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

NCT ID: NCT03654937

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-04-01

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.

Detailed Description

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Conditions

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Influenza Virus Vaccine Adverse Reaction Influenza Vaccine Allergy

Keywords

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Influenza vaccination elite athletes Immune response Side effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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2h

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.

Group Type ACTIVE_COMPARATOR

Influenza Vaccination

Intervention Type BIOLOGICAL

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

26h

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.

Group Type ACTIVE_COMPARATOR

Influenza Vaccination

Intervention Type BIOLOGICAL

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

Interventions

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Influenza Vaccination

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

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal Institute of Sport Science

OTHER

Sponsor Role collaborator

Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Impftrain

Identifier Type: -

Identifier Source: org_study_id