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: Completed Phase 4 study of Fever, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent of participants for whom study procedures were completed successfully (prophylactic medication administered, temperature measured, memory aid completed, venipunctures performed)
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 |
What the finished NCT01946594 record still lists
NCT01946594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 597-participant average among 18 other Fever trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Where NCT01946594's enrollment target sits among peer trials
41 16th of 18 higher than 3 of 18 other Fever trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fever trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03449238 · 41 participants · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
- NCT03900793 · 41 participants · Phase 1
Losartan + Sunitinib in Treatment of Osteosarcoma
- NCT04082520 · 41 participants · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
- NCT04220190 · 41 participants · Phase 2
RAPA-501 Therapy for ALS
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia