Influenza
Conditions
Keywords
Influenza Vaccine, Influenza Virus, Orthomyxoviridae Infections, Fluzone®
Brief summary
To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Interventions
BIOLOGICAL2007-2008 Influenza 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 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Participant is aged ≥ 6 months (24 weeks) to \< 36 months (3rd birthday). * 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/legal acceptable representative is willing and able to provide informed consent. * Parent/legal acceptable representative is willing and able to meet protocol requirements. * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion criteria
* Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine. * An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred). * Clinically significant findings in vital signs or review of systems (Investigator judgment; defer or exclude). * Participation in any other interventional clinical trial within 30 days prior to enrollment or planned 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 personal 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. * Received any vaccinations within the preceding 14 days (enrollment may be deferred).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Days 0-3 post-dose | Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | Day 0 and Day 14 after last dose of Fluzone | — |
| Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | Day 14 post-vaccination | Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40. |
| Seroconversion Rates for Each Influenza Antigen Post-Vaccination | Day 14 post-vaccination | Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer \< 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 29 October 2007 through 27 November 2007 at 1 US site.
Pre-assignment details
A total of 34 participants who met the inclusion and exclusion criteria were enrolled, 2 were not vaccinated and excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Influenza Vaccine Naive/Inadequately Primed Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14. | 23 |
| Influenza Vaccine Primed Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0. | 9 |
| Total | 32 |
Baseline characteristics
| Characteristic | Influenza Vaccine Primed | Influenza Vaccine Naive/Inadequately Primed | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 23 Participants | 32 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 | 24.5 Months STANDARD_DEVIATION 5.1 | 19.8 Months STANDARD_DEVIATION 8.76 | 21.2 Months STANDARD_DEVIATION 8.11 |
| Region of Enrollment United States | 9 participants | 23 participants | 32 participants |
| Sex: Female, Male Female | 4 Participants | 13 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 23 | 3 / 9 |
| serious Total, serious adverse events | 0 / 23 | 0 / 9 |
Outcome results
Primary
Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.
Time frame: Days 0-3 post-dose
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Irritability | 7 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Injection Site Reaction Post-dose 1 | 13 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Tenderness | 9 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Tenderness (Cries when limb is moved) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Pain | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Redness (> 0.5 cm) | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Redness (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Swelling (> 0.5 cm) | 2 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Injection Site Reaction Post-dose 2 | 7 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Tenderness | 6 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Tenderness (Cries when limb is moved) | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Pain | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Redness (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Redness) (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Swelling (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Injection Reaction - Any dose | 14 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Tenderness | 10 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Tenderness (Cries when limb moved) | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Pain | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Redness (> 0.5 cm) | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Redness (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Swelling (> 0.5 cm) | 2 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Systemic Reaction Post-dose 1 | 14 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Fever | 4 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Fever (>103.1 ºF) | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Vomiting | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Vomiting (≥ episodes per 24 hr) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Abnormal Crying | 9 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Abnormal Crying (> 3 hr) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Drowsiness | 7 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Drowsiness (Sleeps most of the time) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Loss of Appetite | 7 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Loss of Appetite (Refuses most feeds) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Irritability | 11 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Irritability (Inconsolable) | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Headache | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Myalgia | 2 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Malaise | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Systemic Reaction Post-dose 2 | 11 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Fever | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Fever (> 103ºF) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Vomiting | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Abnormal Crying | 5 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Abnormal Crying (>3 hr) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Drowsiness | 5 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Drowsiness (Sleeps most of time) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Loss of Appetite | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Loss of Appetite (Refuses most feeds) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Headache | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Myalgia | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Malaise | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Systemic Reaction (Any dose) | 16 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Fever | 6 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Fever (> 103.1 ºF) | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Vomiting | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Abnormal Crying | 10 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Abnormal Crying (> 3 hr) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Drowsiness | 8 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Drowsiness (Sleeps most of the time) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Loss of Appetite | 9 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Loss of Appetite (Refuses most feeds) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Irritability | 12 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Irritability (Inconsolable) | 1 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Headache | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Headache (Prevents activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Myalgia | 2 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Myalgia (Prevents activities) | 0 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Malaise | 3 Participants |
