The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age). Primary Objective: * To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants. Secondary Objectives: * To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine (QIV) induce an equivalent immune response at 21 days post-vaccination in both age groups (lot consistency) * To describe the compliance of the immunogenicity of QIV to the European Medicines Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.
All participants will receive a single injection of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2), and also monitored for safety for up to 6 months post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,701
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Melbourne, Australia
Unnamed facility
Westmead NSW, Australia
Unnamed facility
Calamba Laguna City, Philippines
Unnamed facility
City of Muntinlupa, Philippines
Unnamed facility
Malate, Manila, Philippines
Unnamed facility
Quezon City, Philippines
Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Time frame: Day 0 to 7 post-vaccination
Percentage of participants reporting unsolicited systemic reactions including serious adverse events (SAE) throughout the trial.
An SAE is defined as any untoward medical occurrence that at any dose (including overdose): Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability / incapacity; Is a congenital anomaly / birth defect; Is an important medical event.
Time frame: Day 0 up to six months post-vaccination
Percentage of participants with seroprotection and seroconversion post vaccination with either the investigational QIV, or TIV or the licensed 2011-2012 TIV
Immunogenicity assessed by hemagglutination inhibition (HAI) assay for each vaccine strain. Seroprotection defined as a post-vaccination titer of ≥ 40 (1/dil); Seroconversion defined for participants with a pre-vaccination titer \< 10 (1/dil) and a post-vaccination titer of ≥ 40 (1/dil).
Time frame: Day 21 post-vaccination
Level of anti-hemagglutinin antibody titers for each of the 4 strains for each lot of the investigational QIV vaccine.
Time frame: 21 Days post-vaccination
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