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

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.

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Key information

Conditions

Influenza Virus Vaccine Adverse Reaction Infections Influenza Vaccine Allergy Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenza vaccination

Biological

Influenza vaccination "Influsplit Tetra" 2016/2017, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, batch: AFLBA 152AB.

Primary outcomes

Immune response

Time frame: 26 weeks

Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.
Rate of side effects

Time frame: 2 weeks

All participants documented side effects and training restrictions.

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Collaborators

Federal Institute of Sport Science

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2018
First posted: Aug 31, 2018
Registry last updated: Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed