Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
August 30, 2018 updated by: Universität des Saarlandes
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 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.
|
Influenza vaccination "Influsplit Tetra" 2016/2017, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, batch: AFLBA 152AB.
|
|
ACTIVE_COMPARATOR: 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.
|
Influenza vaccination "Influsplit Tetra" 2016/2017, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, batch: AFLBA 152AB.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immune response
Time Frame: 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.
|
26 weeks
|
|
Rate of side effects
Time Frame: 2 weeks
|
All participants documented side effects and training restrictions.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2016
Primary Completion (ACTUAL)
December 31, 2016
Study Completion (ACTUAL)
April 1, 2018
Study Registration Dates
First Submitted
August 30, 2018
First Submitted That Met QC Criteria
August 30, 2018
First Posted (ACTUAL)
August 31, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Impftrain
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.