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Clinical Trials/NCT03654937
NCT03654937
Completed
Phase 4

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

Universität des Saarlandes0 sites45 target enrollmentSeptember 1, 2016

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Influenza Virus Vaccine Adverse Reaction
Sponsor
Universität des Saarlandes
Enrollment
45
Primary Endpoint
Immune response
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
April 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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.

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