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Acetaminophen Before Vaccines for Infants Study (AVIS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00325819
First received: May 11, 2006
Last updated: February 25, 2014
Last verified: February 2014
Results First Received: July 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Fever
Interventions: Drug: Acetaminophen
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment and enrollment took place between May 2006 and September 2009. Children potentially eligible for study participation were identified from the Group Health data systems and parents were mailed a letter providing information on the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events followed participant enrollment prior to group assignment.

Reporting Groups
  Description
Acetaminophen Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
Placebo Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.

Participant Flow:   Overall Study
    Acetaminophen     Placebo  
STARTED     185     189  
COMPLETED     176     176  
NOT COMPLETED     9     13  
Study product lost in mail                 2                 1  
Did not take a dose of study product                 4                 9  
Lost to Follow-up                 3                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who did not receive acetaminophen or placebo due to postal problems (3), who were not given a first dose of acetaminophen or placebo (13) or who were lost to follow-up due to study diary not being returned (6) were not included in analysis.

Reporting Groups
  Description
Acetaminophen Subjects who were randomized to receive acetaminophen
Placebo Subjects who were randomized to receive placebo
Total Total of all reporting groups

Baseline Measures
    Acetaminophen     Placebo     Total  
Number of Participants  
[units: participants]
  176     176     352  
Age  
[units: participants]
     
<=18 years     176     176     352  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Weeks]
Mean ± Standard Deviation
  24.8  ± 4.7     24.2  ± 4.7     24.5  ± 4.7  
Gender  
[units: participants]
     
Female     77     95     172  
Male     99     81     180  
Region of Enrollment  
[units: participants]
     
United States     176     176     352  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Fever >=38C Within 32 Hours of Vaccination.   [ Time Frame: Fever within 32 hours following vaccination ]

2.  Secondary:   Fever >=39C Within 32 Hours of Vaccination.   [ Time Frame: Fever within 32 hours following vaccination ]

3.  Secondary:   Study Assignment Unblinded   [ Time Frame: At any time during participation in the study ]

4.  Secondary:   Medical Utilization   [ Time Frame: Within 32 hours of vaccination. ]

5.  Secondary:   Infant Fussiness   [ Time Frame: Within 32 hours of vaccination ]

6.  Secondary:   Parent Time Lost From Sleep   [ Time Frame: On the night following vaccinations ]

7.  Secondary:   Infant Time Lost From Sleep   [ Time Frame: On the night following vaccinations ]

8.  Secondary:   Parent Time Lost From Work   [ Time Frame: Through the day after vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lisa Jackson, MD, MPH
Organization: Group Health Research Institute
phone: 206-442-5216
e-mail: jackson.L@ghc.org


Publications of Results:

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00325819     History of Changes
Other Study ID Numbers: CDC Protocol #4665
Study First Received: May 11, 2006
Results First Received: July 17, 2013
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board