MedDRA version: 21.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Supemtek
Product Name: Supemtek
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: rHA protein, derived from Influenza A virus subtype H1N1
Other descr
Sponsors
Sanofi Pasteur Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 3 to 8 years on the day of inclusion - Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations Are the trial subjects under 18? yes Number of subjects for this age range: 1412 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - 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 - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment - Personal or family history of Guillain-Barré Syndrome (GBS) - Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferior (NI) HAI immune response of RIV4 vs licensed IIV4 for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years ;Secondary Objective: • To summarize the HAI immune response induced by RIV4 and IIV4 for the 4 strains based on the egg-derived antigen in participants aged 3 to 8 years • To assess the safety profile of each vaccine in all participants and by age group;Primary end point(s): 1- Individual Hemagglutination inhibition (HAI) titer at D29 after vaccination: Antibody titers are expressed as GMTs 2- Percentage of participants achieving seroconversion: Seroconversion for participants with a pre-vaccination titer lower than (<) 10 [1/dil] at D01 and a post-vaccination titer = 40 [1/dil] at D29 or D57, or a pre-vaccination titer = 10 [1/dil] at D1 and a = 4-fold increase in post-vaccination titer at D29 or D57;Timepoint(s) of evaluation of this end point: 1 and 2: Day 29 or Day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Individual Hemagglutination inhibition (HAI) titer at Day01 and at D29 after vaccination 2- Percentage of participants with detectable antibody titers greater than or equal to (=) 10 [1/dil] 3- Percentage of participants with antibody titers greater than or equal to (=) 40 [1/dil] 4- Occurrence of immediate adverse events (AEs): Immediate adverse events include unsolicited systemic adverse events within 30 minutes after vaccination 5- Occurrence of solicited injection site reactions and systemic reactions: Adverse reactions pre-listed in the (electronic) case report book (CRB) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia 6- Occurrence of unsolicited AEs: AEs that other than solicited reactions 7- Occurrence of attended adverse event (MAAEs) 8- Occurrence of serious adverse events (SAEs): SAEs, including adverse event of special interest (AESIs);Timepoint(s) of evaluation of this end point: 1, 2 and 3: Day 1 and Day 29 or Day 57 4: Within 30 minutes after each vaccination 5: Within 8 days after each vaccination 6 and 7: Up to 28 days after each vaccination 8: From Day 1 until the EoS (up to 6 months after vaccination) | — |
Countries
Bulgaria, Czechia, Czech Republic, Denmark, Poland, Spain, United States
Contacts
Public ContactTrial Transparency Team
Sanofi Pasteur Inc.
Outcome results
None listed