Acetaminophen Before Vaccines for Infants Study (AVIS)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/15/2017 |
| Start Date: | May 2006 |
| End Date: | September 2009 |
A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants
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.
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.
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.
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.
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