FeverNCT02212990
The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine
A study testing Acetaminophen Arm and Ibuprofen Arm in people with Fever, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- Acetaminophen Arm and Ibuprofen Arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2016
- Phase
- Interventional
- 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 6 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be 6 through 47 months of age.
- The child must weigh 5.4 kilograms.
- The child must be receiving IIV this season.
- If the child is two years of age or older and needs two doses of influenza vaccine this season the parent/guardian intends for the child to receive IIV for the second dose.
- 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
- History of receipt of current year's licensed influenza vaccine.
- Planned receipt of the live attenuated nasally administered influenza vaccine this year
- 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.
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- History of an allergic reaction following aspirin or other pain reliever or fever reducer.
- History of liver disease.
- Currently taking the blood thinning drug warfarin (Coumadin) or other blood thinners.
- History of recent or planned heart surgery within the past 3 months or next 3 months.
- History of stomach ulcer or bleeding problem.
- Currently already routinely taking prescription or nonprescription non-steroidal anti-inflammatory drugs or NSAIDs (aspirin, ibuprofen, naproxen, or others)
- 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 influenza 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 the last influenza vaccination in this study.
- 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. For those needing a second dose of IIV, 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 second dose of IIV 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 any dose of 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: Clinical Immunization Safety Assessment (CISA): A Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine (IIV) Administered to Children 6 Through 47 Months of Age
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.
- Conditions
- Fever
- Being tested
- Acetaminophen Arm, Placebo Arm, Ibuprofen Arm
- Keywords
- Fever, Antipyretics, Acetaminophen, Ibuprofen, Influenza vaccine, Influenza, Body temperature changes, Signs and symptoms
- Medical subject headings
- Fever, Influenza, Human, Body Temperature Changes, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen ArmOther
Blinded Therapy
Placebo ArmOther
Blinded Therapy
Ibuprofen ArmOther
Open Label Therapy
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen Arm | Active comparator | Acetaminophen Suspension 160mg / 5mL Oral dose immediately following IIV and every 4 to 6 hours up to 24 hours (Maximum 5 oral doses) Receives: Other: Acetaminophen Arm |
| Placebo Arm | Placebo comparator | Placebo Suspension Oral dose immediately following IIV and every 4 to 6 hours up to 24 hours (Maximum 5 oral doses) Receives: Other: Placebo Arm |
| Ibuprofen Arm | Active comparator | Ibuprofen Suspension 100mg / 5mL Oral dose immediately following IIV and every 6 to 8 hours up to 24 hours (Maximum 4 oral doses) Receives: Other: Ibuprofen Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month following the last dose of IIV
Secondary outcomes (2)
Seroprotection
Seroprotection (the proportion of subjects with an HAI titer >1:40) to each IIV antigen
Measured: One month following the last dose of IIV
Geometric mean HAI titer
Geometric mean HAI titer (GMT) and 95% confidence interval for each IIV antigen
Measured: One month following the last dose of IIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 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, MPH, Principal investigator, Duke Unviersity School of MedicineKaren Broder, MD, Principal investigator, Centers for Diseaes Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212990
- Sponsor's protocol ID
- Pro00056213
- Other IDs
- 200-2012-53663
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2014
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Immunization Safety Assessment (CISA): A Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine (IIV) Administered to Children 6 Through 47 Months of Age
- ClinicalTrials.gov ID
- NCT02212990
- Acronym / sponsor ID
- Pro00056213
- Conditions
- Fever
- Keywords
- Fever, Antipyretics, Acetaminophen, Ibuprofen, Influenza vaccine, Influenza, Body temperature changes, Signs and symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Aug 2014 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen Arm | Active comparator | Other: Acetaminophen ArmAcetaminophen Suspension 160mg / 5mL Oral dose immediately following IIV and every 4 to 6 hours up to 24 hours (Maximum 5 oral doses) |
| Placebo Arm | Placebo comparator | Other: Placebo ArmPlacebo Suspension Oral dose immediately following IIV and every 4 to 6 hours up to 24 hours (Maximum 5 oral doses) |
| Ibuprofen Arm | Active comparator | Other: Ibuprofen ArmIbuprofen Suspension 100mg / 5mL Oral dose immediately following IIV and every 6 to 8 hours up to 24 hours (Maximum 4 oral doses) |
Who may qualify
- Ages
- 6 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The child must be 6 through 47 months of age.
- The child must weigh 5.4 kilograms.
- The child must be receiving IIV this season.
- If the child is two years of age or older and needs two doses of influenza vaccine this season the parent/guardian intends for the child to receive IIV for the second dose.
- The parent/guardian must be willing and capable of providing written informed consent for the child.
Key exclusion criteria (21 listed)
- History of receipt of current year's licensed influenza vaccine.
- Planned receipt of the live attenuated nasally administered influenza vaccine this year
- 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.
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 ArmBlinded Therapy | Other | Acetaminophen Arm |
| Placebo ArmBlinded Therapy | Other | Placebo Arm |
| Ibuprofen ArmOpen Label Therapy | Other | Ibuprofen Arm |
Primary outcome
Seroconversion
Time frame: One month following the last dose of IIV
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
2 secondary outcomes
Seroprotection
Time frame: One month following the last dose of IIV
Geometric mean HAI titer
Time frame: One month following the last dose of IIV
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 7 Feb 2018.
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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, MPH principal investigator
Duke Unviersity School of Medicine
Karen Broder, MD principal investigator
Centers for Diseaes 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 study testing Acetaminophen Arm and Ibuprofen Arm 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 7 inclusion and 21 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 7 Feb 2018. 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.
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?
Seroconversion (time frame: One month following the last dose of IIV). 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 7 Feb 2018.