| Primary | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 | Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia. | Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population. | Posted | | Number | | Participants | | Day 0 to Day 3 post-vaccination 1 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
| | | Title | Denominators | Categories |
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| Any Solicited Injection Site Reaction | | | | Any Tenderness | | |
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| Other Pre-specified | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | | Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Day 28 post-single dose or Day 21 post-Dose 2 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
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| Other Pre-specified | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination | | Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group). One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Day 28 post-single dose or Day 21 post-Dose 2 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
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| Other Pre-specified | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months. | Seroprotection post-vaccination were determined in the per-protocol population. One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data. | Posted | | Number | | Percentage of participants | | Day 28 post-single dose or Day 21 post-Dose 2 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
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| Primary | Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 | Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia. | Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group) | Posted | | Number | | Participants | | Day 0 to Day 3 post-vaccination 2 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
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| Other Pre-specified | Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) | Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months. | Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group). One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data. | Posted | | Number | | Percentage of participants | | Day 28 post-single dose or Day 21 post-Dose 2 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
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| Other Pre-specified | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age. | Four-fold rises in vaccine Influenza titers were determined in the per-protocol population. One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data. | Posted | | Number | | Percentage of participants | | Day 28 post-single dose or Day 21 post-Dose 2 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
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| Other Pre-specified | Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) | Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months. | Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group). One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data. | Posted | | Number | | Percentage of participants | | Day 28 post-single dose or Day 21 post-Dose 2 | | | | ID | Title | Description |
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| OG000 | Primed Group | Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1. | | OG001 | Naive/Inadequately Primed Group | Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2. |
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