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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Fever
- Sponsor
- Duke University
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Completion of study procedures
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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,
- •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).
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Immune Response to IIV(1 month)