A study on the influence of obesity on the protection after influenza vaccination in children aged 9-17 years.

Phase 4

Completed

• Conditions: Obesity in children and adolescents; Response to influenza vaccination; Inflammatory and Immune System - Normal development and function of the immune system; Diet and Nutrition - Obesity; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12617001086358
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-26
• Study Completion: 2021-08-23
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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.

Exclusion Criteria

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.
10. Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw.
11. Any major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study, or interfere with the evaluation of the study objectives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The count and proportion in the case and control groups with seroprotective Haemagglutination Inhibition Assay (HIA) titres (>=40) at 1 and 6 months post vaccination.[At baseline, 1 month and 6 months after influenza vaccination. <br><br><br><br>];Proportion in the case and control groups who achieve a four-fold rise in Haemagglutination Inhibition Assay (HIA) titres after influenza vaccination.<br>[Comparison of the baseline with the 1 month and 6 month post-vaccination results.]

Secondary Outcome Measures

Name	Time	Method
Geometric mean Haemagglutination Inhibition Assay titres in the case and control groups.<br>[Comparison of the baseline with the 1 month and 6 month post-vaccination results.];Mean geometric increase in Haemagglutination Inhibition Assay (HIA) titres in the case and control groups.[Comparison of the baseline with the 1 month and 6 month post-vaccination results.]