Randomized, Observer-Blind, Active-Controlled, Phase III Study in Adults ≥ 60 years of Age to Assess the Safety and Immunogenicity of Abbott’s Candidate High-Dose Influenza Vaccine.

Influenza immunisation

Postvaccination HI GMTs for each of the three strains 28 days (Day 29) after the first vaccination.

1. Postvaccination HI GMTs for each of the three strains after the revaccination., 2. Postvaccination VN GMTs for each of the three strains after the first and the revaccination., 3. Postvaccination HI and VN geometric mean fold increases (GMFIs) and seroconversion rates after the first and the revaccination., 4. Postvaccination reverse cumulative distribution (RCD) curves for HI and VN titers for each of the three strains after the first and the revaccination., 5. Postvaccination CMI values., 6. Unsolicited (i.e., spontaneously reported) AEs within 28 days following each vaccination, including SAEs, AESIs, MAEs, and NCIs., 7. Serious adverse events, AESIs, MAEs, and NCIs from Day 29 to Month 6 postvaccination (first vaccination only)., 8. Solicited (i.e., prelisted in subject eDiary) injection site adverse reactions and systemic adverse reactions within 7 days following each vaccination. The following adverse reactions will be assessed (injection site): erythema, swelling, induration, pain, and ecchymosis, and (systemic): fever, headache, fatigue, malaise, myalgia, arthralgia, sweating, and shivering.

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