Study with Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared with Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

INTERVENTION: 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 descriptive name: Influenza A virus subtype H1N1 haemagglutinin, recombinant Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 45‐ INN or Proposed INN: rHA protein, derived from Influenza A virus subtype H3N2 Other descriptive name: Influenza A virus subtype H3N2 haemagglutinin, recombinant Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 45‐ INN or Proposed INN: rHA protein, derived from Influenza B virus Victoria lineage Other descriptive name: Influenza B virus Victoria lineage haemagglutinin, recombinant Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 45‐ INN or Proposed INN: rHA protein, derived from Influenza B virus Yamagata lineage Other descriptive name: Influenza B virus Yamagata lineage haemagglutinin, recombinant Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 45‐ Trade Name: Fluari XTetra Product Name: Fluari XTetra Pharmaceutical Form: Suspension for injection in pre‐filled syringe INN or Proposed INN: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) Other descriptive name: A/ H1N1 strain Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 15‐ INN or Proposed INN: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) Other descriptive name: A/ H3N2 strain Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 15‐ INN or Proposed INN: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) Other descriptive name: B/ Victoria lineage strain Concentration unit: µg microgram(s) Concentrat CONDITION: ; MedDRA version: 21.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] 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 PRIMARY OUTCOME: 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; 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 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 Timepoint(s) of evaluation of this end point: 1 and 2: Day 29 or Day 57 SECONDARY OUTCOME: 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);