This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.
Study duration per participant was approximately 28 days for participants with 6 months to \< 9 years of age, and 21 days for participants \>= 65 years of age, including 1 to 3 visits (1 or 2 vaccination visits) and 1 or 2 telephone calls, depending on study Group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
90
Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
Investigational Site Number :8400001
Bardstown, Kentucky, United States
Investigational Site Number :8400002
Salt Lake City, Utah, United States
Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Time frame: Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2 (for participants with 1 vaccination)/Visit 3 (for participants with 2 vaccination)
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and 21 days after vaccination (Visit 2). Collected blood samples were provided to CBER for further analysis by WHO, CDC, and FDA to support formulation recommendations for subsequent influenza vaccines.
Time frame: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)
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