Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01946594 · ClinicalTrials.gov registry record · Phase 4
Clinical Immunization Safety Assessment (CISA) Project: Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After IIV
A Phase 4 study of Fever, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT01946594 is a Phase 4 study of Fever that has completed, run by Duke University. The registered enrollment target is 41 participants, below the 597-participant average among 18 other Fever trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01946594, a Phase 4 study of Fever, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
The study team aims to conduct a double-blind, placebo-controlled, pilot study to assess the effect of prophylactic antipyretics on the immune responses and rates of fever after inactivated influenza vaccine (IIV) in children 12 through 35 months of age. In this pilot, 40 healthy children, 12 through 35 months of age, including some children at risk of febrile seizure, will be randomized to receive prophylactic acetaminophen or oral placebo immediately following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study. Feasibility will include assessments of the speed and ease of study recruitment and adherence to and completion of study assessments. 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 day following vaccination. Antibody to influenza antigens contained in the 2013-2014 vaccine 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 reactions, 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 receiving acetaminophen and placebo. Likewise geometric mean HAI titers (GMT) and corresponding 95% confidence intervals for each IIV antigen will be calculated for both vaccine groups.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Acetaminophen
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01946594
The ClinicalTrials.gov registry entry for NCT01946594 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 597-participant average among 18 other Fever trials with a reported enrollment target (93% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fever appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01946594 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01946594 about?
NCT01946594 is a clinical study titled "Clinical Immunization Safety Assessment (CISA) Project: Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After IIV". The study team aims to conduct a double-blind, placebo-controlled, pilot study to assess the effect of prophylactic antipyretics on the immune responses and rates of fever after inactivated influenza vaccine (IIV) in children 12 through 35 months of age. In this pilot, 40 healthy children, 12 throug...
What is the current status of trial NCT01946594?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2013-10. Estimated completion is 2014-03.
What conditions does trial NCT01946594 study?
This clinical trial studies the following conditions: Fever.
What interventions are being tested in trial NCT01946594?
The interventions under investigation include: Placebo (OTHER), Acetaminophen (OTHER).
Who is sponsoring clinical trial NCT01946594?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01946594 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fever
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Safety of RSV Preventive Monoclonal Antibody
RECRUITING · Phase 4
-
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
COMPLETED · Phase 4
-
Temperature Control in Central Fever in the Neuro-ICU
COMPLETED · Phase 4
-
Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
COMPLETED · Phase 4
-
TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
RECRUITING · NA
-
Remote Temperature Monitoring of Patients At Risk for Developing Fever
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.