Influenza
Conditions
Keywords
Influenza, Influenza virus vaccine, Quadrivalent Influenza Virus Vaccine (No Preservative), Fluzone®
Brief summary
The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Objective: * To describe the safety of the 2014-2015 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. Observational objectives: * To describe the immunogenicity of the 2014-2015 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 available sera from each subject to Center for Biologics Evaluation and Research (CBER) for further analysis by the 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 based on the age at the time of enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom 2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose during Visit 2 (28 days after Visit 1). 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 (SAE) information will be collected the study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day 28 after the final vaccination.
Interventions
0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
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 \< 9 years of age. * 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 2014-2015 influenza vaccine. * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator. * Thrombocytopenia, which may be a contraindication for intramuscular 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, 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 |
|---|---|---|
| Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Day 0 up to Day 7 post-any injection | Solicited Injection-site: 6 to \< 36 months - Tenderness, Erythema, and Swelling; 3 to \< 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to \< 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to \< 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, \> 39.5˚C (6 to \< 36 months), ≥ 39.0˚C (3 to \< 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \> 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 post-final vaccination | Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. |
| Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | Day 0 (pre-vaccination) and Day 28 post-final vaccination | Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination. |
| Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | Day 28 post-final vaccination | Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is 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 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | Day 28 post-final vaccination | Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 19 August 2014 to 06 November 2014 at 2 clinical sites in the United States.
Pre-assignment details
A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| 6 to < 36 Months of Age Participants 6 to \< 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine. | 30 |
| 3 to < 9 Years of Age Participants 3 to \< 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | 3 to < 9 Years of Age | 6 to < 36 Months of Age | 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 | 66.9 Months STANDARD_DEVIATION 21.8 | 25.0 Months STANDARD_DEVIATION 8.3 | 45.9 Months STANDARD_DEVIATION 26.7 |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 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 | 22 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 |
Outcome results
Primary
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Solicited Injection-site: 6 to \< 36 months - Tenderness, Erythema, and Swelling; 3 to \< 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to \< 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to \< 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, \> 39.5˚C (6 to \< 36 months), ≥ 39.0˚C (3 to \< 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, \> 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-any injection
Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection-site Swelling | 23.3 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection-site Tenderness (N=30, 0) | 3.3 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection site Pain (N=0, 30) | NA Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection site Pain (N=0, 30) | NA Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection-site Erythema | 50.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection-site Erythema | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection-site Tenderness (N=30, 0) | 70.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection site Swelling (6 to <36 months) | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Fever | 20.7 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Fever | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Vomiting (N=30, 0) | 16.7 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Vomiting (N=30, 0) | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Crying abnormal (N=30, 0) | 33.3 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Crying abnormal (N=30, 0) | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Drowsiness (N=30, 0) | 30.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Drowsiness (N=30, 0) | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Appetite lost (N=30, 0) | 26.7 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Appetite lost | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Irritability (N=30, 0) | 53.3 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Irritability (N=30, 0) | 0.0 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Headache (N=0, 30) | NA Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Headache (N=0, 30) | NA Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Malaise (N=0, 30) | NA Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Malaise (N=0, 30) | NA Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Myalgia (N=0, 30) | NA Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Myalgia (N=0, 30) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Irritability (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection-site Tenderness (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Crying abnormal (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection-site Tenderness (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Myalgia (N=0, 30) | 13.3 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection site Pain (N=0, 30) | 73.3 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Drowsiness (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection site Pain (N=0, 30) | 10.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Headache (N=0, 30) | 10.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection-site Erythema | 66.7 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Drowsiness (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection-site Erythema | 0.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Malaise (N=0, 30) | 0.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Injection-site Swelling | 43.3 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Appetite lost (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Injection site Swelling (6 to <36 months) | 0.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Headache (N=0, 30) | 0.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Fever | 3.3 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Appetite lost | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Fever | 0.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Myalgia (N=0, 30) | 0.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Vomiting (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Irritability (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Grade 3 Vomiting (N=30, 0) | NA Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Malaise (N=0, 30) | 13.3 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | Crying abnormal (N=30, 0) | NA Percentage of participants |
Secondary
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 28 post-final vaccination
Population: Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 6 to < 36 Months of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1 | 10.9 Titer ratio |
| 6 to < 36 Months of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2 | 10.4 Titer ratio |
| 6 to < 36 Months of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata) | 10.0 Titer ratio |
| 6 to < 36 Months of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria) | 18.9 Titer ratio |
| 3 to < 9 Years of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria) | 7.10 Titer ratio |
| 3 to < 9 Years of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1 | 3.30 Titer ratio |
| 3 to < 9 Years of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata) | 5.02 Titer ratio |
| 3 to < 9 Years of Age | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2 | 4.51 Titer ratio |
Secondary
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
Population: Geometric mean titers were assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H1N1; Pre-vaccination | 32.6 Titers (1/dilutions) |
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H1N1; Post-vaccination | 447 Titers (1/dilutions) |
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H3N2; Pre-vaccination | 55.9 Titers (1/dilutions) |
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H3N2; Post-vaccination | 696 Titers (1/dilutions) |
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Yamagata); Pre-vaccination | 56.6 Titers (1/dilutions) |
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Yamagata); Post-vaccination | 617 Titers (1/dilutions) |
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Victoria); Pre-vaccination | 12.5 Titers (1/dilutions) |
| 6 to < 36 Months of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Victoria); Post-vaccination | 352 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Victoria); Post-vaccination | 1136 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H1N1; Pre-vaccination | 361 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Yamagata); Pre-vaccination | 281 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H1N1; Post-vaccination | 1235 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Victoria); Pre-vaccination | 156 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H3N2; Pre-vaccination | 277 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | B (Yamagata); Post-vaccination | 1425 Titers (1/dilutions) |
| 3 to < 9 Years of Age | Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine | A/H3N2; Post-vaccination | 1250 Titers (1/dilutions) |
Secondary
Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
Population: Seroprotection was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1; Pre-vaccination | 44.8 Percentage of participants |
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1; Post-vaccination | 93.1 Percentage of participants |
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2; Pre-vaccination | 62.1 Percentage of participants |
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2; Post-vaccination | 96.6 Percentage of participants |
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata); Pre-vaccination | 55.2 Percentage of participants |
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata); Post-vaccination | 100.0 Percentage of participants |
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria); Pre-vaccination | 17.2 Percentage of participants |
| 6 to < 36 Months of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria); Post-vaccination | 100.0 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria); Post-vaccination | 100.0 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1; Pre-vaccination | 86.2 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata); Pre-vaccination | 89.7 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1; Post-vaccination | 96.6 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria); Pre-vaccination | 82.8 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2; Pre-vaccination | 93.1 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata); Post-vaccination | 100.0 Percentage of participants |
| 3 to < 9 Years of Age | Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2; Post-vaccination | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is 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 28 post-final vaccination
Population: Seroconversion was assessed in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 to < 36 Months of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1 | 86.2 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2 | 89.7 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata) | 86.2 Percentage of participants |
| 6 to < 36 Months of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria) | 89.7 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Victoria) | 69.0 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H1N1 | 34.5 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | B (Yamagata) | 58.6 Percentage of participants |
| 3 to < 9 Years of Age | Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine | A/H3N2 | 58.6 Percentage of participants |