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Completed

NCT Number: NCT00325819

Acetaminophen Before Vaccines for Infants Study (AVIS)

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 week–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Group Health Research Institute

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetaminophen

Drug

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

Placebo

Other

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

Primary outcomes

  1. Fever >=38C Within 32 Hours of Vaccination.

    Time frame: Fever within 32 hours following vaccination

    Fever, defined as rectal temperature >=38C within 32 hours of vaccination.

Secondary outcomes

  1. Fever >=39C Within 32 Hours of Vaccination.

    Time frame: Fever within 32 hours following vaccination

    Fever, defined as rectal temperature >=39C within 32 hours of vaccination.

  2. Study Assignment Unblinded

    Time frame: At any time during participation in the study

    The need for unblinding at any time during the study

  3. Medical Utilization

    Time frame: Within 32 hours of vaccination.

    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.

  4. Infant Fussiness

    Time frame: Within 32 hours of vaccination

    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.

  5. Parent Time Lost From Sleep

    Time frame: On the night following vaccinations

    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.

  6. Infant Time Lost From Sleep

    Time frame: On the night following vaccinations

    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.

  7. Parent Time Lost From Work

    Time frame: Through the day after vaccination

    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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 15, 2006
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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