Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes

Study Overview
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Brief Summary
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Seasonal influenza vaccination was used to assess whether induction of immunity as well as the rate of side effects is influenced by the timing of the last training session before vaccination. Healthy athletes were vaccinated with the tetravalent influenza vaccine and blood samples were collected before, 1, 2 and 26 weeks after vaccination. The athletes were randomly assigned to vaccination within 2 hours after the last training session (2h) vs. vaccination after a resting period of at least 26 hours (26h). All participants documented side effects and training restrictions. Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.

Official Title
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Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes

Conditions
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Influenza Virus Vaccine Adverse Reaction, Influenza Vaccine Allergy

Intervention / Treatment
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* Biological: Influenza Vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: performance-oriented training on at least five days a week, healthy athletes Exclusion Criteria: current acute infection, allergy to the vaccine, immunosuppression, pregnancy, rheumatic diseases

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2h<br>The participants were asked to report for their vaccination immediately after an intensive bout of training (not later than two hours after). The influenza vaccine was administered via intra-muscular injection into the deltoid muscle of the non-dominant arm in a standardized manner. | Biological: Influenza Vaccination<br>* Influenza vaccination Influsplit Tetra 2016/2017, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, batch: AFLBA 152AB.<br>|
| Active Comparator: 26h<br>The athletes of the second group were vaccinated after an entire day (between 24 and 26 hours) after their last training session.The vaccine was administered via intra-muscular injection into the deltoid muscle of the non-dominant arm in a standardized manner. | Biological: Influenza Vaccination<br>* Influenza vaccination Influsplit Tetra 2016/2017, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, batch: AFLBA 152AB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response | Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay. | 26 weeks | 
| Rate of side effects | All participants documented side effects and training restrictions. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elite athletes, Influenza vaccination, Immune response, Side effects