Is the immune response to influenza vaccination in obese children the same as in normal weight childre
Phase 1
- Conditions
- Relationship between obesity and immune responsesTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2018-004386-14-IS
- Lead Sponsor
- andspitali University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Study group: BMI > 30
Control group: BMI < 25
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Failure to supply informed consent
Immune suppression, allergy to vaccine components or any other contraindication to receiving the vaccines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study immune responses to influenza vaccine in obese children in comparison to normal weight children.;Secondary Objective: To ascertain if any particular aspects of obesity, i.e. waist circumference, fat percentage or BMI as continious variables or sex, age and ethnicity as categorical variables are associated with differences in vaccine responses.;Primary end point(s): GMT titres to influenza vaccine.<br>Fourfold increase in titre post-vaccination compared with pre-vaccination;Timepoint(s) of evaluation of this end point: Bloods are drawn at the time of vaccination (pre-vaccination status) and repeated 4 weeks after vaccination (post-vaccination).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Multivariable modelling of risk factors for differences in immune responses;Timepoint(s) of evaluation of this end point: 4 weeks post immunisation