Acetaminophen Before Vaccines for Infants Study (AVIS)
Information source: Group Health Cooperative
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever
Intervention: Acetaminophen (Drug); placebo (Other)
Phase: Phase 3
Sponsored by: Group Health Cooperative
Official(s) and/or principal investigator(s):
Lisa A Jackson, MD, MPH, Principal Investigator, Affiliation: Group Health Cooperative
The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol)
for routine infant vaccinations is helpful in preventing fever or other symptoms.
Official title: A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Fever >=38C Within 32 Hours of Vaccination.
Fever >=39C Within 32 Hours of Vaccination.
Study Assignment Unblinded
Parent Time Lost From Sleep
Infant Time Lost From Sleep
Parent Time Lost From Work
Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended
childhood vaccinations. Although serious events are rare, post-vaccination fever causes
discomfort for the child, can lead to medical utilization, can rarely result in febrile
seizure, and can cause a working parent to miss time from their job to care for a febrile
infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants
receiving current vaccinations, in terms of reduction of discomfort for the child,
improvement of quality-of-life indicators for the parent, or reduction of medical
utilization, have not been measured. This randomized, blinded, placebo-controlled trial will
assess the efficacy of prophylaxis with acetaminophen in prevention of fever following
routine childhood immunizations.
Minimum age: 6 Weeks.
Maximum age: 9 Months.
1. Child is a current Group Health enrollee.
2. Child will be seen at a Group Health clinic for a Well Child visit that is expected
to include 2 or more vaccines after 6 wks and before 10 months of age.
1. If child was born at less than 36 weeks of gestation, the child is not eligible until
4 months of age or older.
2. If the child's birth weight was less than 5. 5 pounds (2500 grams), the child is not
eligible until 4 months of age or older.
Locations and Contacts
Group Health Research Institute, Seattle, Washington 98101, United States
Starting date: May 2006
Last updated: February 25, 2014