Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325819
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2006-05-11
Brief Title:
Acetaminophen Before Vaccines for Infants Study AVIS
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None