Relationship between obesity and immune responses
Conditions
Interventions
Trade Name: Influvac
Product Name: Influvac
Product Code: FluVacc
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Sponsors
Landspitali University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study group: BMI > 30 Control group: BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Failure to supply informed consent Immune suppression, allergy to vaccine components or any other contraindication to receiving the vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Iceland
Contacts
Public ContactPrimary investigator
Landspitali University Hospital
Outcome results
None listed