Influenza
Conditions
Keywords
Influenza, Fluzone® vaccine, Infants, Toddlers
Brief summary
To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months
Detailed description
To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).
Interventions
BIOLOGICALInfluenza Vaccine 2004-2005 Paediatric Formulation
0.25 mL (Day 0 and Day 28), 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 35 Months
Healthy volunteers
Yes
Inclusion criteria
: * Participant is aged ≥ 6 months to \< 36 months. * Participant is considered to be in good health on the basis of reported medical history and limited physical examination. * Participant is available for the duration of the study. * Parent/guardian is willing and able to provide informed consent. * Parent/guardian is willing and able to meet protocol requirements.
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. * An acute illness with or without fever (temperature \> 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment). * Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude). * Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the 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. * Known human immunodeficiency virus (HIV)-positive mother. * 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. * Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Days 0-3 Post-dose | Solicited local reactions: Erythema, bruising, induration, pain at injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | 14 days post-vaccination | — |
| Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | 14 days post-vaccination | Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®. |
| Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | Day 14 post-vaccination | Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®. |
Countries
United States
Participant flow
Recruitment details
The study participants took part in the study from 16 September through 18 November 2004 in 1 US site.
Pre-assignment details
A total of 30 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Infants <12 Months Participants aged ≥ 6 to \< 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively. | 12 |
| Toddlers ≥12 Months Participants aged ≥ 12 to \< 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively. | 18 |
| Total | 30 |
Baseline characteristics
| Characteristic | Toddlers ≥12 Months | Infants <12 Months | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 12 Participants | 30 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 | 20 Months STANDARD_DEVIATION 6 | 8.9 Months STANDARD_DEVIATION 2.1 | 15.6 Months STANDARD_DEVIATION 7.3 |
| Region of Enrollment United States | 18 participants | 12 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 12 | 14 / 18 |
| serious Total, serious adverse events | 0 / 12 | 0 / 18 |
Outcome results
Primary
Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
Solicited local reactions: Erythema, bruising, induration, pain at injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.
Time frame: Days 0-3 Post-dose
Population: Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Induration (>0.5 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Erythema (>0.5 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Erythema (>5.0 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Induration (>0.5 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Induration (>5.0 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Bruising (>0.5 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Bruising (>5.0 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Pain | 3 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Pain (Cry When inj. Limb is Moved) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Local Reaction Post-dose 2 | 4 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Erythema (> 0.5 cm) | 2 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Erythema (>5.0 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Local Reaction Post-dose 1 | 3 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Induration (>5.0 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Bruising (>0.5 cm) | 2 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Bruising (>5.0 cm) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Pain | 4 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Pain (Cry When inj. Limb Is Moved) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Systemic Reaction Post-dose 1 | 7 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Fever | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Fever (>103.1 ºF) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Irritability | 5 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Irritability (>3 hours) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Crying | 3 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Crying (>3 hours) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Lethargy | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Lethargy (Disabling) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Appetite Decreased | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Appetite Decreased (refuses over 3 feeds) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Vomiting | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Vomiting (3 or more episodes) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Diarrhea | 3 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Diarrhea (>5 Diarrhea Stools) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Rash - Presence of Welts | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Systemic Reaction Post-dose 2 | 6 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Fever | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Fever (>103.1 ºF) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Irritability | 5 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Irritability (>3 hours) | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Crying | 4 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Crying (>3 hours) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Lethargy | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Lethargy (Disabling) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Appetite Decreased | 3 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Appetite Decreased (refuses 3 feeds) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Vomiting | 1 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Vomiting (3 or more episodes) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Diarrhea | 3 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Diarrhea (>5 Diarrhea Stools) | 0 Participants |
