Influenza
Conditions
Keywords
Fluzone®, Influenza, Influenza virus infection, Influenza vaccine
Brief summary
To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).
Interventions
BIOLOGICALInfluenza Virus Vaccine, Fluzone®
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
11 Months to 14 Months
Healthy volunteers
Yes
Inclusion criteria
: * Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot. * Considered to be in good health on the basis of reported medical history and history-directed physical evaluation. * Available for the duration of the study. * Parent/legal representative willing and able to provide informed consent. * Parent/legal representative able to attend all scheduled visits and comply with all trial procedures. * Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.
Exclusion criteria
: * Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.) * Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine. * Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza. * An acute illness with fever (rectal temperature ≥ 100.4°F \[38.0°C\]) in the 72 hours preceding enrollment in the trial (defer enrollment). * Known bleeding disorder. * Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior 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 that, in the opinion of the investigator, could interfere with trial conduct or completion. * Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother. * Known HIV, Hepatitis B, or Hepatitis C infection. * Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * Prior personal history of Guillain-Barré syndrome. * Any condition that, 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 Seroprotected Participants Post-vaccination With Fluzone® | Day 28 Post-vaccination | Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Day 28 Post-vaccination | Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Days 0-7 Post-vaccination | Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled into this study from 03 October 2006 to 04 January 2007 at 5 US clinical centers.
Pre-assignment details
A total of 173 participants were enrolled, vaccinated, and analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone®-Primed Group Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. | 116 |
| Fluzone®-Naive Group Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation. | 57 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Fluzone®-Naive Group | Fluzone®-Primed Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 116 Participants | 173 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 | 13.9 Months STANDARD_DEVIATION 1.13 | 13.8 Months STANDARD_DEVIATION 1.01 | 13.8 Months STANDARD_DEVIATION 1.07 |
| Region of Enrollment United States | 57 participants | 116 participants | 173 participants |
| Sex: Female, Male Female | 22 Participants | 48 Participants | 70 Participants |
| Sex: Female, Male Male | 35 Participants | 68 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 87 / 116 | 40 / 57 |
| serious Total, serious adverse events | 1 / 116 | 0 / 57 |
Outcome results
Primary
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
Time frame: Day 28 Post-vaccination
Population: Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone®-Primed Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 1 | 95 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 2 | 79 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2 | 62 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1 | 59 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 2 | 50 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 1 | 10 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 2 | 65 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2 | 82 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1 | 34 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 1 | 6 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 2 | 94 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Seroprotected Participants Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post -Dose 1 | 80 Percentage of Participants |
Secondary
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Time frame: Day 28 Post-vaccination
Population: The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone®-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1 | 41.3 Titers |
| Fluzone®-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 1 | 144 Titers |
| Fluzone®-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 1 | 11.1 Titers |
| Fluzone®-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2 | 42.1 Titers |
| Fluzone®-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 2 | 103 Titers |
| Fluzone®-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 2 | 39.2 Titers |
| Fluzone®-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 2 | 217 Titers |
| Fluzone®-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 1 | 22.7 Titers |
| Fluzone®-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/New Caledonia/20/99 (H1N1) Post-Dose 2 | 78.4 Titers |
| Fluzone®-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu A/Wisconsin/67/2005 (H3N2) Post-Dose 1 | 89.4 Titers |
| Fluzone®-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 2 | 63.9 Titers |
| Fluzone®-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® | Flu B/Malaysia/2506/2004 Post-Dose 1 | 9.27 Titers |
Other Pre-specified
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination
Time frame: Days 0-7 Post-vaccination
Population: The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Drowsiness (Slept most of time) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Abnormal Crying | 42 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Drowsiness (Slept most of time) | 1 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Loss of Appetite | 32 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 5 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Irritability | 57 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Fever (≥ 103.2 ºF) | 2 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Vomiting | 21 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 2 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Abnormal Crying | 55 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Abnormal Crying (> 3 hours) | 3 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Drowsiness | 46 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Drowsiness (Slept most of time) | 1 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Loss of Appetite | 53 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 5 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Irritability | 74 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Irritability (Inconsolable) | 5 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Injection Site Reaction Post-Dose 1 | 51 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Tenderness | 46 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Redness (> 0.5 cm) | 7 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Swelling (> 0.5 cm) | 5 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Injection Site Reaction Post-Dose 2 | 57 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Tenderness | 56 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Tenderness (Crying when limb is moved) | 1 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Redness (> 0.5 cm) | 7 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Swelling (> 0.5 cm) | 4 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Injection Site Reaction - Any Dose | 68 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Tenderness | 65 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Tenderness (Crying when limb is moved) | 1 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Redness (> 0.5 cm) | 13 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Swelling (> 0.5 cm) | 6 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 2 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Systemic Reaction Post-Dose 1 | 75 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Fever | 16 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Fever (≥ 103.2 ºF) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Vomiting | 13 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Abnormal Crying (> 3 hours) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Drowsiness | 32 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Tenderness (Crying when limb is moved) | 0 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Loss of Appetite | 38 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Irritability | 66 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Irritability (Inconsolable) | 2 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Systemic Reaction Post-Dose 2 | 72 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Fever | 17 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Fever (≥ 103.2 ºF) | 2 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Vomiting | 12 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 2 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Abnormal Crying | 39 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Abnormal Crying (> 3 hours) | 3 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Drowsiness | 32 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Irritability (Inconsolable) | 4 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Systemic Reaction - Any Dose | 88 Percentage of Participants |
| Fluzone®-Primed Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Fever | 29 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Drowsiness (Slept most of time) | 2 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Tenderness (Crying when limb is moved) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Swelling (> 0.5 cm) | 7 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Vomiting | 16 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Injection Site Reaction - Any Dose | 69 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Drowsiness | 33 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Irritability | 60 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Drowsiness (Slept most of time) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Tenderness | 69 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Loss of Appetite | 33 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Loss of Appetite | 33 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Tenderness (Crying when limb is moved) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Fever | 24 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 2 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Fever (≥ 103.2 ºF) | 2 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Redness (> 0.5 cm) | 11 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Vomiting | 29 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Abnormal Crying | 53 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Irritability | 64 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Abnormal Crying (> 3 hours) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Swelling (> 0.5 cm) | 7 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Drowsiness | 47 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Systemic Reaction - Any Dose | 89 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Drowsiness (Slept most of time) | 2 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Irritability (Inconsolable) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 2 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Abnormal Crying | 33 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Irritability | 78 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Systemic Reaction Post-Dose 1 | 76 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Irritability (Inconsolable) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Systemic Reaction Post-Dose 2 | 71 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Injection Site Reaction Post-Dose 1 | 55 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Fever | 11 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Tenderness | 55 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Irritability (Inconsolable) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Redness (> 0.5 cm) | 7 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Fever (≥ 103.2 ºF) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Fever | 15 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Abnormal Crying (> 3 hours) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Injection Site Reaction Post-Dose 2 | 51 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Abnormal Crying | 36 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Tenderness | 49 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Fever (≥ 103.2 ºF) | 2 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Tenderness (Crying when limb is moved) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Abnormal Crying (> 3 hours) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Redness (> 0.5 cm) | 6 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Loss of Appetite | 51 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Drowsiness | 31 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Swelling (> 0.5 cm) | 0 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Any Vomiting | 16 Percentage of Participants |
| Fluzone®-Naive Group | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |