Back to resultsImmune Response and Risk of Side Effects After Influenza Vaccination in Athletes
Primary Purpose
Influenza Virus Vaccine Adverse Reaction, Influenza Vaccine Allergy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Influenza Vaccination
Sponsored by
About this trial
This is an interventional basic science trial for Influenza Virus Vaccine Adverse Reaction focused on measuring Influenza vaccination, elite athletes, Immune response, Side effects
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2h
26h
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Rate of side effects
All participants documented side effects and training restrictions.
Secondary Outcome Measures
Full Information
NCT ID
NCT03654937
First Posted
August 30, 2018
Last Updated
August 30, 2018
Sponsor
Universität des Saarlandes
Collaborators
Federal Institute of Sport Science
1. Study Identification
Unique Protocol Identification Number
NCT03654937
Brief Title
Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
Official Title
Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universität des Saarlandes
Collaborators
Federal Institute of Sport Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Virus Vaccine Adverse Reaction, Influenza Vaccine Allergy
Keywords
Influenza vaccination, elite athletes, Immune response, Side effects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2h
Arm Type
Active Comparator
Arm Description
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.
Arm Title
26h
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccination
Intervention Description
Influenza vaccination "Influsplit Tetra" 2016/2017, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, batch: AFLBA 152AB.
Primary Outcome Measure Information:
Title
Immune response
Description
Influenza-specific T-cells were quantified after stimulation with the vaccine based on intracellular cytokine staining. Antibodies were quantified by ELISA and neutralisation assay.
Time Frame
26 weeks
Title
Rate of side effects
Description
All participants documented side effects and training restrictions.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
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