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NCT02212990 · ClinicalTrials.gov registry record · NA
The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 104
- Enrollment target
NCT02212990 is a NA study that has completed, run by Duke University. The registered enrollment target is 104 participants.
The verdict
NCT02212990, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 104 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo Arm
- OTHER Acetaminophen Arm
- OTHER Ibuprofen Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02212990
The ClinicalTrials.gov registry entry for NCT02212990 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Arm is the first listed.
NCT02212990 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02212990 about?
NCT02212990 is a clinical study titled "The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine". 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...
What is the current status of trial NCT02212990?
This trial is currently completed. It is a NA study. The enrollment target is 104 participants. The study started on 2014-09. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02212990?
The interventions under investigation include: Placebo Arm (OTHER), Acetaminophen Arm (OTHER), Ibuprofen Arm (OTHER).
Who is sponsoring clinical trial NCT02212990?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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