Study analysis
injection-site, redness, myalgia, fatigue, fever, swelling, pain, Redness, Fever, Fatigue
ADVERSE EVENTS, INFLUENZA, INDURATION, SECONDARY, REDNESS, HAND SWELLING, EVENTS, INFLUENZA
Demographic data were expressed as mean, standard deviation, and range values. Analysis of Geometric Mean Titer (GMT), seroprotection, and seroconversion rates between the vaccine groups was performed using Kruskal-Wallis and Chi-square or Kolmogorov-Smirnov tests. Values of The safety analyses were based on the intention-to-treat population analyses. The safety data were collected up to 28 days after the vaccination. The subjects were provided with a diary card to record the appearance, duration, and intensity (mild, moderate, or severe) of any solicited AE (local pain, redness, swelling, induration, fever, fatigue, and myalgia) and unsolicited AE. Local pain was graded as mild (mild pain at the injection-site when touched), moderate (pain with movements), and severe (significant pain at rest). Redness, induration, and swelling intensity were measured using a plastic bangle and categorized as mild (<5 cm), moderate (5–10 cm), and severe (>10 cm). Fever was graded as mild (38.0°C–38.4°C), moderate (38.5°C–38.9°C), and severe (≥39.0°C). Fatigue, myalgia, and unsolicited events were graded as mild (no interference with activity), moderate (some interference with activity), and severe (prevents daily activity, requires medical intervention).The primary outcome was to evaluate the percentage of subjects with anti-HI titer ≥ 1:40, 28 days after Influeza HA vaccination. The secondary outcome was to evaluate geometric mean titres, percentage of subjects with increasing antibody titer ≥ 4 times and/or percentage of subjects with transition of seronegative to seropositive between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9–40 years old and between each batch number of Quadrivalent Influenza HA vaccine and the incidence rate and intensity of adverse events or any serious adverse events within 30 minutes, 72 hour and 28 days after immunization.