Prevention of influenza infection in adults from 60 years of age and older MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: quadrivalent influenza vaccine
Product Code: 522
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
O
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Sixty years of age and older on the day of inclusion - Able to attend all scheduled visits and to comply with all trial procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 770 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 770
Exclusion criteria
Exclusion criteria: - Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile - Participation at the time of study enrollment (or in the 4 weeks [28 days] preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure - Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to V02 - Previous vaccination against influenza (in the previous 6 months) with either the trial vaccine or another vaccine - Receipt of immune globulins, blood or blood-derived products in the past 3 months - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances - Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) vaccination based on Investigator’s judgement - Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the trial conduct or completion - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion - Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature = 38.0°C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study - Personal or family history of Guillain Barré syndrome (GBS) - Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for = 5 years)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that QIV-HD induces an immune response that is superior to the responses induced by QIV-SD for all 4 virus strains 28 days post-vaccination in subjects 60 to 64 years of age and in subjects 65 years of age and older.;Secondary Objective: To further describe the immune response induced by QIV-HD and QIV-SD in all subjects by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). To describe the safety profile of all subjects by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).;Primary end point(s): Geometric Mean Titers (GMTs) of influenza vaccine antibodies (post-vaccination) : Antibody titers will be measured by hemagglutination inhibition (HAI) assay;Timepoint(s) of evaluation of this end point: Day 28 (post-vaccination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Geometric Mean Titers (GMTs) of influenza vaccine antibodies (pre- and post-vaccination) : Antibody titers will be measured by HAI assay - Geometric Mean Titers Ratio (GMTR) of influenza vaccine antibodies (post-/pre-vaccination) : Antibody titers will be measured by HAI assay - Percentage of participants with antibody titers = 40 [1/dil] : Antibody titers will be measured by HAI assay - Percentage of participants achieving serconversion : Influenza vaccine antigens will be measured by HAI assay Seroconversion is defined as either a pre-vaccination titer lower than (<) 10 [1/dil] and a post-vaccination titer greater than or equal to (=) 40 [1/dil], or a pre-vaccination titer = 10 [1/dil] and a = 4-fold increase in post-vaccination titer - Percentage of participants reporting solicited injection site reactions and systemic reactions : Injection site reactions: pain, erythema, swelling, induration and ecchymosis Systemic reactions: fever, headache, malaise, myalgia and shivering;Timepoint(s) of evaluation of this end point: - Geometric Mean Titers (GMTs) of influenza vaccine antibodies (pre- and post-vaccination) : Day 0 (pre-vaccination) and Day 28( post-vaccination) - Geometric Mean Titers Ratio (GMTR) of influenza vaccine antibodies (post-/pre-vaccination) : Day 0 (pre-vaccination) and Day 28 (post-vaccination) - Percentage of participants with antibody titers = 40 [1/dil] : Day 28 (post-vaccination) - Percentage of participants achieving serconversion : Day 28 (post-vaccination) - Percentage of participants reporting solicited injection site reactions and systemic reactions : Within 7 days post-vaccination | — |
Countries
France, Germany, Netherlands
Contacts
Public ContactStéphanie Pepin
Sanofi Pasteur
Outcome results
None listed