Influenza
Conditions
Keywords
Influenza, Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine, Influenza viruses, Fluzone®
Brief summary
The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain (B1), and the investigational TIV containing the alternate B (B2) strain in children. Primary Objective: To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among children aged 6 months to less than 9 years of age Secondary Objective: To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates. Observational Objective: To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.
Detailed description
Participants will receive a single dose of their assigned vaccine during Visit 1. For those requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All participants will be followed up for safety (up to 6 months post final vaccination) and for immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate).
Interventions
BIOLOGICALLicensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
BIOLOGICALInvestigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
BIOLOGICALQuadrivalent Influenza Vaccine, No Preservative
0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is 6 months to \< 9 years of age on the day of inclusion. * Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. * Subject is in reasonably good health as assessed by the Investigator. * Informed consent is granted by the parent(s) or other legally acceptable representative; assent by subjects 7 to \< 9 years of age. * For subjects 6 months to \< 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion criteria
* History of allergy to egg proteins or any constituents of the vaccine. * History of serious adverse reaction to any influenza vaccine. * Any vaccination scheduled between Visit 1 and Visit 2 (or Visit 1 and Visit 3 for those requiring two doses). * Receipt of any vaccine in the 4 weeks preceding the first study vaccination. * Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine. * Personal history of Guillain-Barré syndrome. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Personal or immediate family history of congenital immune deficiency. * Personal developmental delay, neurologic disorder, or seizure disorder. * Any chronic illness that, in the opinion of the Investigator, is not well controlled and may interfere with trial conduct or completion, or with assessment of adverse events. * Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C. * Receipt of blood or blood-derived products (including immunoglobulin therapy) in the past 3 months, which might interfere with assessment of the immune response. * Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | Day 28 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | Day 28 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil). |
| Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | Day 28 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil). |
| Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination |
| Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Day 0 up to Day 7 post-vaccination | Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: \>103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable. Solicited Injection site reactions (Age 24 Months to \< 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity. |
| Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Day 0 up to Day 7 post-vaccination | Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively. |
| Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil). |
| Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil) |
| Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre vaccination HAI titer \<1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination. |
| Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre vaccination HAI titer \<1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination. |
| Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | Day 28 post final vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil). |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 11 November 2010 to 20 June 2011 in 69 clinical centers in the US
Pre-assignment details
A total of 4363 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen | 736 |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen | 725 |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) Participants received the Investigational Quadrivalent Influenza Vaccine (QIV) | 2,902 |
| Total | 4,363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 10 |
| Overall Study | Lost to Follow-up | 23 | 20 | 102 |
| Overall Study | Protocol Violation | 24 | 15 | 72 |
| Overall Study | Withdrawal by Subject | 10 | 13 | 59 |
Baseline characteristics
| Characteristic | Study Group 2 (Investigational Trivalent Influenza Vaccine) | Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Total | Study Group 1 (Trivalent Influenza Vaccine) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 725 Participants | 2902 Participants | 4363 Participants | 736 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 49.6 Months STANDARD_DEVIATION 28.7 | 49.8 Months STANDARD_DEVIATION 29.7 | 49.8 Months STANDARD_DEVIATION 29.4 | 49.6 Months STANDARD_DEVIATION 29 |
| Region of Enrollment United States | 725 Participants | 2902 Participants | 4363 Participants | 736 Participants |
| Sex: Female, Male Female | 359 Participants | 1427 Participants | 2153 Participants | 367 Participants |
| Sex: Female, Male Male | 366 Participants | 1475 Participants | 2210 Participants | 369 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 333 / 734 | 329 / 721 | 1,358 / 2,892 |
