Prophylaxix of influenza in Pregnant Women
Conditions
Interventions
Trade Name: VaxigripTetra
Product Name: VaxigripTetra
Product Code: 481
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: INFLUENZA VACCINE (SPLIT VIRION, INACTI
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged at least 18 years on the day of inclusion - Pregnant women with estimated gestational age of 20 to 32 weeks 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 729 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous vaccination against influenza with the 2017-2018 Northern hemisphere formulation with either the trial vaccines or another vaccine - Pregnancy complications (in the current pregnancy) - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity To demonstrate the non-inferiority of immunogenicity response induced by one dose of VaxigripTetra compared with one dose of Vaxigrip in pregnant women. Safety To describe the safety profile of one dose of VaxigripTetra or Vaxigrip ;Secondary Objective: Immunogenicity -To demonstrate the superiority of the immune response induced by one dose of VaxigripTetra compared with one dose of Vaxigrip for the B strain not contained in Vaxigrip -To describe the immune response induced by one dose of VaxigripTetra or Vaxigrip in pregnant women -To evaluate the transplacental transfer of antibody from mother to newborn from the cord blood after one dose of VaxigripTetra or one dose of Vaxigrip Safety Descriptive analysis of the safety profile of VaxigripTetra and Vaxigrip in terms of pregnancy and birth outcomes ;Primary end point(s): Immunogenicity Hemagglutination inhibition antibody titers obtained on Day (D)21. The GMT will be used as the main parameter Safety -Occurrence of unsolicited systemic adverse events (AEs) reported in the 30 minutes following vaccination -Occurrence of solicited (prelisted in the subject diary card [DC] and the electronic Case Report Form [eCRF]) injection site reactions and systemic reactions occurring between D0 and D7 after vaccination -Occurrence of unsolicited (spontaneously reported) non-serious AEs from D0 to D21 after vaccination -Occurrence of serious adverse events (SAEs) (including adverse events of specific interest [AESIs]) up to delivery ;Timepoint(s) of evaluation of this end point: 21 days after the vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity The derived secondary endpoints for the description of the immune response will be based on D0 and on D21 as follows: -Individual titers on D0 and on D21 -Individual titer ratio D21/D0 -Detectable titer = 10 (1/dilution [1/dil]) on D0 and on D21 -Titer = 40 (1/dil) on D0 and on D21 -Seroconversion or significant increase: Seroconversion: titer < 10 (1/dil) on D0 and post-injection titer = 40 (1/dil) on D21, or significant increase: titer = 10 (1/dil) on D0 and = 4-fold increase of post-injection titer on D21. Safety Pregnancy and birth outcomes will be described. ;Timepoint(s) of evaluation of this end point: - 21 days after the vaccination - At the time of delivery for transplacental transfer of antibodies | — |
Countries
Finland
Contacts
Public ContactGlobal Medical Affairs,
Sanofi Pasteur
Outcome results
None listed