Acetaminophen Before Vaccines for Infants Study (AVIS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00325819
First received: May 11, 2006
Last updated: February 25, 2014
Last verified: February 2014

May 11, 2006
February 25, 2014
May 2006
September 2009   (final data collection date for primary outcome measure)
Fever >=38C Within 32 Hours of Vaccination. [ Time Frame: Fever within 32 hours following vaccination ] [ Designated as safety issue: No ]
Fever, defined as rectal temperature >=38C within 32 hours of vaccination.
To determine the efficacy of acetaminophen prophylaxis for prevention of post-vaccination fever (temperature 38ºC) following routine childhood immunizations.
Complete list of historical versions of study NCT00325819 on ClinicalTrials.gov Archive Site
  • Fever >=39C Within 32 Hours of Vaccination. [ Time Frame: Fever within 32 hours following vaccination ] [ Designated as safety issue: No ]
    Fever, defined as rectal temperature >=39C within 32 hours of vaccination.
  • Study Assignment Unblinded [ Time Frame: At any time during participation in the study ] [ Designated as safety issue: No ]
    The need for unblinding at any time during the study
  • Medical Utilization [ Time Frame: Within 32 hours of vaccination. ] [ Designated as safety issue: No ]
    Telephone calls to the consulting nurse or the child's physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination.
  • Infant Fussiness [ Time Frame: Within 32 hours of vaccination ] [ Designated as safety issue: No ]
    Parents were asked to record level of fussiness (compared with the child's usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual.
  • Parent Time Lost From Sleep [ Time Frame: On the night following vaccinations ] [ Designated as safety issue: No ]
    Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.
  • Infant Time Lost From Sleep [ Time Frame: On the night following vaccinations ] [ Designated as safety issue: No ]
    Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.
  • Parent Time Lost From Work [ Time Frame: Through the day after vaccination ] [ Designated as safety issue: No ]
    Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days.
To determine whether use of prophylactic acetaminophen reduces the infant’s medical utilization, parents’ time lost from work, and sleep lost by parents and infant within a day of vaccination.
Not Provided
Not Provided
 
Acetaminophen Before Vaccines for Infants Study (AVIS)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Fever
  • Drug: Acetaminophen
    Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
    Other Name: Acetaminophen
  • Other: placebo
    Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
    Other Name: placebo
  • Active Comparator: Acetaminophen
    Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
    Intervention: Drug: Acetaminophen
  • Placebo Comparator: Placebo
    Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
    Intervention: Other: placebo
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. Epub 2011 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 9 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00325819
CDC Protocol #4665
Yes
Group Health Cooperative
Group Health Cooperative
Centers for Disease Control and Prevention
Principal Investigator: Lisa A Jackson, MD, MPH Group Health Cooperative
Group Health Cooperative
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP