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

NCT03654937 | Completed Phase 4

• 1 other identifier: Impftrain
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza Virus Vaccine Adverse Reaction; Influenza Vaccine Allergy

Keywords

Influenza vaccination; elite athletes; Immune response; Side effects

Outcome Measures

Primary Outcomes (2)

• Immune response

  Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.

  26 weeks

• Rate of side effects

  All participants documented side effects and training restrictions.

  2 weeks

Study Arms (2)

2h

ACTIVE COMPARATOR

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.

Biological: Influenza Vaccination

26h

ACTIVE COMPARATOR

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.

Biological: Influenza Vaccination

Interventions

Influenza Vaccination BIOLOGICAL

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

26h; 2h

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• performance-oriented training on at least five days a week, healthy athletes

You may not qualify if:

• current acute infection, allergy to the vaccine, immunosuppression, pregnancy, rheumatic diseases

Sponsors & Collaborators

• Universität des Saarlandes: lead
• Federal Institute of Sport Science: collaborator

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: September 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: April 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08