CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 374 enrolled
Drug / intervention
Acetaminophen +1 moredrug
Likely dose
Acetaminophen 10-15 mg per kg, up to five dosesAI-extracted
Key inclusion· 2
  • ✓Child is enrolled in Group Health insurance.
  • ✓Scheduled for a Well Child visit at a Group Health clinic with ≥2 vaccines planned, between 6 weeks and 10 months of age.
Key exclusion· 2
  • ✕Birth at <36 weeks gestation unless child is now ≥4 months old.
  • ✕Birth weight <2500 grams unless child is now ≥4 months old.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00325819
NCT00325819Phase 3Completed
CompareCT.gov

A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants

Kaiser Permanente·interventional·Posted May 15, 2006·Updated Oct 13, 2017

In Brief

A Phase 3 clinical trial evaluating Acetaminophen and placebo for Fever. Completed, enrolled 374 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFever
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2006
Enrollment StartMay 1, 2006
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.1 years ago

Interventions

Acetaminophendrug

Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.

placeboother

Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.