Clinical trial NCT00325819: Acetaminophen Before Vaccines for Infants Study (AVIS)
Official title: A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fever
Keywords: Acetaminophen
Vaccination
Immunization
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2006-05-15
Enrollment: 374
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fever >=38C Within 32 Hours of Vaccination.
timeFrame: Fever within 32 hours following vaccination
Secondary outcomes:
measure: Fever >=39C Within 32 Hours of Vaccination.
timeFrame: Fever within 32 hours following vaccination
measure: Study Assignment Unblinded
timeFrame: At any time during participation in the study
measure: Medical Utilization
timeFrame: Within 32 hours of vaccination.
measure: Infant Fussiness
timeFrame: Within 32 hours of vaccination
measure: Parent Time Lost From Sleep
timeFrame: On the night following vaccinations
measure: Infant Time Lost From Sleep
timeFrame: On the night following vaccinations
measure: Parent Time Lost From Work
timeFrame: Through the day after vaccination
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Lisa A Jackson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants. PLoS One. 2011;6(6):e20102. doi: 10.1371/journal.pone.0020102. Epub 2011 Jun 17.