Influenza
Conditions
Keywords
Influenza, Influenza vaccine
Brief summary
Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational Objective: To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
Detailed description
This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.
Interventions
BIOLOGICALInfluenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 9 Months
Healthy volunteers
Yes
Inclusion criteria
: * Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion. * Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg. * Considered to be in good health on the basis of reported medical history and history-directed physical examination. * Available for the duration of the study. * Parent/guardian willing and able to provide informed consent. * Parent/guardian able to attend all scheduled visits and comply with all trial procedures. * Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.
Exclusion criteria
: * Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine. * Previous history of influenza vaccination or documented history of influenza infection. * Receipt of any vaccine in the 7 days prior to enrollment. * An acute illness with fever (rectal temperature ≥ 38.0 °C \[or ≥ 100.4 °F\]) in the 72 hours preceding enrollment in the trial (defer enrollment). * Known bleeding disorder. * Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another 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 HIV-positive or HBsAg-positive mother. * Known HIV, hepatitis B (HBsAg), or hepatitis C infection. * Blood or blood-derived products received in 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 |
|---|---|---|
| Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Day 0 to Day 7 post-vaccination | Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). | 21 days post-vaccination 2 | Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40 |
| Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | 21 days post-vaccination 2 | Seroconversion was defined as the percentage of participants with a pre-titer \< 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination. |
| Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | 21 days post-vaccination 2 | Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 08 April to 05 August 2005 in 8 medical centers in the US
Pre-assignment details
A total of 394 participants that met the inclusion and exclusion criteria were enrolled, 393 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Age 6 to 12 Weeks Participants enrolled at 6 to 12 weeks of age | 201 |
| Age 24 to 36 Weeks Participants enrolled at 24 to 36 weeks of age | 192 |
| Total | 393 |
Baseline characteristics
| Characteristic | Age 24 to 36 Weeks | Age 6 to 12 Weeks | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 192 Participants | 201 Participants | 393 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 | 27.0 Weeks STANDARD_DEVIATION 1.31 | 9.4 Weeks STANDARD_DEVIATION 0.98 | 18.0 Weeks STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 192 participants | 201 participants | 393 participants |
| Sex: Female, Male Female | 99 Participants | 98 Participants | 197 Participants |
| Sex: Female, Male Male | 93 Participants | 103 Participants | 196 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 54 / 201 | 94 / 192 |
| serious Total, serious adverse events | 4 / 201 | 3 / 192 |
Outcome results
Primary
Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.
Time frame: Day 0 to Day 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intend-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Loss of Appetite | 43 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Tenderness | 38 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Loss of Appetite (refuses ≥ 3 meals) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Tenderness-Inj. Limb movement reduced | 7 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Irritability | 77 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Tenderness | 50 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Irritability (inconsolable) | 5 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Redness | 16 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Systemic Reaction Dose 2 | 70 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Tenderness-Inj. Limb movement reduced | 1 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Fever (Rectal Temp) | 4 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Redness (≥ 5.0 cm) | 1 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Fever (>39.5 ºC) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Swelling | 8 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Vomiting | 14 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Swelling | 12 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Vomiting (≥ 6 episodes per 24 hrs) | 1 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Redness | 10 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Abnormal Crying | 37 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Abnormal Crying | 4 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Redness | 11 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Drowsiness | 47 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Systemic Reaction Dose 1 | 90 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Drowsiness (difficulty waking up) | 2 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Redness (≥ 5.0 cm) | 1 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Loss of Appetite | 28 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Fever (Rectal Temp) | 8 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Loss of Appetite (refuses ≥ 3 meals) | 1 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Irritability | 55 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Fever (>39.5 ºC) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Irritability (inconsolable) | 3 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Swelling | 5 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Systemic Reaction Any Dose | 92 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Vomiting | 22 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Fever (Rectal Temp) | 11 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Tenderness-Inj. Limb movement reduced | 6 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Fever (>39.5 ºC) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Vomiting (≥ 6 episodes per 24 hrs) | 1 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Vomiting | 27 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Swelling (≥5.0 cm) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Vomiting (≥ 6 episodes per 24 hrs) | 2 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Abnormal Crying | 59 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Abnormal Crying | 66 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Injection Site Reaction - Dose 2 | 41 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Abnormal Crying | 6 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Abnormal Crying | 3 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Drowsiness | 78 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Injection Site Reaction - Any Doses | 61 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Drowsiness (difficulty waking up) | 4 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Drowsiness | 72 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Loss of Appetite | 52 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Loss of Appetite (refuses ≥ 3 meals) | 1 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Drowsiness (difficulty waking up) | 2 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Irritability | 82 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Tenderness | 57 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Irritability (inconsolable) | 7 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Injection Site Reaction - Dose 1 | 54 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Irritability (inconsolable) | 4 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Injection Site Reaction - Dose 1 | 47 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Tenderness | 44 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Tenderness-Inj. Limb