Prophylaxis of influenza in subjects from 18 years of age MedDRA version: 14.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: 481
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactivated) A/H1N1-like strain
Concentration unit: µg/ml microgram(s)/millilitre
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged over 18 years on the day of inclusion 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 784 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 784
Exclusion criteria
Exclusion criteria: - Receipt of any vaccine in the 4 weeks preceding trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination - Previous vaccination against influenza with the 2011-2012 Northern Hemisphere vaccine, with either the trial vaccine or another vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of antibody responses induced by QIV compared with the licensed 2011-2012 TIV (containing the B/Brisbane strain) and the investigational TIV (containing the B/Florida strain) as assessed in all subjects by geometric mean titer (GMT) for each strain;Secondary Objective: Safety: 1) To describe the safety profile (injection site reactions, and systemic events) of each vaccine during the 21 days following vaccination, and SAEs, including AESIs, throughout the study in all adult and elderly subjects. Immunogenicity: 2) To evaluate the compliance, in terms of immunogenicity, of QIV with the requirements of the European Medicines Agency (EMA) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups 3) To demonstrate, in each age group, superiority of antibody response to the B/Brisbane strain in the QIV group compared to antibody response to the B/Brisbane strain in the TIV2 group 4) To demonstrate, in each age group, superiority of antibody response to the B/Florida strain in the QIV group compared to antibody response to the B/Florida strain in the TIV1 group ;Primary end point(s): For each group, anti-hemagglutinin (HA) antibody titers for the four strains, as applicable, 21 days (D21) after vaccination. GMTs will be used as the primary parameter;Timepoint(s) of evaluation of this end point: D21 after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: D21 after vaccination up to the end of the trial for follow up of SAEs;Secondary end point(s): Safety / Reactogenicity: • Occurrence of unsolicited systemic adverse event (AE) reported in the 30 minutes after injection • Occurrence of solicited (prelisted in the subject diary and electronic Case Report Form [CRF]) injection site reactions and systemic reactions within 7 days following injection • Occurrence of unsolicited (spontaneously reported) AEs within 21 days following injection • Occurrence of the following reactions (Medical Dictionary for Regulatory Activities [MedDRA] Preferred Terms given in parentheses) in the 3 days following injection will be more specifically reported (as defined by the EMA NfG [CPMP/BWP/214/96]): • Injection site induration =50 mm for at least 4 consecutive days following injection • Injection site ecchymosis (injection site hemorrhage) in the 3 days following injection • Temperature >38°C (pyrexia) for 24 hours or more in the 3 days following injection • Malaise in the 3 days following injection • Shivering (chills) in the 3 days following injection • Occurrence of SAEs including AESIs within the 21 days following vaccination, and up to the end of the trial. Other endpoints recorded or derived will be described in the statistical analysis plan. Depending on the item, these could include: nature (MedDRA preferred term), time of onset, duration, number of days of occurrence, Grade of severity, relationship to vaccine, action taken, whether the AE led to early termination from the study, seriousness, or outcome. Note: The following AESIs, considered as important medical events are to be considered as SAEs and reported to the Sponsor: anaphylaxis, Guillain-Barré syndrome (GBS), encephalitis / myelitis, neuritis, convulsions and vasculitis. Immunogenicity Immunogenicity will be evaluated using the hemagglutination inhibition (HAI) method in all subjects. For each vaccine strai | — |
Countries
Germany
Contacts
Public ContactDirector, Clinical Development
Sanofi Pasteur
Outcome results
None listed