| Infants <12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Rash - Presence of Welts | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Irritability | 6 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Local Reaction Post-dose 1 | 7 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Lethargy | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Erythema (>0.5 cm) | 2 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Diarrhea (>5 Diarrhea Stools) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Erythema (>5.0 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Lethargy (Disabling) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Induration (>0.5 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Irritability (>3 hours) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Induration (>5.0 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Appetite Decreased | 4 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Bruising (>0.5 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Appetite Decreased (refuses 3 feeds) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Bruising (>5.0 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Appetite Decreased (refuses over 3 feeds) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Pain | 5 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Crying | 3 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Pain (Cry When inj. Limb is Moved) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Vomiting | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Local Reaction Post-dose 2 | 4 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Diarrhea | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Erythema (> 0.5 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Vomiting (3 or more episodes) | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Erythema (>5.0 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Crying (>3 hours) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Induration (>0.5 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Diarrhea | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Induration (>5.0 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Vomiting | 2 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Bruising (>0.5 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Diarrhea (>5 Diarrhea Stools) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Bruising (>5.0 cm) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Lethargy | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Pain | 4 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Rash - Presence of Welts | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Pain (Cry When inj. Limb Is Moved) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Rash - Presence of Welts | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Systemic Reaction Post-dose 1 | 12 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Solicited Systemic Reaction Post-dose 2 | 10 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Fever | 3 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Lethargy (Disabling) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Fever (>103.1 ºF) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Fever | 3 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Irritability | 9 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Vomiting (3 or more episodes) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Irritability (>3 hours) | 1 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Fever (>103.1 ºF) | 0 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Crying | 6 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Any Appetite Decreased | 6 Participants |
| Toddlers ≥12 Months | Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation | Grade 3 Crying (>3 hours) | 0 Participants |
Other Pre-specified
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation
Time frame: 14 days post-vaccination
Population: GMTs were evaluated in the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infants <12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/Wyoming/03/2003, Pre-dose | 7.9 Titers |
| Infants <12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | B/Jiangsu/10/2003, Pre-dose | 5.0 Titers |
| Infants <12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/New Caledonia/20/99, Post-dose | 15.0 Titers |
| Infants <12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | B/Jiangsu/10/2003, Post-dose | 7.5 Titers |
| Infants <12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/Wyoming/03/2003, Post-dose | 31.7 Titers |
| Infants <12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/New Caledonia/20/99, Pre-dose | 7.9 Titers |
| Toddlers ≥12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/Wyoming/03/2003, Post-dose | 108.9 Titers |
| Toddlers ≥12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/New Caledonia/20/99, Post-dose | 26.2 Titers |
| Toddlers ≥12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/Wyoming/03/2003, Pre-dose | 14.4 Titers |
| Toddlers ≥12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | A/New Caledonia/20/99, Pre-dose | 9.4 Titers |
| Toddlers ≥12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | B/Jiangsu/10/2003, Pre-dose | 5.0 Titers |
| Toddlers ≥12 Months | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation | B/Jiangsu/10/2003, Post-dose | 8.4 Titers |
Other Pre-specified
Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)
Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.
Time frame: Day 14 post-vaccination
Population: Seroconversion were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants <12 Months | Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | A/New Caledonia/20/99 | 33 Percentage of Participants |
| Infants <12 Months | Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | A/Wyoming/03/2003 | 58 Percentage of Participants |
| Infants <12 Months | Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | B/Jiangsu/10/2003 | 8 Percentage of Participants |
| Toddlers ≥12 Months | Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | A/New Caledonia/20/99 | 50 Percentage of Participants |
| Toddlers ≥12 Months | Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | A/Wyoming/03/2003 | 100 Percentage of Participants |
| Toddlers ≥12 Months | Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion) | B/Jiangsu/10/2003 | 17 Percentage of Participants |
Other Pre-specified
Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)
Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.
Time frame: 14 days post-vaccination
Population: Seroprotection were evaluated in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants <12 Months | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/New Caledonia/20/99 | 8 Percentage of Participants |
| Infants <12 Months | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/Wyoming/03/2003 | 50 Percentage of Participants |
| Infants <12 Months | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | B/Jiangsu/10/2003 | 8 Percentage of Participants |
| Toddlers ≥12 Months | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/New Caledonia/20/99 | 39 Percentage of Participants |
| Toddlers ≥12 Months | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/Wyoming/03/2003 | 67 Percentage of Participants |
| Toddlers ≥12 Months | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | B/Jiangsu/10/2003 | 0 Percentage of Participants |