AVIS - Acetaminophen Before Vaccines for Infants Study - Full Text View

Sponsor:	Group Health Cooperative
Collaborator:	Centers for Disease Control and Prevention
Information provided by:	Group Health Cooperative
ClinicalTrials.gov Identifier:	NCT00325819

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment
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: Childhood Immunization Fever

Drug Information available for: Acetaminophen CT 2584

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.

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.

Estimated Enrollment:	1000
Study Start Date:	May 2006

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:

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.

Contacts and Locations

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

Contacts

Contact: Barbara A Carste, MPH

206-287-2466

carste.b@ghc.org

Locations

United States, Washington
Group Health Cooperative Center for Health Studies	Recruiting
Seattle, Washington, United States, 98101
Principal Investigator: Lisa A Jackson, MD, MPH

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

Study ID Numbers:	CDC Protocol #4665
Study First Received:	May 11, 2006
Last Updated:	May 11, 2006
ClinicalTrials.gov Identifier:	NCT00325819 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Group Health Cooperative:

Acetaminophen
Vaccination
Immunization

Additional relevant MeSH terms:

Fever
Signs and Symptoms
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Peripheral Nervous System Agents
Analgesics
Body Temperature Changes
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on November 30, 2009