movement reduced | 2 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Redness | 7 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Swelling | 5 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Injection Site Reaction - Dose 2 | 27 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Tenderness | 26 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Tenderness-Inj. Limb movement reduced | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Redness | 5 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Swelling | 2 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Swelling (≥5.0 cm) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Injection Site Reaction - Any Doses | 52 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Tenderness | 50 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Tenderness-Inj. Limb movement reduced | 2 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Redness | 10 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Swelling | 6 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Systemic Reaction Dose 1 | 82 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Fever (Rectal Temp) | 18 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Fever (>39.5 ºC) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Vomiting | 16 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Vomiting (≥ 6 episodes per 24 hrs) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Abnormal Crying | 45 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Abnormal Crying | 3 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Drowsiness | 50 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Drowsiness (difficulty waking up) | 1 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Loss of Appetite | 35 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grd 3 Loss of Appetite (refuses ≥ 3 meals) | 2 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Irritability | 67 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Irritability (inconsolable) | 3 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Systemic Reaction Dose 2 | 70 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Fever (Rectal Temp) | 14 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Fever (>39.5 ºC) | 2 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Vomiting | 8 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Vomiting (≥ 6 episodes per 24 hrs) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Abnormal Crying | 34 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Abnormal Crying | 1 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Drowsiness | 38 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Drowsiness (difficulty waking up) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Loss of Appetite | 27 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Loss of Appetite (refuses ≥ 3 meals) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Irritability | 53 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Irritability (inconsolable) | 1 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Solicited Systemic Reaction Any Dose | 89 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Fever (Rectal Temp) | 26 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Fever (>39.5 ºC) | 2 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Vomiting | 21 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Vomiting (≥ 6 episodes per 24 hrs) | 0 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Abnormal Crying | 55 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Abnormal Crying | 4 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Drowsiness | 58 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Drowsiness (difficulty waking up) | 1 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Loss of Appetite | 47 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Grade 3 Loss of Appetite (refuses ≥ 3 meals) | 2 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. | Any Irritability | 76 Percentage of participants |
Other Pre-specified
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.
Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.
Time frame: 21 days post-vaccination 2
Population: GMTs were assessed on the Per-Protocol Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age 6 to 12 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/NEW CALEDONIA/20/99 Pre-dose | 11.5 Titers |
| Age 6 to 12 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/NEW CALEDONIA/20/99 Post-dose | 27.6 Titers |
| Age 6 to 12 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/WYOMING/03/2003 Pre-dose | 40.8 Titers |
| Age 6 to 12 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/WYOMING/03/2003 Post-dose | 46.3 Titers |
| Age 6 to 12 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | B/JIANGSU/10/2003 Pre-dose | 7.0 Titers |
| Age 6 to 12 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | B/JIANGSU/10/2003 Post-dose | 8.4 Titers |
| Age 24 to 36 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | B/JIANGSU/10/2003 Pre-dose | 5.4 Titers |
| Age 24 to 36 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/NEW CALEDONIA/20/99 Pre-dose | 5.7 Titers |
| Age 24 to 36 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/WYOMING/03/2003 Post-dose | 90.9 Titers |
| Age 24 to 36 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/NEW CALEDONIA/20/99 Post-dose | 47.0 Titers |
| Age 24 to 36 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | B/JIANGSU/10/2003 Post-dose | 15.3 Titers |
| Age 24 to 36 Weeks | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. | A/WYOMING/03/2003 Pre-dose | 9.8 Titers |
Other Pre-specified
Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).
Seroconversion was defined as the percentage of participants with a pre-titer \< 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.
Time frame: 21 days post-vaccination 2
Population: Seroconversion analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 to 12 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/NEW CALEDONIA/20/99, Pre-Dose ≤ 10 | 70 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/NEW CALEDONIA/20/99, Pre-Dose ≤10, Post-Dose ≥40 | 48 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/WYOMING/03/2003, Pre-Dose ≤ 10 | 32 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/WYOMING/03/2003, Pre-Dose ≤10, Post-Dose ≥40 | 60 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | FLU B/JIANGSU/10/2003, Pre-Dose ≤ 10 | 84 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | FLU B/JIANGSU/10/2003, Pre-Dose ≤10, Post-Dose ≥40 | 4 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | FLU B/JIANGSU/10/2003, Pre-Dose ≤ 10 | 97 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/NEW CALEDONIA/20/99, Pre-Dose ≤ 10 | 96 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/WYOMING/03/2003, Pre-Dose ≤10, Post-Dose ≥40 | 86 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/NEW CALEDONIA/20/99, Pre-Dose ≤10, Post-Dose ≥40 | 72 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | FLU B/JIANGSU/10/2003, Pre-Dose ≤10, Post-Dose ≥40 | 20 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). | A/WYOMING/03/2003, Pre-Dose ≤ 10 | 74 Percentage of participants |
Other Pre-specified
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).
Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation. Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40
Time frame: 21 days post-vaccination 2
Population: Seroprotection analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 6 to 12 Weeks | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). | A/NEW CALEDONIA/20/99 ≥ 40 Post-dose | 46 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). | A/WYOMING/03/2003 ≥ 40 Post-dose | 59 Percentage of participants |
| Age 6 to 12 Weeks | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). | B/JIANGSU/10/2003 ≥ 40 Post-dose | 5 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). | A/NEW CALEDONIA/20/99 ≥ 40 Post-dose | 69 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). | A/WYOMING/03/2003 ≥ 40 Post-dose | 78 Percentage of participants |
| Age 24 to 36 Weeks | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). | B/JIANGSU/10/2003 ≥ 40 Post-dose | 22 Percentage of participants |