Influenza
Conditions
Keywords
Influenza, Influenza Virus Vaccine, Fluzone®
Brief summary
To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
Interventions
BIOLOGICALInfluenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (infant/children dose)
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 36 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 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | 14 days post-vaccination | GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | 0 to 3 days post-vaccination 1 | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). |
| Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | 0 to 3 days post-vaccination 2 | Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). Note: Influenza vaccine-primed group did not receive vaccination 2 |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 13 October to 13 December 2006, at a single site in the US.
Pre-assignment details
A total of 31 subjects that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Influenza Vaccine-Naive Group Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. | 14 |
| Influenza Vaccine-Primed Group Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0. | 17 |
| Total | 31 |
Baseline characteristics
| Characteristic | Influenza Vaccine-Primed Group | Influenza Vaccine-Naive Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 17 Participants | 14 Participants | 31 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 | 29.3 Months STANDARD_DEVIATION 6.55 | 15.4 Months STANDARD_DEVIATION 7.4 | 23.0 Months STANDARD_DEVIATION 9.82 |
| Region of Enrollment United States | 17 participants | 14 participants | 31 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 14 | 7 / 17 |
| serious Total, serious adverse events | 0 / 14 | 0 / 17 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)
Time frame: 14 days post-vaccination
Population: Geometric mean titers were evaluated in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H1N1 Flu A/New Caledonia/20/99 - Pre | 5.36 Titer |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H1N1 Flu A/New Caledonia/20/99 - Post | 169 Titer |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H3N2 Flu A/Wisconsin/67/2005 - Pre | 13.7 Titer |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H3N2 Flu A/Wisconsin/67/2005 - Post | 806 Titer |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | Flu B/Malaysia Split/2506/2004 - Pre | 5.55 Titer |
| Influenza Vaccine-Naive Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | Flu B/Malaysia Split/2506/2004 - Post | 234 Titer |
| Influenza Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | Flu B/Malaysia Split/2506/2004 - Pre | 6.23 Titer |
| Influenza Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H1N1 Flu A/New Caledonia/20/99 - Pre | 15.1 Titer |
| Influenza Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H3N2 Flu A/Wisconsin/67/2005 - Post | 698 Titer |
| Influenza Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H1N1 Flu A/New Caledonia/20/99 - Post | 135 Titer |
| Influenza Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | Flu B/Malaysia Split/2506/2004 - Post | 54.8 Titer |
| Influenza Vaccine-Primed Group | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination | H3N2 Flu A/Wisconsin/67/2005 - Pre | 22.0 Titer |
Other Pre-specified
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.
Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).
Time frame: 0 to 3 days post-vaccination 1
Population: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Tenderness | 3 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Vomiting (≥ 6 episodes) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Tenderness-reduced movement | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Loss of Appetite | 1 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Pain | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Fever (>103.1°F) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Swelling | 1 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Abnormal Crying | 3 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Headache | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Solicited Systemic Reaction Post-dose 1 | 7 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Malaise | 2 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Fever | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Vomiting (Per 24 hours) | 2 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Abnormal Crying (> 3 hours) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Irritability | 5 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Drowsiness | 1 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Redness | 2 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Headache (Prevented daily activities) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Redness (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Myalgia | 1 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Solicited Injection Site Reaction Post-dose 1 | 3 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Myalgia (Prevented daily activities) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Drowsiness (Sleeping most time) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Malaise (Prevented daily activities) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Headache | 3 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Fever | 1 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Vomiting (Per 24 hours) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Vomiting (≥ 6 episodes) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Abnormal Crying | 2 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Drowsiness | 1 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Drowsiness (Sleeping most time) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Loss of Appetite | 2 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Irritability (Inconsolable) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Malaise | 3 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Malaise (Prevented daily activities) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Pain (Incapacitating) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Redness (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Solicited Injection Site Reaction Post-dose 1 | 6 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Tenderness | 2 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Tenderness-reduced movement | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Pain | 4 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Swelling | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 injection site Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Solicited Systemic Reaction Post-dose 1 | 7 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Fever (>103.1°F) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Abnormal Crying (> 3 hours) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Loss of Appetite (Refuses ≥ 3 feeds) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Irritability | 2 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any injection site Redness | 1 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Headache (Prevented daily activities) | 0 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Any Myalgia | 1 Participants |
| Influenza Vaccine-Primed Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1. | Grade 3 Myalgia (Prevented daily activities) | 0 Participants |
Other Pre-specified
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.
Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia). Note: Influenza vaccine-primed group did not receive vaccination 2
Time frame: 0 to 3 days post-vaccination 2
Population: Safety analysis was on all enrolled and vaccinated participants, intend to treat population.~Influenza vaccine-primed group did not received vaccination 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any solicited injection site reaction Post-dose 2 | 4 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any injection site Tenderness | 4 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 injection site Tenderness-reduced movement | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Vomiting (per 24 hours) | 2 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Vomiting (≥ 6 episodes) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 abnormal Crying (> 3 hours) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Drowsiness | 3 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Drowsiness (sleeping most time) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Loss of appetite | 5 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Loss of appetitie (refuses 3 feeds) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Irritability | 5 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Irritability (inconsolable) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Headache | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Myalgia | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Myalgia (prevents daily activities) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Malaise | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Malaise (prevents daily activities) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any injection site Pain | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 injection site Pain (incapacitating) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any injection site Redness | 3 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 injection site Redness (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any injection site Swelling | 1 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 injection site Swelling (≥ 5.0 cm) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any solicited systemic reaction Post-dose 2 | 6 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any Fever | 1 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Fever (> 103.1ºF) | 0 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Any abnormal Crying | 4 Participants |
| Influenza Vaccine-Naive Group | Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2. | Grade 3 Headache (prevents daily activities) | 0 Participants |