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
  Purpose

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.


Condition Intervention Phase
Fever
Drug: Acetaminophen
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 374
Study Start Date: May 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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

Ages Eligible for Study:   6 Weeks to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325819

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Lisa A Jackson, MD, MPH Group Health Cooperative
  More Information

Publications:
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00325819     History of Changes
Other Study ID Numbers: CDC Protocol #4665
Study First Received: May 11, 2006
Results First Received: July 17, 2013
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Acetaminophen
Vaccination
Immunization

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 28, 2014