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AVIS - Acetaminophen Before Vaccines for Infants Study

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00325819
First received: May 11, 2006
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  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 or placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Fever
U.S. FDA Resources

Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • To determine the efficacy of acetaminophen prophylaxis for prevention of post-vaccination fever (temperature 38ºC) following routine childhood immunizations. [ Time Frame: Fever within 32 hours following vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: On the day of or the day following vaccination. ] [ Designated as safety issue: No ]

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

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
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
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Lisa A Jackson, MD, MPH Group Health Cooperative
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
Last Updated: September 11, 2012
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
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013