The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan Primary Objective: * To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation Secondary Objective: * To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation
Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH 2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for safety for 21 days after injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
0.5 mL, Intramuscular
Unnamed facility
Taipei, Taiwan
Unnamed facility
Taoyuan, Taiwan
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.
Time frame: Day 21 post-vaccination
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \> 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
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Time frame: Day 0 up to Day 7 post-vaccination