Phase 3 N=374 Randomized Triple-blind Prevention

Acetaminophen Before Vaccines for Infants Study (AVIS)

Fever

Bottom Line

View on ClinicalTrials.gov: NCT00325819 ↗

Enrolled (actual)

374

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: Fever >=38C Within 32 Hours of Vaccination. — 14; 22 percentage of participants — p=0.053

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Acetaminophen (Drug); placebo (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Fever >=38C Within 32 Hours of Vaccination.	14; 22	0.053
SECONDARY Fever >=39C Within 32 Hours of Vaccination.	0; 2	0.08
SECONDARY Study Assignment Unblinded	3; 9	0.02 sig
SECONDARY Medical Utilization	3; 6	0.14
SECONDARY Infant Fussiness	42; 38; 58; 62; 10; 24	0.001 sig
SECONDARY Parent Time Lost From Sleep	73; 77; 27; 23; 3; 5	0.40
SECONDARY Infant Time Lost From Sleep	78; 81; 22; 19; 2; 2	1.00
SECONDARY Parent Time Lost From Work	4; 1	0.18

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.

Eligibility Criteria

Inclusion Criteria

Child is a current Group Health enrollee.
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

If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00325819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.