Influenza
Conditions
Keywords
Influenza, Influenza virus vaccine, Fluzone® Quadrivalent Influenza Vaccine (No Preservative)
Brief summary
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to \< 9 years at enrollment, divided into 2 age strata (6 months to \< 36 months and 3 years to \< 9 years) Primary Objective: * To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Observational Objectives: * To describe the immunogenicity of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to \< 9 years of age. * To submit sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Detailed description
Participants will be assigned to the appropriate age group (6 months to \< 36 months of age or 3 years to \< 9 years of age) based on the subject's age at the time of enrollment. Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses. Serious adverse event information will be collected from Visit 1 to Visit 2, or Visit 3 for those subjects receiving 2 doses. Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination using the hemagglutination inhibition technique. For each influenza vaccine strain, pre- and post-vaccination geometric mean titers will be calculated.
Interventions
BIOLOGICALFluzone® Quadrivalent Influenza Virus Vaccine, No Preservative
0.25 mL, Intramuscular (Pediatric Dose, 2013-2014 formulation)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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 first study vaccination (study product administration) * Subject and parent/legally acceptable representative are willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study * Assent form has been signed and dated by subjects 7 to \< 9 years of age, and informed consent form has been signed and dated by parent(s) or another legally acceptable representative * For subjects 6 months to \< 12 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs.)
Exclusion criteria
* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) * History of serious adverse reaction to any influenza vaccine * Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 for subjects receiving 1 dose of influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine * Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study * Prior vaccination with any formulation of 2013-2014 influenza vaccine * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator * Thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator * 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 history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F\]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided * Receipt of immune globulins, blood, or blood-derived products in the past 3 months * Identified as a natural or adopted child of the Investigator or an employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Day 0 up to Day 7 post-vaccination | Solicited injection-site reactions (6 months to \<36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, \>103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable. Solicited injection-site reactions (3 years to \< 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 after final vaccination | Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay. |
| Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 after final vaccination | Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution). |
| Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 after final vaccination | Influenza virus antibodies were measured using an HAI assay. 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 ≥ 4-fold increase in post-vaccination titer. |
| Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 after final vaccination | Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccine. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 16 September 2013 to 10 October 2013 at 2 clinic centers in the United States.
Pre-assignment details
A total of 60 participants who met all of the inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Age 6 to <36 Months Group Participants 6 months to \<36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation) | 30 |
| Age 3 to <9 Years Group Participants 3 years to \<9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation) | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Age 3 to <9 Years Group | Age 6 to <36 Months Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Age Continuous | 5.4 Years STANDARD_DEVIATION 1.8 | 1.9 Years STANDARD_DEVIATION 0.6 | 3.7 Years STANDARD_DEVIATION 2.2 |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 30 | 21 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Solicited injection-site reactions (6 months to \<36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, \>103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable. Solicited injection-site reactions (3 years to \< 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all participants who received at least one dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Headache | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Crying abnormal | 10 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site swelling | 7 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Crying abnormal | 3 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Malaise | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Drowsiness | 8 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site swelling | 0 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Drowsiness | 1 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site tenderness | 20 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Appetite lost | 7 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Appetite lost | 2 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site pain | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Irritability | 17 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site tenderness | 5 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Irritability | 3 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site pain | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Headache | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Vomiting | 4 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Fever | 6 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site erythema | 15 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Malaise | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Fever | 0 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Myalgia | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site erythema | 0 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Myalgia | NA Participants |
| Age 6 Months to <36 Months Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Vomiting | 0 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Myalgia | 1 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site erythema | 10 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Vomiting | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Appetite lost | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site tenderness | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site erythema | 1 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site swelling | 7 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site swelling | 1 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site pain | 21 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Injection-site pain | 1 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Fever | 2 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Fever | 0 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Vomiting | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Crying abnormal | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Crying abnormal | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Drowsiness | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Drowsiness | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Appetite lost | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Irritability | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Irritability | NA Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Headache | 4 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Headache | 1 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Malaise | 11 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Grade 3 Malaise | 0 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Myalgia | 13 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | Injection-site tenderness | NA Participants |
Secondary
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccine.
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Population: Geometric mean titer ratios against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age 6 Months to <36 Months Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (N = 25, 28) | 13.9 Titer Ratio |
| Age 6 Months to <36 Months Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (N = 25, 28) | 15.8 Titer Ratio |
| Age 6 Months to <36 Months Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (N = 25, 28) | 5.13 Titer Ratio |
| Age 6 Months to <36 Months Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (N = 25, 28) | 2.87 Titer Ratio |
| Age 3 Years to <9 Years Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (N = 25, 28) | 6.17 Titer Ratio |
| Age 3 Years to <9 Years Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (N = 25, 28) | 8.83 Titer Ratio |
| Age 3 Years to <9 Years Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (N = 25, 28) | 4.70 Titer Ratio |
| Age 3 Years to <9 Years Group | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (N = 25, 28) | 4.82 Titer Ratio |
Secondary
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Population: Geometric mean titers of antibodies against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (pre-vaccination; N = 25, 28) | 14.1 Titers |
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (pre-vaccination; N = 25, 28) | 23.6 Titers |
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (post-vaccination; N = 26, 28) | 484 Titers |
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (post-vaccination; N = 26, 28) | 245 Titers |
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (pre-vaccination; N = 25, 28) | 6.24 Titers |
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (post-vaccination; N = 26, 28) | 48.2 Titers |
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (pre-vaccination; N = 25, 28) | 5.99 Titers |
| Age 6 Months to <36 Months Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (post-vaccination; N = 26, 28) | 24.8 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (post-vaccination; N = 26, 28) | 113 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (post-vaccination; N = 26, 28) | 1264 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (pre-vaccination; N = 25, 28) | 29.0 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (pre-vaccination; N = 25, 28) | 215 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (pre-vaccination; N = 25, 28) | 13.1 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (post-vaccination; N = 26, 28) | 1103 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (pre-vaccination; N = 25, 28) | 136 Titers |
| Age 3 Years to <9 Years Group | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (post-vaccination; N = 26, 28) | 162 Titers |
Secondary
Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Influenza virus antibodies were measured using an HAI assay. 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 ≥ 4-fold increase in post-vaccination titer.
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Population: Seroconversion against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 Months to <36 Months Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (N = 25, 28) | 20 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (N = 25, 28) | 22 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (N = 25, 28) | 17 Participants |
| Age 6 Months to <36 Months Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (N = 25, 28) | 8 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (N = 25, 28) | 17 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (N = 25, 28) | 19 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (N = 25, 28) | 17 Participants |
| Age 3 Years to <9 Years Group | Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (N = 25, 28) | 14 Participants |
Secondary
Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).
Time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Population: Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (pre-vaccination; N = 25, 28) | 8 Participants |
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (post-vaccination; N = 26, 28) | 24 Participants |
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (pre-vaccination; N = 25, 28) | 1 Participants |
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (pre-vaccination; N = 25, 28) | 1 Participants |
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (post-vaccination; N = 26, 28) | 8 Participants |
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (pre-vaccination; N = 25, 28) | 5 Participants |
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (post-vaccination; N = 26, 28) | 22 Participants |
| Age 6 Months to <36 Months Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (post-vaccination; N = 26, 28) | 18 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (post-vaccination; N = 26, 28) | 27 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (pre-vaccination; N = 25, 28) | 24 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (post-vaccination; N = 26, 28) | 22 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H3N2 (post-vaccination; N = 26, 28) | 28 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (post-vaccination; N = 26, 28) | 28 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Yamagata (pre-vaccination; N = 25, 28) | 16 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | A/H1N1 (pre-vaccination; N = 25, 28) | 19 Participants |
| Age 3 Years to <9 Years Group | Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine | B Victoria (pre-vaccination; N = 25, 28) | 6 Participants |