Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUGSingle 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.
DRUGDouble 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.
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Elderly: Inclusion Criteria: * Age ≥65 year old. * Able to give informed consent. * Necessity to receive influenza seasonal vaccination in 2013-2015. * Availability for the duration of the study and willingness to attend all scheduled visits. * Hemoglobin value ≥100 g/l , Leukocytes ≥3.5 G/L, Platelets count ≥100 G/l at the time of screening, or determined within 8 weeks before screening in the course of regular medical examination and validated by the medical doctor. Solid-organ transplant recipients Inclusion criteria Age ≥18 year old Solid organ transplantation \>3 months before vaccination Stable patient followed at the outpatient clinic of the Transplantation Center Able to give informed consent. Necessity to receive influenza seasonal vaccination. Availability for the duration of the study and willingness to attend all scheduled visits.
Exclusion criteria
Previous life-threatening reaction to influenza vaccine (i.e. Guillain-Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Immunogenicity | weeks 2, 4 and 24 after vaccination | Humoral immune responses (antibodies directed against all three strains A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events as a Measure of Safety and Tolerability | 24 weeks after vaccination | To evaluate safety and tolerability of the influenza vaccine (split virion, inactivated), MUTAGRIP®, administered in single or double dose. |
Countries
Switzerland
Outcome results
None listed