A Clinical Study of Pre and Post Vaccination Serology in Children Receiving the Seasonal Southern Hemisphere Formulation of Inactivated Influenza Vaccine

Not Applicable

• Conditions: Influenza; Infection - Other infectious diseases

• Registration Number: ACTRN12619000118101
• Lead Sponsor: Women's and Children's Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-25
• Last Update Posted: 4 February 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Be healthy males or females, aged between 6 months and 9 years at the time of providing informed consent.
•Plan to be vaccinated with the seasonal Southern Hemisphere formulation of the Inactivated Influenza vaccine
•Have a parent able and willing to provide written informed consent for themselves and child.
•Able to understand, and willing and physically able to comply with study procedures.
•Be able to provide a sample of up to 3mL of venous blood pre-vaccination without undue distress/discomfort.

Exclusion Criteria

•Child has received any licensed or investigational vaccine or receiving any investigational product in the 28 days prior to taking Visit 1 blood sample;
•Child has a confirmed or suspected immunosupporessive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder including human immunodeficiency virus (HIV) infection at the time of study enrolment;
•Child has undergone chemotherapy or radiotherapy in the last 6 months at the time of study enrolment.
•The child currently (or within the last 90 days prior to blood collection) taking immunosuppressive or immunodulative medication, including systemic corticosteroids. Use of topical, inhalant or intra-articular corticosteroids is permitted prior to the study and during the on study period.
•Child has received immunoglobulin and/or blood product in the 28 days prior to taking Visit 1 blood sample.
•Parental or child participation in a clinical study that may interfere with participation in this study
•Anything that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody titres following seasonal influenza vaccination using serum assays.<br><br>[Baseline and 21 days post vaccination];Proportion achieving seroprotective titres (where a correlate of protection exists) following seasonal influenza vaccination using serum assays.[baseline and 21 days post vaccination]

Secondary Outcome Measures

Name	Time	Method
il [Nil]