| Primary | Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions | A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability. | Analysis was performed on safety analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Within 7 days post any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| | | Title | Denominators | Categories |
|---|
| Injection site tenderness | | | | Injection site erythema | | | | Injection site swelling | | |
| |
| Primary | Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions | A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia. | Analysis was performed on safety analysis set. | Posted | | Count of Participants | | Participants | | Within 7 days post any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years | Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | | OG001 | Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | | OG002 | Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. |
|
| Primary | Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. | Analysis was performed on per-protocol analysis set which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result for at least 1 strain without any protocol deviations. | Posted | | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | | 28 days post-final vaccination | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | | OG001 | Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years | Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| |
| Primary | Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. | Analysis was performed on per-protocol analysis set. | Posted | | Geometric Mean | 95% Confidence Interval | titers (1/dilutions) | | Day 21 (post-vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | | OG001 | Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. | | OG002 | Fluzone High-Dose Vaccine Group 5: >=65 Years | Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
| |
| Primary | Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine | GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination. | Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 0 (pre-vaccination), 28 days post-final vaccination | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | | OG001 | Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years | Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| |
| Primary | Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine | GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. | Analysis was performed on per-protocol analysis set. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 0 (pre-vaccination), Day 21 (post-vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | | OG001 | Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. | | OG002 | Fluzone High-Dose Vaccine Group 5: >=65 Years | Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
|
| Primary | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination and at post-final vaccination. | Analysis was performed on per-protocol analysis set. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 28 days post-final vaccination | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | | OG001 | Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years | Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| |
| Primary | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer >=40 (1/dilution) at pre-vaccination and at post-final vaccination. | Analysis was performed on per-protocol analysis set. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 21 (post-vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | | OG001 | Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. | | OG002 | Fluzone High-Dose Vaccine Group 5: >=65 Years | Participants (aged >=65 years) received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0. |
|
| Primary | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-final vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-final vaccination titer. | Analysis was performed on per-protocol analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 28 days post-final vaccination | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months | Participants (aged 6 to <36 months) received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. | | OG001 | Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years | Participants (aged 3 to <9 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28. |
| |
| Primary | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-vaccination titer. | Analysis was performed on per-protocol analysis set. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 21 (post-vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Fluzone Quadrivalent Vaccine Group 3: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. | | OG001 | Flublok Quadrivalent Vaccine Group 4: 18 to <65 Years | Participants (aged 18 to <65 years) received a 0.5-mL dose of Flublok Quadrivalent vaccine, intramuscularly, at Day 0. | | OG002 | Fluzone High-Dose Vaccine Group 5: >=65 Years |
|