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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02212990
Other study ID # Pro00056213
Secondary ID 200-2012-53663
Status Completed
Phase N/A
First received August 7, 2014
Last updated February 5, 2018
Start date September 2014
Est. completion date March 2016

Study information

Verified date April 2016
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to conduct a double-blind, placebo-controlled study to assess the effect of prophylactic antipyretics on the immune responses and rates of fever after inactivated influenza vaccine (IIV) in children 6 through 47 months of age.

In this study, 160 healthy children, 6 through 47 months of age, including some children at risk of febrile seizure, will be randomized to one of three different treatment arms. Children will receive either blinded therapy with prophylactic acetaminophen or placebo immediately following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV or open-label ibuprofen every 6 to 8 hours in the 24 hours after receipt of a dose of IIV. Children will be followed for the occurrence of fever, fussiness, changes in appetite and sleep patterns, and use of medical services on the day of and for two days following vaccination. Antibody to influenza antigens contained in the respective 2014-2015 and 2015-2016 vaccines as measured by hemagglutination inhibition (HAI) antibody will be assessed at baseline and four weeks following vaccination. The proportions of children experiencing fever, having solicited side effects, using medical services, demonstrating a serologic response corresponding to seroprotection and seroconversion to each of the IIV antigens will be determined for groups of children in each of the three treatment arms. Likewise geometric mean HAI titers (GMTs) and corresponding 95% confidence intervals for each IIV antigen will be calculated for the three treatment arms. The investigators hope to learn whether or not prophylactic antipyretics affect the immune response and fever rates following IIV.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acetaminophen Arm
Blinded Therapy
Placebo Arm
Blinded Therapy
Ibuprofen Arm
Open Label Therapy

Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Fever Proportions of children with fever (= 38°C and = 39°C) on days 0, 1, and 2 following IIV Days 0, 1, and 2 following IIV
Other Systemic symptoms following IIV Proportions of children with fussiness, appetite change, or altered sleep on days 0, 1, and 2 following IIV Days 0, 1, and 2 following IIV
Other Receipt of medical attention Proportions of children receiving medical attention on days 0, 1, and 2 following IIV Days 0, 1, and 2 following IIV
Primary Seroconversion Seroconversion (an HAI titer = 1:40 four weeks post- vaccination if the baseline titer is < 1:10 or a four-fold rise in HAI titer if the baseline titer is = 1:10) for each IIV antigen One month following the last dose of IIV
Secondary Seroprotection Seroprotection (the proportion of subjects with an HAI titer >1:40) to each IIV antigen One month following the last dose of IIV
Secondary Geometric mean HAI titer Geometric mean HAI titer (GMT) and 95% confidence interval for each IIV antigen One month following the last dose of IIV
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