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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03654937
Enrollment
45
Registered
2018-08-31
Start date
2016-09-01
Completion date
2018-04-01
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Vaccine Allergy, Influenza Virus Vaccine Adverse Reaction

Keywords

Influenza vaccination, elite athletes, Immune response, Side effects

Brief summary

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.

Interventions

BIOLOGICALInfluenza Vaccination

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

Sponsors

Federal Institute of Sport Science
CollaboratorOTHER
Universität des Saarlandes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Immune response26 weeksInfluenza-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 effects2 weeksAll participants documented side effects and training restrictions.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026