NCT02746783

Immunogenicity and Safety of the Seasonal Flu Vaccine in Elderly and in SOT Recipients

Immunogenicity (Humoral and Cellular Immune Responses) and Safety of the Seasonal Flu Vaccine in Elderly and in SOT Recipients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the effect of a different dose of the seasonal flu vaccine 2013-2015 on the immune response to improve the investigators understanding of cellular and humoral immune responses induced. The scope of this study is to determine the profile of cellular activation and antibody production in the ageing immune system following flu immunization. This study will enroll 100 male or female subjects ≥65 year old and 90 transplant recipients. These persons will be deemed to be " at risk " in case of influenza infection and should be vaccinated according to Swiss Federal Office of Public Health. A medical doctor from the CHUV will inform the patients about the present study and ask them whether they would be willing to participate in the study. All subjects will be distributed between the two groups according to a computer-generated randomization sequence. The randomization will be done in blocks to ensure balance across groups. The participants and site staff will not be blinded due to the different administration assignments. Group 1 subjects will receive a single dose and group 2 subjects a double dose of MUTAGRIP® manufactured by Sanofi Pasteur containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. Vaccine immunogenicity and safety will be assessed 1, 2, 4 and 24 weeks after vaccination. Study duration per volunteer is 6 months after vaccination.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Single dose MUTAGRIP® influenza vaccine	All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time.
DRUG	Double dose of MUTAGRIP® influenza vaccine	All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2016-04-21
• Last updated: 2020-03-26

Locations

1 site across 1 country: Switzerland