Phase 3
Completed N=374
Acetaminophen Before Vaccines for Infants Study (AVIS)
Source: ClinicalTrials.gov NCT00325819 ↗Enrolled (actual)
374
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Fever >=38C Within 32 Hours of Vaccination. — 14; 22 percentage of participants — p=0.053
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.
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 |
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.
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. Informational only — not medical advice.