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

Influenza Vaccine Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654937
• Other study ID #: Impftrain
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: August 2018
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 1, 2018
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza Vaccine Allergy
• Influenza Virus Vaccine Adverse Reaction
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Saarland University	German Federal Institute of Sport Science

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of side effects	All participants documented side effects and training restrictions.	2 weeks