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Acetaminophen Before Vaccines for Infants Study (AVIS)

NCT ID: NCT00325819

Last Updated: 2017-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fever

Keywords

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Acetaminophen Vaccination Immunization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Acetaminophen

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

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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Acetaminophen

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

Intervention Type DRUG

placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa A Jackson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants. PLoS One. 2011;6(6):e20102. doi: 10.1371/journal.pone.0020102. Epub 2011 Jun 17.

Reference Type RESULT
PMID: 21698100 (View on PubMed)

Other Identifiers

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CDC Protocol #4665

Identifier Type: -

Identifier Source: org_study_id