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Clinical Immunization Safety Assessment (CISA) Project: Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After IIV

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01946594
First received: September 17, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Fever
Drug: Acetaminophen
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Completion of study procedures [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Percent of participants for whom study procedures were completed successfully (prophylactic medication administered, temperature measured, memory aid completed, venipunctures performed)


Secondary Outcome Measures:
  • Immune Response to IIV [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Immune responses (hemagglutination inhibition assay) to IIV in each group (proportion of subjects demonstrating seroprotection and seroconversion and geometric mean titer)


Other Outcome Measures:
  • IIV reactogenicity and use of medical care services [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Proportion of subjects in each group with fever, fussiness, change in appetite or sleep patterns, and receipt of medical attention


Enrollment: 41
Study Start Date: October 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen Arm

Acetaminophen Suspension 160 mg / 5 mL:

Oral dose immediately following IIV and every 4-6 hours up to 24 hours (Maximum 5 oral doses)

Drug: Acetaminophen
Placebo Comparator: Placebo Arm

Placebo Suspension:

Oral dose immediately following IIV and every 4-6 hours up to 24 hours (Maximum 5 oral doses)

Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be eligible for inclusion in the study the following enrollment criteria must be met:

  1. The child must be 12 through 35 months of age.
  2. 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]
  3. The parent/guardian must be willing and capable of providing written informed consent for the child.
  4. The parent/guardian must be available for follow-up and must at minimum have telephone access.
  5. 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).

Exclusion Criteria:

Participants must not have any of the following:

  1. History of receipt of current year's licensed influenza vaccine.
  2. 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.
  3. History of a severe allergic reaction (e.g. anaphylaxis) following a prior dose of influenza vaccine.
  4. History of an allergic reaction following acetaminophen or ingredients in the acetaminophen product.
  5. History of an allergic reaction following ibuprofen or ingredients in the ibuprofen product.
  6. History of liver disease.
  7. Currently taking the blood thinning drug warfarin (Coumadin).
  8. 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.
  9. 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.
  10. 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).
  11. 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).
  12. 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).
  13. Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
  14. 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).
  15. History of Guillain-Barré syndrome within 6 weeks of a prior dose of influenza vaccine.
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946594

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Emmanuel B Walter, MD Duke University School of Medicine
Principal Investigator: Karen Broder, MD Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01946594     History of Changes
Other Study ID Numbers: Pro00048541, 200-2012-53663
Study First Received: September 17, 2013
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
fever
antipyretics
acetaminophen
influenza vaccine
influenza, human
body temperature changes
Orthomyxoviridae Infections
RNA virus infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Antipyretics
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014