| serious Total, serious adverse events | 7 / 734 | 14 / 721 | 41 / 2,892 |
Outcome results
Primary
Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 28 post final vaccination
Population: Geometric mean titers (GMT) to influenza vaccine A antigens were determined in randomized and vaccinated participants, per-protocol population. The GMT data for antigen A/Victoria/210/2009 and A/California/07/2009 were pooled for participants vaccinated with either 2010-2011 TIV or the investigational TIV. Data presented in column for Group 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/California/07/2009 (A/H1N1) [N = 1461, 0, 2339] | 1096 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/Victoria/210/2009 (A/H3N2) [N = 1461, 0, 2339 | 828 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/California/07/2009 (A/H1N1) [N = 1461, 0, 2339] | 1124 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/Victoria/210/2009 (A/H3N2) [N = 1461, 0, 2339 | 822 Titers |
Primary
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 28 post final vaccination
Population: Geometric mean titers to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Brisbane/60/2008 (581, 0, 2238) | 64.3 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Florida/04/2006 (0, 598, 2338) | NA Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Brisbane/60/2008 (581, 0, 2238) | NA Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Florida/04/2006 (0, 598, 2338) | 58.3 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Brisbane/60/2008 (581, 0, 2238) | 86.1 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Florida/04/2006 (0, 598, 2338) | 61.5 Titers |
Primary
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 28 post final vaccination
Population: Geometric mean titers to influenza vaccine B antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants | B/Brisbane/60/2008 (0, 599, 2338) | NA Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants | B/Florida/04/2006 (581, 0, 2338) | 16.3 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants | B/Brisbane/60/2008 (0, 599, 2338) | 19.5 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants | B/Florida/04/2006 (581, 0, 2338) | NA Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants | B/Brisbane/60/2008 (0, 599, 2338) | 86.1 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants | B/Florida/04/2006 (581, 0, 2338) | 61.5 Titers |
Primary
Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 28 post-vaccination
Population: Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 Years with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H3N2, Post-vaccination (356, 353, 1390) | 924 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H1N1, Post-vaccination (357, 354, 1390) | 1565 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H1N1, Pre-vaccination (357, 354, 1390) | 53.5 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane, Post-vaccination (356, 354, 1390) | 71.2 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida, Post-vaccination (356, 353, 1390) | 24.4 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H3N2, Pre-vaccination (355, 353, 1389) | 70.6 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane, Pre-vaccination (357, 354, 1390) | 10.1 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida, Pre-vaccination (357, 353, 1390) | 9.09 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane, Post-vaccination (356, 354, 1390) | 27.3 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H1N1, Pre-vaccination (357, 354, 1390) | 54.4 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H3N2, Pre-vaccination (355, 353, 1389) | 64.1 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H3N2, Post-vaccination (356, 353, 1390) | 1214 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida, Pre-vaccination (357, 353, 1390) | 9.84 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H1N1, Post-vaccination (357, 354, 1390) | 1348 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane, Pre-vaccination (357, 354, 1390) | 10.6 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida, Post-vaccination (356, 353, 1390) | 86.9 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida, Pre-vaccination (357, 353, 1390) | 9.34 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H1N1, Post-vaccination (357, 354, 1390) | 1484 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida, Post-vaccination (356, 353, 1390) | 88.5 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H3N2, Post-vaccination (356, 353, 1390) | 1112 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane, Pre-vaccination (357, 354, 1390) | 9.73 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane, Post-vaccination (356, 354, 1390) | 96.6 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H3N2, Pre-vaccination (355, 353, 1389) | 63.9 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | A/H1N1, Pre-vaccination (357, 354, 1390) | 54.9 Titers |
Primary
Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 28 post final vaccination
Population: Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane, Post-vaccination (225, 245, 948) | 54.7 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H3N2, Pre-vaccination (224, 245, 945) | 9.52 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida, Post-vaccination (225, 245, 948) | 8.56 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida, Pre-vaccination (225, 245, 946) | 5.33 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H1N1, Pre-vaccination (224, 245, 943) | 25.6 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane, Pre-vaccination (225, 245, 947) | 6.56 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H3N2, Post-vaccination (224, 243, 944) | 558 Titers |
