NCT00325819

Acetaminophen Before Vaccines for Infants Study (AVIS)

A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 6 Weeks – 9 Months
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Fever

Interventions

Type	Name	Description
DRUG	Acetaminophen	Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
OTHER	placebo	Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-05-15
• Last updated: 2017-10-13
• Results posted: 2014-04-07

Locations

1 site across 1 country: United States