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

NCT03654937 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-08-31

No results posted yet for this study

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.

Conditions

  • Influenza Virus Vaccine Adverse Reaction
  • Influenza Vaccine Allergy

Interventions

BIOLOGICAL

Influenza Vaccination

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

Sponsors & Collaborators

  • Federal Institute of Sport Science

    collaborator OTHER

  • Universität des Saarlandes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2016-12-31
Completion
2018-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654937 on ClinicalTrials.gov