AVIS - Acetaminophen Before Vaccines for Infants Study

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.

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.

• Active Comparator: Acetaminophen
  Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
  Intervention: Drug: Acetaminophen or placebo
• Active Comparator: Placebo
  Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
  Intervention: Drug: Acetaminophen or placebo

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.