| Study Group 1 (Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H1N1, Post-vaccination (224, 243, 947) | 797 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida, Pre-vaccination (225, 245, 946) | 5.26 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H1N1, Pre-vaccination (224, 245, 943) | 31.3 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H3N2, Post-vaccination (224, 243, 944) | 583 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane, Pre-vaccination (225, 245, 947) | 6.62 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane, Post-vaccination (225, 245, 948) | 12.0 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida, Post-vaccination (225, 245, 948) | 32.9 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H1N1, Post-vaccination (224, 243, 947) | 645 Titers |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H3N2, Pre-vaccination (224, 245, 945) | 10.1 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida, Post-vaccination (225, 245, 948) | 36.2 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H1N1, Pre-vaccination (224, 245, 943) | 25.7 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane, Pre-vaccination (225, 245, 947) | 6.41 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H3N2, Pre-vaccination (224, 245, 945) | 9.19 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H1N1, Post-vaccination (224, 243, 947) | 747 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida, Pre-vaccination (225, 245, 946) | 5.34 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane, Post-vaccination (225, 245, 948) | 72.8 Titers |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | A/H3N2, Post-vaccination (224, 243, 944) | 526 Titers |
Other Pre-specified
Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 3 years to \<9 years with available data for the relevant endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Erythema (410, 398, 1592) | 151 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Headache (411, 398, 1593) | 87 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Erythema (410, 398, 1592) | 5 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Myalgia (411, 398, 1593) | 140 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Fever (409, 396, 1591) | 5 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Swelling (410, 398, 1592) | 104 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Myalgia (411, 398, 1593) | 11 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Fever (409, 396, 1591) | 29 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Swelling (410, 398, 1592) | 5 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Malaise (411, 398, 1593) | 23 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Pain (410, 398, 1592) | 265 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Malaise (411, 398, 1593) | 135 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Headache (411, 398, 1593) | 11 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Pain (410, 398, 1592) | 8 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Myalgia (411, 398, 1593) | 11 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Erythema (410, 398, 1592) | 140 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Fever (409, 396, 1591) | 3 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Headache (411, 398, 1593) | 97 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Malaise (411, 398, 1593) | 133 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Pain (410, 398, 1592) | 254 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Pain (410, 398, 1592) | 11 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Erythema (410, 398, 1592) | 7 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Swelling (410, 398, 1592) | 103 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Swelling (410, 398, 1592) | 7 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Fever (409, 396, 1591) | 30 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Headache (411, 398, 1593) | 8 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Malaise (411, 398, 1593) | 20 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Myalgia (411, 398, 1593) | 153 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Erythema (410, 398, 1592) | 29 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Fever (409, 396, 1591) | 34 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Erythema (410, 398, 1592) | 543 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Headache (411, 398, 1593) | 368 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Pain (410, 398, 1592) | 1061 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Myalgia (411, 398, 1593) | 615 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Headache (411, 398, 1593) | 35 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Malaise (411, 398, 1593) | 508 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Myalgia (411, 398, 1593) | 52 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Pain (410, 398, 1592) | 33 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Injection site Swelling (410, 398, 1592) | 22 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Injection site Swelling (410, 398, 1592) | 395 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Grade 3 Malaise (411, 398, 1593) | 87 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines | Fever (409, 396, 1591) | 112 Participants |
Other Pre-specified
Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.
Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: \>103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable. Solicited Injection site reactions (Age 24 Months to \< 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 6 months to \<36 months with available data for the relevant endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Headache (128, 148, 517) | 12 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (130, 149, 521) | 1 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Drowsiness (159, 144, 628) | 1 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Fever (288, 293, 1148) | 5 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Tenderness (159, 145, 628) | 77 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Drowsiness (159, 144, 628) | 51 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Vomiting (159, 144, 628) | 18 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Irritability (159, 144, 628) | 5 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Crying abnormal (159, 144, 628) | 3 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Vomiting (159, 144, 628) | 1 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Crying abnormal (159, 144, 628) | 58 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Irritability (159, 144, 628) | 84 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Myalgia (128, 148, 517) | 2 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Myalgia (128, 148, 517) | 34 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Malaise (128, 148, 517) | 45 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade Malaise (128, 148, 517) | 6 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Pain (130, 149, 521) | 68 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Appetite lost (159, 144, 628) | 3 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (289, 294, 1150) | 0 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Tenderness (159, 145, 628) | 3 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Appetite lost (159, 144, 628) | 53 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Swelling (289, 294, 1150) | 57 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Erythema (289, 294, 1150) | 95 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Headache (128, 148, 517) | 0 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (289, 294, 1150) | 0 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Fever (288, 293, 1148) | 46 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Tenderness (159, 145, 628) | 0 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Pain (130, 149, 521) | 75 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (130, 149, 521) | 4 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Vomiting (159, 144, 628) | 0 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Erythema (289, 294, 1150) | 98 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (289, 294, 1150) | 0 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Swelling (289, 294, 1150) | 51 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (289, 294, 1150) | 0 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Fever (288, 293, 1148) | 38 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Fever (288, 293, 1148) | 6 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Vomiting (159, 144, 628) | 20 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Crying abnormal (159, 144, 628) | 43 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Crying abnormal (159, 144, 628) | 3 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Drowsiness (159, 144, 628) | 46 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Drowsiness (159, 144, 628) | 1 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Headache (128, 148, 517) | 18 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Headache (128, 148, 517) | 0 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Appetite lost (159, 144, 628) | 36 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Appetite lost (159, 144, 628) | 1 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Malaise (128, 148, 517) | 48 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade Malaise (128, 148, 517) | 10 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Myalgia (128, 148, 517) | 37 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Myalgia (128, 148, 517) | 4 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Irritability (159, 144, 628) | 77 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Irritability (159, 144, 628) | 4 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Tenderness (159, 145, 628) | 72 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Appetite lost (159, 144, 628) | 203 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Erythema (289, 294, 1150) | 429 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Crying abnormal (159, 144, 628) | 259 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Appetite lost (159, 144, 628) | 11 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Tenderness (159, 145, 628) | 340 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Malaise (128, 148, 517) | 197 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Tenderness (159, 145, 628) | 12 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Irritability (159, 144, 628) | 20 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade Malaise (128, 148, 517) | 24 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Headache (128, 148, 517) | 3 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (130, 149, 521) | 5 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Myalgia (128, 148, 517) | 138 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Vomiting (159, 144, 628) | 93 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Drowsiness (159, 144, 628) | 8 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Crying abnormal (159, 144, 628) | 21 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Fever (288, 293, 1148) | 24 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Vomiting (159, 144, 628) | 6 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Fever (288, 293, 1148) | 164 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Myalgia (128, 148, 517) | 10 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (289, 294, 1150) | 2 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Drowsiness (159, 144, 628) | 237 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Headache (128, 148, 517) | 46 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Swelling (289, 294, 1150) | 248 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Injection site Pain (130, 149, 521) | 297 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (289, 294, 1150) | 2 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines. | Irritability (159, 144, 628) | 339 Participants |
Other Pre-specified
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination
Time frame: Day 28 post final vaccination
Population: Seroconversion with respect to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Brisbane/60/2008 (581, 0, 2336) | 355 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Florida/04/2006 (0, 598, 2335) | NA Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Florida/04/2006 (0, 598, 2335) | 383 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Brisbane/60/2008 (581, 0, 2336) | NA Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Brisbane/60/2008 (581, 0, 2336) | 1677 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants | B/Florida/04/2006 (0, 598, 2335) | 1543 Participants |
Other Pre-specified
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre vaccination HAI titer \<1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination.
Time frame: Day 28 post final vaccination
Population: Seroconversion with respect to influenza vaccine B antigens (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. | B/Brisbane/60/2008 (0, 599, 2336) | NA Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. | B/Florida/04/2006 (581, 0, 2335) | 104 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. | B/Brisbane/60/2008 (0, 599, 2336) | 120 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. | B/Florida/04/2006 (581, 0, 2335) | NA Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. | B/Brisbane/60/2008 (0, 599, 2336) | 1677 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants. | B/Florida/04/2006 (581, 0, 2335) | 1543 Participants |
Other Pre-specified
Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre vaccination HAI titer \<1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination.
