FeverPhase 4NCT01946594
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 testing Acetaminophen in people with Fever, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be eligible for inclusion in the study the following enrollment criteria must be met:
- The child must be 12 through 35 months of age.
- The child must only need a single dose of IIV during the current season. (Children only need 1 dose of vaccine in 2013-14 if they received a total of 2 or more doses of seasonal vaccine since July 1, 2010. Children who did not receive a total of 2 or more doses of seasonal vaccine since July 1, 2010 require 2 doses in 2013-14).[19]
- The parent/guardian must be willing and capable of providing written informed consent for the child.
- The parent/guardian must be available for follow-up and must at minimum have telephone access.
- The parent/guardian must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed).
Who cannot join
- Participants must not have any of the following:
- History of receipt of current year's licensed influenza vaccine.
- History of a severe allergic reaction (e.g. anaphylaxis) to any component of influenza vaccine, including egg protein, formaldehyde, octylphenol ethoxylate, gelatin, or thimerosal if using thimerosal containing vaccine.
- History of a severe allergic reaction (e.g. anaphylaxis) following a prior dose of influenza vaccine.
- History of an allergic reaction following acetaminophen or ingredients in the acetaminophen product.
- History of an allergic reaction following ibuprofen or ingredients in the ibuprofen product.
Show all 17Show fewer
- History of liver disease.
- Currently taking the blood thinning drug warfarin (Coumadin).
- Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study or expects to receive a licensed vaccine during the 28 days following the last vaccination in this study. Concomitant vaccinations are not allowed.
- Routine immunizations are delayed or will be delayed by not being able to receive a concomitantly administered vaccine or a needed vaccine in the 28 days following receipt of the influenza vaccine.
- Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to vaccination in this study, or expects to receive an experimental/investigational agent within the follow-up time period (28 days after the last vaccination in this study).
- A moderate to severe acute illness and/or a reported temperature greater than or equal to 100.0°F (37.8°C) within 72 hours prior to first dose of IIV or an axillary temperature greater than or equal to 100.0°F (37.8°C) at the time of enrollment. (This may result in a temporary delay of vaccination).
- Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours prior to the first dose of IIV (This may result in a temporary delay of vaccination) or is already planning to administer a prophylactic antipyretic medication on the day of and the day following IIV (this exclusion does not apply if the caretaker indicates he/she might administer antipyretics after vaccination to reduce a fever).
- Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
- Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other glucocorticoid), any parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (topical and nasal steroids are allowed).
- History of Guillain-Barré syndrome within 6 weeks of a prior dose of influenza vaccine.
- Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Rates of Fever After 2013-2014 Inactivated Influenza Vaccine (IIV) in Young Children
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
- Fever
- Being tested
- Acetaminophen, Placebo
- Keywords
- fever, antipyretics, acetaminophen, influenza vaccine, influenza, human, body temperature changes, Orthomyxoviridae Infections, RNA virus infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
- Medical subject headings
- Fever, Influenza, Human, Body Temperature Changes, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen Arm | Active comparator | Acetaminophen Suspension 160 mg / 5 mL:
Oral dose immediately following IIV and every 4-6 hours up to 24 hours (Maximum 5 oral doses) Receives: Other: Acetaminophen |
| Placebo Arm | Placebo comparator | Placebo Suspension:
Oral dose immediately following IIV and every 4-6 hours up to 24 hours (Maximum 5 oral doses) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of study procedures
Percent of participants for whom study procedures were completed successfully (prophylactic medication administered, temperature measured, memory aid completed, venipunctures performed)
Measured: 1 month
Secondary outcomes (1)
Immune Response to IIV
Immune responses (hemagglutination inhibition assay) to IIV in each group (proportion of subjects demonstrating seroprotection and seroconversion and geometric mean titer)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Emmanuel B Walter, MD, Principal investigator, Duke UniversityKaren Broder, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946594
- Sponsor's protocol ID
- Pro00048541
- Other IDs
- 200-2012-53663
- Status last verified
- Jan 2016
- First submitted
- 17 Sep 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Rates of Fever After 2013-2014 Inactivated Influenza Vaccine (IIV) in Young Children
- ClinicalTrials.gov ID
- NCT01946594
- Acronym / sponsor ID
- Pro00048541
- Conditions
- Fever
- Keywords
- fever, antipyretics, acetaminophen, influenza vaccine, influenza, human, body temperature changes, Orthomyxoviridae Infections, RNA virus infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen Arm | Active comparator | Other: AcetaminophenAcetaminophen Suspension 160 mg / 5 mL: Oral dose immediately following IIV and every 4-6 hours up to 24 hours (Maximum 5 oral doses) |
| Placebo Arm | Placebo comparator | Other: PlaceboPlacebo Suspension: Oral dose immediately following IIV and every 4-6 hours up to 24 hours (Maximum 5 oral doses) |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The child must be 12 through 35 months of age.
- The child must only need a single dose of IIV during the current season. (Children only need 1 dose of vaccine in 2013-14 if they received a total of 2 or more doses of seasonal vaccine since July 1, 2010. Children who did not receive a total of 2 or more doses of seasonal vaccine since July 1, 2010 require 2 doses in 2013-14).[19]
- The parent/guardian must be willing and capable of providing written informed consent for the child.
- The parent/guardian must be available for follow-up and must at minimum have telephone access.
- The parent/guardian must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed).
Key exclusion criteria (17 listed)
- History of receipt of current year's licensed influenza vaccine.
- History of a severe allergic reaction (e.g. anaphylaxis) to any component of influenza vaccine, including egg protein, formaldehyde, octylphenol ethoxylate, gelatin, or thimerosal if using thimerosal containing vaccine.
- History of a severe allergic reaction (e.g. anaphylaxis) following a prior dose of influenza vaccine.
- History of an allergic reaction following acetaminophen or ingredients in the acetaminophen product.
- History of an allergic reaction following ibuprofen or ingredients in the ibuprofen product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen | Other | Acetaminophen Arm |
| Placebo | Other | Placebo Arm |
Primary outcome
Completion of study procedures
Time frame: 1 month
Percent of participants for whom study procedures were completed successfully (prophylactic medication administered, temperature measured, memory aid completed, venipunctures performed)
1 secondary outcome
Immune Response to IIV
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
Related trials for Fever
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
Active, not recruitingPhase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Marburg Virus Disease
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruitingPhase 2
Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
Typhoid Carrier, Typhoid Fever
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel B Walter, MD principal investigator
Duke University
Karen Broder, MD principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen in people with Fever, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of study procedures (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.