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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

Status: Completed

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.

Clinical Details

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.

Secondary outcome:

Fever >=39C Within 32 Hours of Vaccination.

Study Assignment Unblinded

Medical Utilization

Infant Fussiness

Parent Time Lost From Sleep

Infant Time Lost From Sleep

Parent Time Lost From Work

Detailed description: 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. Gender(s): Both.


Inclusion Criteria: 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. Exclusion Criteria: 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
Additional Information

Starting date: May 2006
Last updated: February 25, 2014

Page last updated: August 23, 2015

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