A prospective pilot study investigating the impact of obesity on seroprotection after influenza vaccination in children aged 9-17 years.

Women's and Children's Hospital0 sites44 target enrollmentJuly 26, 2017

Overview

No summary available.

Registry

who.int

Start Date

July 26, 2017

End Date

August 23, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Women's and Children's Hospital

•All participants must satisfy ALL the following criteria at study entry:
•1\. Participants are healthy children aged between 9\-17 years at the time of enrolment.
•2\. Participants who, in the opinion of the study staff, can and will comply with the requirements of the protocol (eg return for follow\-up visits, blood collection).
•3\. Participants who can provide assent and have a parent willing to provide consent.
•Additional criteria specific to cases and controls include:
•Cases \- Obese children (BMI \>\=95th percentile for age and gender) aged 9\-17 years. Total number to be enrolled is 25 cases.
•Controls \- Non\-obese children (BMI 5th \- \<95th percentile for age and gender) aged 9\-17 years. Total number to be enrolled is 25 controls.

•Presence of any of the following criteria will exclude the subject from receipt of influenza vaccination as part of the study:
•1\. History of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes mellitus requiring treatment with insulin).
•2\. Any syndromal and/or endocrinological causes for obesity.
•3\. History of seasonal influenza vaccination within the last six months prior to enrolment.
•4\. History of any immunosuppressive condition (eg HIV infection) or on immunosuppressing medication.
•5\. Any contraindication to influenza immunisation according to the Australian Immunisation Handbook.
•6\. Anaphylaxis following a previous dose of any influenza vaccine
•7\. Anaphylaxis following any vaccine component.
•8\. History of egg allergy.
•9\. History of Guillain Barre syndrome.