Time frame: Day 28 post final vaccination
Population: Seroconversion with respect to vaccine antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 (578, 596, 2329) | 477 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida (581, 598, 2335) | 104 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane (581, 599, 2336) | 355 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 (580, 597, 2331) | 541 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 (578, 596, 2329) | 512 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane (581, 599, 2336) | 120 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida (581, 598, 2335) | 383 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 (580, 597, 2331) | 535 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 (578, 596, 2329) | 2050 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 (580, 597, 2331) | 2135 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane (581, 599, 2336) | 1677 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida (581, 598, 2335) | 1543 Participants |
Other Pre-specified
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)
Time frame: Day 28 post final vaccination
Population: Seroprotection against influenza vaccine antigens was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (581, 598, 2338) | 169 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 Post-vaccination (581, 597, 2337) | 573 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 Pre-vaccination (579, 596, 2334) | 248 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 Post-vaccination (580, 599, 2334) | 575 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination 582, 599, 2337) | 64 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (581, 599, 2338) | 418 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (582, 598, 2336) | 51 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 Pre-vaccination (581, 599, 2333) | 291 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination 582, 599, 2337) | 79 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 Pre-vaccination (581, 599, 2333) | 305 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 Post-vaccination (580, 599, 2334) | 593 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (582, 598, 2336) | 55 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 Post-vaccination (581, 597, 2337) | 585 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (581, 598, 2338) | 416 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (581, 599, 2338) | 202 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 Pre-vaccination (579, 596, 2334) | 241 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (581, 598, 2338) | 1674 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (581, 599, 2338) | 1838 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 Post-vaccination (580, 599, 2334) | 2326 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (582, 598, 2336) | 199 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination 582, 599, 2337) | 261 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H3N2 Pre-vaccination (579, 596, 2334) | 946 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 Pre-vaccination (581, 599, 2333) | 1159 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | A/H1N1 Post-vaccination (581, 597, 2337) | 2305 Participants |
Other Pre-specified
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
Time frame: Day 28 post-vaccination
Population: Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 years with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H1N1 Pre-vaccination (357, 354, 1390) | 211 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H1N1 Post-vaccination (357, 354, 1390) | 353 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H3N2 Pre-vaccination (355, 353, 1389) | 222 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H3N2 Post-vaccination (356, 353, 1390) | 354 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane Pre-vaccination (357, 354, 1390) | 50 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida Pre-vaccination (357, 353, 1390) | 47 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida Post-vaccination (356, 353, 1390) | 150 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane Post-vaccination (356, 354, 1390) | 263 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane Pre-vaccination (357, 354, 1390) | 61 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H1N1 Pre-vaccination (357, 354, 1390) | 205 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H3N2 Post-vaccination (356, 353, 1390) | 351 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida Post-vaccination (356, 353, 1390) | 281 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H1N1 Post-vaccination (357, 354, 1390) | 348 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane Post-vaccination (356, 354, 1390) | 147 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida Pre-vaccination (357, 353, 1390) | 54 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H3N2 Pre-vaccination (355, 353, 1389) | 212 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane Post-vaccination (356, 354, 1390) | 1122 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida Pre-vaccination (357, 353, 1390) | 189 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H3N2 Post-vaccination (356, 353, 1390) | 1383 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Florida Post-vaccination (356, 353, 1390) | 1124 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | B/Brisbane Pre-vaccination (357, 354, 1390) | 200 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H3N2 Pre-vaccination (355, 353, 1389) | 842 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H1N1 Pre-vaccination (357, 354, 1390) | 832 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years. | H1N1 Post-vaccination (357, 354, 1390) | 1380 Participants |
Other Pre-specified
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
Time frame: Day 28 post final vaccination
