The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety. Objectives: * To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed. * To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations
All subjects will receive one dose of either QIV or TIV on Day 0. They will be monitored for safety and immunogenicity for up to Day 21 post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Ansan-si, South Korea
Unnamed facility
Incheon, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers \< 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.
Time frame: Day 21 post-vaccination
Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature \>38.0˚C for at least 1 day), Malaise, and Shivering (rigors).
Time frame: Day 0 up Day 3 post-vaccination
Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route
Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.
Time frame: Day 0 up Day 7 post-vaccination
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