allocation ratio. Adult vaccinees was followed up for 2 years. This data was captured in paper Case report forms(CRFs) stored in secure lockable cabinets by study clinicians and later transcribed into eCRFs using REDCap database by data entry clerks located at each site. Data export to create analysis was done using STATA statistical software.</p> |
|
Kind of Data: |
Restricted Access |
|
Kind of Data: |
Clinical Trial |
|
Notes: |
<strong>Data Access</strong> <p>Access to these data requires submission of a formal request for consideration by our Data Governance Committee. </p> <strong>How to request</strong> <ol> <li>Download and complete the <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx"><strong>data request form</strong></a></li> <li> Email completed data request form to the Data Governance Committee at <a href="mailto:dgc@kemri-wellcome.org?cc=lmwango@kemri-wellcome.org?Subject=Data%20Access%20Request"><strong>dgc@kemri-wellcome.org</strong></a> </li> </ol> |
|
Methodology and Processing |
|
|
Sources Statement |
|
|
Data Access |
|
|
Notes: |
Access to the dataset is restricted. Accompanying documentation is available under open access. For more detailed information beyond the metadata and documentation provided, there is a process of managed access requiring submission of a request form for consideration by our Data Governance Committee [dgc@kemri-wellcome.org].<strong> <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx">Click to download Data Request Form</a></strong> |
|
Other Study Description Materials |
|
|
File Description--f8145374 |
|
|
File: NIFTY_Adults_anon-1.tab |
|
|
|
|
Notes: |
UNF:6:+xQFgnvtlZSupTZOsOcHrA== |
|
File Description--f8145375 |
|
|
File: NIFTY_Adults_anon.tab |
|
|
|
|
Notes: |
UNF:6:ZSZzCfOIz/hOQCWc5yJLew== |
|
Label: |
CRFs V1_ PDF.zip |
|
Notes: |
application/zip |
|
Label: |
NIFTY Adults _ REDCap_codebook2.pdf |
|
Notes: |
application/pdf |
|
Label: |
NIFTY Protocol Version 1.3 04032019_final.pdf |
|
Notes: |
application/pdf |
|
Label: |
NIFTY_Adults_dataset_Readme.txt |
|
Notes: |
text/plain |