Viewing Study NCT00158665



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Study NCT ID: NCT00158665
Status: COMPLETED
Last Update Posted: 2017-10-13
First Post: 2005-09-08

Brief Title: A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age
Sponsor: Kaiser Permanente
Organization: Kaiser Permanente

Study Overview

Official Title: A Comparison of One Versus Two Doses of Influenza Vaccine in Children Aged 5-8 Years of Age Receiving Influenza Vaccine for the First Time
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 the study was to find out if children 5 through 8 years of age who are getting influenza vaccine for the first time should get one or two doses
Detailed Description: Currently two doses of influenza vaccine are recommended for children younger than 9 years receiving influenza vaccine for the first time While the scientific support for 2 doses of vaccine in infants and toddlers is sound the need for 2 doses of vaccine for adequate immunogenicity in older children is less certain If the immunogenicity of a one-dose vaccine regimen is comparable to a two-dose regimen then one dose would be preferable for reasons of safety practicality and economics and would reduce a major barrier to vaccination in this injection-adverse age group This study compared the immunogenicity and reactogenicity of one versus two doses of influenza vaccine in children aged 5 to 8 years old receiving influenza vaccine for the first time All children enrolled in the study received two doses of vaccine and the immune response after one dose of vaccine was compared to the immune response after two doses of vaccine

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
Secondary IDs
Secondary ID Type Domain Link
VSD contract 200-2002-00732 OTHER_GRANT Centers for Disease Control and Prevention None