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

Phase 4

Completed

• Conditions: Influenza Vaccine Allergy; Influenza Virus Vaccine Adverse Reaction
• Interventions: Biological: Influenza Vaccination

• Registration Number: NCT03654937
• Lead Sponsor: Universität des Saarlandes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2016-12-31
• Study Completion: 2018-04-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
26h	Influenza Vaccination	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.
2h	Influenza Vaccination	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.

Primary Outcome Measures

Name	Time	Method
Immune response	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	2 weeks	All participants documented side effects and training restrictions.