Acetaminophen Before Vaccines for Infants Study (AVIS)

Kaiser Permanente

Status and phase: Completed; Phase 3

Conditions: Fever

Treatments: Drug: Acetaminophen; Other: placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00325819

CDC Protocol #4665

Details and patient eligibility

About

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.

Full 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.

Enrollment: 374 patients

Sex: All

Ages: 6 weeks to 9 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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374 participants in 2 patient groups, including a placebo group

Acetaminophen

Active Comparator group

Description:

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

Treatment:

Drug: Acetaminophen

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo