Influenza
Conditions
Keywords
Fluzone® vaccine, Influenza
Brief summary
The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: * To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
Detailed description
This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.
Interventions
BIOLOGICALInfluenza Virus Vaccine
0.25 mL, Intramuscular
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 11 Months
Healthy volunteers
Yes
Inclusion criteria
* Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth). * Available for the duration of the study. * Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg * Parent/legal acceptable representative willing and able to provide informed consent. * Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures. * Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample. * Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.
Exclusion criteria
* Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine. * Previous history of influenza vaccination (Group 2 subjects only). * Receipt of any vaccine in the 14 days prior to enrollment. * An acute illness with or without fever (rectal temperature ≥ 38.0 °C \[or ≥100.4 °F\]) in the 72 hours preceding enrollment in the trial. * Known bleeding disorder. * Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in this study. * Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. * Personal or immediate family history of congenital immune deficiency. * Developmental delay, neurologic disorder, or seizure disorder. * Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion. * Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother. * Known HIV, hepatitis B, or hepatitis C infection. * Receipt of blood or blood-derived products within the past 2 months. * Prior history of Guillain-Barré syndrome. * Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | Day 28 Post-vaccination | Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | Day 28 Post-vaccination | Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method. |
| Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Day 28 Post-vaccination | Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA). Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method. The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay. |
| Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Day 28 post-vaccination | Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA). |
| Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Day 28 post-vaccination | Antibodies to polio viruses were measured by a serum neutralization assay. |
| Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Days 0 up to 7 post-vaccination | Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 17 October 2005 to 05 January 2006 at 7 medical centers in the US.
Pre-assignment details
A total of 242 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone® Vaccine-Primed Group Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. | 112 |
| Influenza Vaccine-Naive Group Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. | 130 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 8 |
Baseline characteristics
| Characteristic | Influenza Vaccine-Naive Group | Fluzone® Vaccine-Primed Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 130 Participants | 112 Participants | 242 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 | 7.28 Months STANDARD_DEVIATION 1.47 | 7.29 Months STANDARD_DEVIATION 1.1 | 7.28 Months STANDARD_DEVIATION 1.3 |
| Region of Enrollment United States | 130 participants | 112 participants | 242 participants |
| Sex: Female, Male Female | 60 Participants | 53 Participants | 113 Participants |
| Sex: Female, Male Male | 70 Participants | 59 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 112 | 56 / 130 |
| serious Total, serious adverse events | 5 / 112 | 1 / 130 |
Outcome results
Primary
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Time frame: Day 28 Post-vaccination
Population: Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine-Primed Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 1 | 44 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 1 | 31 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 1 | 22 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 2 | 69 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 2 | 84 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 2 | 28 Percentage of Participants |
| Influenza Vaccine-Naive Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 2 | 100 Percentage of Participants |
| Influenza Vaccine-Naive Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 1 | 34 Percentage of Participants |
| Influenza Vaccine-Naive Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 2 | 86 Percentage of Participants |
| Influenza Vaccine-Naive Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 1 | 74 Percentage of Participants |
| Influenza Vaccine-Naive Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 2 | 47 Percentage of Participants |
| Influenza Vaccine-Naive Group | Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 1 | 6 Percentage of Participants |
Other Pre-specified
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.
Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA). Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method. The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.
Time frame: Day 28 Post-vaccination
Population: GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Pertussis Toxoid (EU/mL) | 57.9 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Filamentous Hemagglutinin (EU/mL) | 37.3 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Pertactin (EU/mL) | 22.0 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Fimbriae Types 2 and 3 (EU/mL) | 26.7 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Diphtheria (IU/mL) | 0.230 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Tetanus (IU/mL) | 0.976 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Diphtheria (IU/mL) | 0.251 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Pertussis Toxoid (EU/mL) | 69.5 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Fimbriae Types 2 and 3 (EU/mL) | 11.6 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Filamentous Hemagglutinin (EU/mL) | 47.3 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Tetanus (IU/mL) | 0.980 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. | Pertactin (EU/mL) | 33.6 Titers |
Other Pre-specified
Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Antibodies to polio viruses were measured by a serum neutralization assay.
Time frame: Day 28 post-vaccination
Population: Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polio Type 2 (1/dil) | 356 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polio Type 3 (1/dil) | 394 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polio Type 1 (1/dil) | 555 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polio Type 1 (1/dil) | 1072 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polio Type 2 (1/dil) | 550 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polio Type 3 (1/dil) | 571 Titers |
Other Pre-specified
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).
Time frame: Day 28 post-vaccination
Population: Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polyribosylribitol Phosphate (mcg/mL) | 1.69 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 4 (mcg/mL) | 1.02 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 6B (mcg/mL) | 1.14 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 9V (mcg/mL) | 0.974 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 14 (mcg/mL) | 4.98 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 18C (mcg/mL) | 0.783 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 19F (mcg/mL) | 1.49 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 23F (mcg/mL) | 0.920 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 23F (mcg/mL) | 1.00 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Polyribosylribitol Phosphate (mcg/mL) | 2.12 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 14 (mcg/mL) | 5.54 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 4 (mcg/mL) | 0.956 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 19F (mcg/mL) | 1.26 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 6B (mcg/mL) | 1.24 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 18C (mcg/mL) | 0.790 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. | Pneumococcal 9V (mcg/mL) | 1.20 Titers |
Other Pre-specified
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Time frame: Day 28 Post-vaccination
Population: Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 1 | 21.4 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 1 | 30.5 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 2 | 78.9 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 1 | 13.2 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 2 | 20.7 Titers |
| Fluzone® Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 2 | 38.1 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 2 | 23.9 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 1 | 18.9 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 1 | 65.6 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | B/Jiangsu/310/2003 Post-Dose 1 | 6.2 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New Caledonia/20/99 Post-Dose 2 | 104 Titers |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. | A/New York/55/2004 Post-Dose 2 | 277 Titers |
Other Pre-specified
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
Time frame: Days 0 up to 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Loss of Appetite | 39 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Tenderness | 34 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Tenderness (injected limb movement reduced) | 2 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Irritability | 65 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Tenderness | 40 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Irritability (inconsolable) | 2 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Redness (> 0.5 cm) | 16 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Systemic Reaction Post-Dose 2 | 64 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Tenderness (injected limb movement reduced) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Fever | 14 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Redness (≥ 5.0 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Fever (≥ 103.3 ºF) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Swelling (> 0.5 cm) | 9 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Vomiting | 8 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Swelling (> 0.5 cm) | 13 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Redness (> 0.5 cm) | 12 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Abnormal Crying | 39 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Swelling (≥ 5.0 cm) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Abnormal Crying (> 3 hours) | 2 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Redness (> 0.5 cm) | 11 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Drowsiness | 29 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Systemic Reaction Post-Dose 1 | 79 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Drowsiness (difficulty waking up) | 0 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Redness ≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Loss of Appetite | 29 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Fever | 25 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) | 0 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Swelling (≥ 5.0 cm) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Irritability | 56 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Fever ≥ 103.3 ºF) | 0 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Irritability (inconsolable) | 3 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Swelling (> 0.5 cm) | 10 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Systemic Reaction - Any Dose | 86 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Vomiting | 14 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Fever | 32 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Tenderness (injected limb movement reduced) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Fever (≥ 103.3 ºF) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Vomiting | 20 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Swelling (≥ 5.0 cm) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Abnormal Crying | 46 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Abnormal Crying | 55 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Injection Site Reaction Post-Dose 2 | 36 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Abnormal Crying (> 3 hours) | 6 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Abnormal Crying (> 3 hours) | 5 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Drowsiness | 53 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Injection Site Reaction - Any Dose | 51 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Drowsiness (difficulty waking up) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Drowsiness | 47 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Loss of Appetite | 52 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Redness (≥ 5.0 cm) | 2 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Drowsiness (difficulty waking up) | 1 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Irritability | 76 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Tenderness | 48 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Irritability (inconsolable) | 4 Percentage of Participants |
| Fluzone® Vaccine-Primed Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Injection Site Reaction Post-Dose 1 | 45 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Irritability (inconsolable) | 2 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Injection Site Reaction Post-Dose 1 | 42 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Tenderness | 40 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Tenderness (injected limb movement reduced) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Redness (> 0.5 cm) | 14 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Redness (≥ 5.0 cm) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Swelling (> 0.5 cm) | 7 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Injection Site Reaction Post-Dose 2 | 34 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Tenderness | 28 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Tenderness (injected limb movement reduced) | 0 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Redness (> 0.5 cm) | 10 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Redness ≥ 5.0 cm) | 0 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Swelling (> 0.5 cm) | 5 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Injection Site Reaction - Any Dose | 51 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Tenderness | 45 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Tenderness (injected limb movement reduced) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Redness (> 0.5 cm) | 19 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Redness (≥ 5.0 cm) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Swelling (> 0.5 cm) | 10 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Systemic Reaction Post-Dose 1 | 82 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Fever | 25 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Fever ≥ 103.3 ºF) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Vomiting | 7 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Abnormal Crying | 32 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Abnormal Crying (> 3 hours) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Drowsiness | 45 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Drowsiness (difficulty waking up) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Loss of Appetite | 33 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) | 0 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Irritability | 63 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Irritability (inconsolable) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Systemic Reaction Post-Dose 2 | 62 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Fever | 14 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Fever (≥ 103.3 ºF) | 2 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Vomiting | 12 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 3 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Abnormal Crying | 26 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Abnormal Crying (> 3 hours) | 3 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Drowsiness | 34 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Drowsiness (difficulty waking up) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Loss of Appetite | 28 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Irritability | 43 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Irritability (inconsolable) | 3 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Solicited Systemic Reaction - Any Dose | 90 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Fever | 34 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Fever (≥ 103.3 ºF) | 2 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Vomiting | 16 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 2 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Abnormal Crying | 45 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Abnormal Crying (> 3 hours) | 3 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Drowsiness | 53 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grade 3 Drowsiness (difficulty waking up) | 2 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Loss of Appetite | 43 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds) | 1 Percentage of Participants |
| Influenza Vaccine-Naive Group | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Any Irritability | 71 Percentage of Participants |