Population: Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H1N1 Pre-vaccination (224, 245, 943) | 80 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H1N1 Post-vaccination (223, 243, 941) | 220 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H3N2 Pre-vaccination (224, 245, 945) | 26 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H3N2 Post-vaccination (223, 243, 944) | 221 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane Pre-vaccination (225, 245, 947) | 14 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane Post-vaccination (225, 245, 948) | 155 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida Pre-vaccination (225, 245, 946) | 4 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida Post-vaccination (225, 245, 948) | 19 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H3N2 Pre-vaccination (224, 245, 945) | 29 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida Pre-vaccination (225, 245, 946) | 1 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H3N2 Post-vaccination (223, 243, 944) | 242 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane Pre-vaccination (225, 245, 947) | 18 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane Post-vaccination (225, 245, 948) | 55 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H1N1 Pre-vaccination (224, 245, 943) | 100 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H1N1 Post-vaccination (223, 243, 941) | 237 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida Post-vaccination (225, 245, 948) | 135 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H3N2 Pre-vaccination (224, 245, 945) | 104 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H1N1 Post-vaccination (223, 243, 941) | 925 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H1N1 Pre-vaccination (224, 245, 943) | 327 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | H3N2 Post-vaccination (223, 243, 944) | 943 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida Pre-vaccination (225, 245, 946) | 10 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane Post-vaccination (225, 245, 948) | 716 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Brisbane Pre-vaccination (225, 245, 947) | 61 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months. | B/Florida Post-vaccination (225, 245, 948) | 550 Participants |
Other Pre-specified
Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
Time frame: Day 28 post-vaccination
Population: Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Post-vaccination (114, 141, 510) | 111 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Pre-vaccination (112, 141, 510) | 64 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (114, 141, 510) | 18 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Pre-vaccination (114, 141, 510) | 62 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (113, 141, 510) | 46 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination (114, 141, 510) | 15 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Post-vaccination (112, 141, 510) | 110 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (113, 141, 510) | 72 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination (114, 141, 510) | 25 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Pre-vaccination (114, 141, 510) | 89 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Post-vaccination (114, 141, 510) | 139 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (113, 141, 510) | 55 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (114, 141, 510) | 20 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (113, 141, 510) | 98 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Pre-vaccination (112, 141, 510) | 75 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Post-vaccination (112, 141, 510) | 138 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (113, 141, 510) | 341 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Post-vaccination (114, 141, 510) | 498 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Pre-vaccination (112, 141, 510) | 259 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination (114, 141, 510) | 66 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Pre-vaccination (114, 141, 510) | 289 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (114, 141, 510) | 58 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Post-vaccination (112, 141, 510) | 504 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (113, 141, 510) | 350 Participants |
Other Pre-specified
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil).
Time frame: Day 28 post final vaccination
Population: Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Pre-vaccination (467, 458, 1823) | 229 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Post-vaccination (467, 456, 1827) | 462 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Pre-vaccination (467, 457, 1824) | 184 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Post-vaccination (467, 455, 1824) | 465 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination (468, 458, 1827) | 49 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (468, 458, 1828) | 346 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (468, 457, 1826) | 33 Participants |
| Study Group 1 (Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (468, 457, 1828) | 123 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Pre-vaccination (467, 457, 1824) | 166 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Post-vaccination (467, 455, 1824) | 455 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination (468, 458, 1827) | 54 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (468, 457, 1826) | 35 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (468, 457, 1828) | 318 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Pre-vaccination (467, 458, 1823) | 216 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Post-vaccination (467, 456, 1827) | 446 Participants |
| Study Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (468, 458, 1828) | 147 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Pre-vaccination (467, 457, 1824) | 687 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Post-vaccination (467, 456, 1827) | 1807 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H3N2 Post-vaccination (467, 455, 1824) | 1822 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Pre-vaccination (468, 457, 1826) | 141 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | H1N1 Pre-vaccination (467, 458, 1823) | 870 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Pre-vaccination (468, 458, 1827) | 195 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Florida Post-vaccination (468, 457, 1828) | 1324 Participants |
| Study Group 3 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants | B/Brisbane Post-vaccination (468, 458, 1828) | 1497 Participants |