The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
All participants received 1 intramuscular injection of the study vaccine associated with their assigned group at Visit 1. For participants 6 months to \< 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second intramuscular injection of Fluzone Quadrivalent vaccine was administered at Visit 2 (28 days after Visit 1). Blood specimens were obtained from all participants prior to the first vaccination: * At Visit 1 (Day 0) and 28 days following the final vaccination (Visit 2, if no study vaccine was administered at Visit 2; or Visit 3, if a second dose of study vaccine was administered at Visit 2), for participants 6 months to \< 9 years of age (Group 1 and Group 2) * At Visit 1 and 21 (window, 21-28) days post-vaccination (Visit 2), for participants greater than or equal to (\>=) 65 years of age (Group 3) Serious Adverse Events (SAEs), suspected unexpected serious adverse reactions (SUSARs), or Adverse Event of Special Interests (AESIs) were collected from Visit 1 through Visit 2 for participants receiving 1 dose of study vaccine, and from Visit 1 through Visit 3 for participants receiving 2 doses of study vaccine. Study duration per participant was approximately 28 days for participants 6 months to less than (\<) 9 years of age, and 21 days for participants \>= 65 years of age.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
90
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Investigational Site Number 8400002
Bardstown, Kentucky, United States
Investigational Site Number 8400001
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 before first vaccination at Visit 1 (Day 0; 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 0; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3
Number of Participants Aged >= 65 Years Who Provided Serum Samples for Analysis: Group 3
Blood samples were collected from participants before vaccination at Visit 1 (Day 0; 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 0; pre-vaccination) and 21 days post-vaccination (Visit 2)
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