| Influenza Vaccine Naive/Inadequately Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Malaise (Prevents activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Malaise | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Injection Site Reaction Post-dose 1 | 4 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Myalgia | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Tenderness | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Myalgia (Prevents activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Tenderness (Cries when limb is moved) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Pain | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Malaise | 3 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Redness (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Loss of Appetite | 1 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Redness (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Malaise (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Swelling (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Systemic Reaction (Any dose) | 6 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Systemic Reaction Post-dose 2 | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Injection Site Reaction Post-dose 2 | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Headache (Prevents activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Tenderness | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Fever | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Tenderness (Cries when limb is moved) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Fever | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Pain | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Fever (> 103ºF) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grd 3 Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Loss of Appetite (Refuses most feeds) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Redness (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Vomiting | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Redness) (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Fever (> 103.1 ºF) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Swelling (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Malaise (Prevents activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Injection Reaction - Any dose | 4 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Abnormal Crying | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Tenderness | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Vomiting | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Tenderness (Cries when limb moved) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Abnormal Crying (>3 hr) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Pain | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Irritability | 3 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Drowsiness | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Redness (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Vomiting (≥ 6 episodes per 24 hr) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Redness (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Drowsiness (Sleeps most of time) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Swelling (> 0.5 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Myalgia | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Loss of Appetite | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Solicited Systemic Reaction Post-dose 1 | 6 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Abnormal Crying | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Fever | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Loss of Appetite (Refuses most feeds) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Fever (>103.1 ºF) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Irritability | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Vomiting | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Vomiting (≥ episodes per 24 hr) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Abnormal Crying | 2 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Abnormal Crying (> 3 hr) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Abnormal Crying (> 3 hr) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Headache | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Drowsiness | 3 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Malaise | 3 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Drowsiness (Sleeps most of the time) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Headache (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Loss of Appetite | 1 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Drowsiness | 3 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Loss of Appetite (Refuses most feeds) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Myalgia | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Irritability | 3 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Headache | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Myalgia (Prevents daily activities) | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Any Headache | 0 Participants |
| Influenza Vaccine Primed | Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation | Grade 3 Drowsiness (Sleeps most of the time) | 0 Participants |
Other Pre-specified
Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination
Time frame: Day 0 and Day 14 after last dose of Fluzone
Population: The Geometric Mean Titers analysis were on the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza Vaccine Naive/Inadequately Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | A/Solomon Islands/3/2006 IVR-145 (H1N1) Pre-dose | 8.31 Titers |
| Influenza Vaccine Naive/Inadequately Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | A/Solomon Islands/3/2006 IVR-145 (H1N1) Post-dose | 397 Titers |
| Influenza Vaccine Naive/Inadequately Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | A/Wisconsin/67/2005 (X-161B) (H3N2) Pre-dose | 10.7 Titers |
| Influenza Vaccine Naive/Inadequately Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | Wisconsin/67/2005 (X161B) (H3N2) Post-dose | 260 Titers |
| Influenza Vaccine Naive/Inadequately Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | B/Malaysia Split/2506/2004 Pre-dose | 12.3 Titers |
| Influenza Vaccine Naive/Inadequately Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | B/Malaysia Split/2506/2004 Post-dose | 186 Titers |
| Influenza Vaccine Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | B/Malaysia Split/2506/2004 Pre-dose | 13.3 Titers |
| Influenza Vaccine Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | A/Solomon Islands/3/2006 IVR-145 (H1N1) Pre-dose | 5.61 Titers |
| Influenza Vaccine Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | Wisconsin/67/2005 (X161B) (H3N2) Post-dose | 479 Titers |
| Influenza Vaccine Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | A/Solomon Islands/3/2006 IVR-145 (H1N1) Post-dose | 180 Titers |
| Influenza Vaccine Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | B/Malaysia Split/2506/2004 Post-dose | 180 Titers |
| Influenza Vaccine Primed | Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination | A/Wisconsin/67/2005 (X-161B) (H3N2) Pre-dose | 59.9 Titers |
Other Pre-specified
Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)
Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.
Time frame: Day 14 post-vaccination
Population: The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Vaccine Naive/Inadequately Primed | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | B/Malaysia Split/2506/2004 | 81 Percentage of Participants |
| Influenza Vaccine Naive/Inadequately Primed | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/Solomon Islands/3/2006 IVR-145 (H1N1) | 100 Percentage of Participants |
| Influenza Vaccine Naive/Inadequately Primed | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/Wisconsin/67/2005 (X-161B) (H3N2) | 100 Percentage of Participants |
| Influenza Vaccine Primed | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/Solomon Islands/3/2006 IVR-145 (H1N1) | 83 Percentage of Participants |
| Influenza Vaccine Primed | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | A/Wisconsin/67/2005 (X-161B) (H3N2) | 100 Percentage of Participants |
| Influenza Vaccine Primed | Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) | B/Malaysia Split/2506/2004 | 100 Percentage of Participants |
Other Pre-specified
Seroconversion Rates for Each Influenza Antigen Post-Vaccination
Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer \< 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.
Time frame: Day 14 post-vaccination
Population: The seroconversion analysis were on the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Vaccine Naive/Inadequately Primed | Seroconversion Rates for Each Influenza Antigen Post-Vaccination | A/Solomon Islands/3/2006 IVR-145 (H1N1) | 100 Percentage of Participants |
| Influenza Vaccine Naive/Inadequately Primed | Seroconversion Rates for Each Influenza Antigen Post-Vaccination | A/Wisconsin/67/2005 (X-161B) (H3N2) | 79 Percentage of Participants |
| Influenza Vaccine Naive/Inadequately Primed | Seroconversion Rates for Each Influenza Antigen Post-Vaccination | B/Malaysia Split/2506/2004 | 80 Percentage of Participants |
| Influenza Vaccine Primed | Seroconversion Rates for Each Influenza Antigen Post-Vaccination | A/Solomon Islands/3/2006 IVR-145 (H1N1) | 83 Percentage of Participants |
| Influenza Vaccine Primed | Seroconversion Rates for Each Influenza Antigen Post-Vaccination | A/Wisconsin/67/2005 (X-161B) (H3N2) | 67 Percentage of Participants |
| Influenza Vaccine Primed | Seroconversion Rates for Each Influenza Antigen Post-Vaccination | B/Malaysia Split/2506/2004 | 100 Percentage of Participants |