NCT00325819

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

April 7, 2014

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

May 11, 2006

Results QC Date

July 17, 2013

Last Update Submit

October 11, 2017

Conditions

Fever

Keywords

AcetaminophenVaccinationImmunization

Outcome Measures

Primary Outcomes (1)

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

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

    Fever within 32 hours following vaccination

Secondary Outcomes (7)

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

    Fever within 32 hours following vaccination

  • Study Assignment Unblinded

    At any time during participation in the study

  • Medical Utilization

    Within 32 hours of vaccination.

  • Infant Fussiness

    Within 32 hours of vaccination

  • Parent Time Lost From Sleep

    On the night following vaccinations

  • +2 more secondary outcomes

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

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

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

AcetaminophenDRUG

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

Acetaminophen
placeboOTHER

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

Placebo

Eligibility Criteria

Age6 Weeks - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • 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.

    PMID: 21698100RESULT

MeSH Terms

Conditions

Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Lisa Jackson, MD, MPH
Organization
Group Health Research Institute
jackson.L@ghc.org
206-442-5216

Study Officials

  • Lisa A Jackson, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 15, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 13, 2017

Results First Posted

April 7, 2014

Record last verified: 2017-10

Locations

US(1)