Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00391391

Enrollment

520

Registered

2006-10-24

Start date

2006-10-31

Completion date

2007-10-31

Last updated

2011-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Myxovirus Infection, Orthomyxoviridae Infection

Keywords

Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Infants, children.

Brief summary

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Interventions

BIOLOGICALSplit, Inactivated, Trivalent Influenza Vaccine

Vaccine (infant dose)

BIOLOGICALSplit, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Vaccine (infant dose)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 8 Years

Healthy volunteers

Yes

Inclusion criteria

: * Aged 6 months to 8 years but not yet 9 years on the day of inclusion. * Subject is healthy, as determined by medical history. * Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations). * Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

Exclusion criteria

: * Participation in another clinical trial in the 4 weeks preceding the trial vaccination. * Planned participation in another clinical trial during the present trial period. * Personal or family history of Guillain-Barré Syndrome. * Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy 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. * Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion * Received blood or blood-derived products in the previous 3 months. * Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw). * Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity. * Known thrombocytopenia or bleeding disorder contraindicating IM vaccination. * Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment. * History of seizures. * Received antibiotics therapy within 72 hours preceding the trial vaccination. * Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination. * Any condition, which in the opinion of the investigator would pose a health risk to the participant.

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 0 and Day 28 post-vaccination	Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Secondary

Measure	Time frame	Description
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 28 post-vaccination	Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 28 post-vaccination	Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 28 post-vaccination	Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer \< 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Day 0 to Day 7 post-vaccination	Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Day 0 to Day 7 post-vaccination	Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.

Countries

United States

Participant flow

Recruitment details

Study participants ere enrolled from 19 October to 12 December 2006 in 20 clinical centers in the US.

Pre-assignment details

A total of 517 of the 520 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participants by arm

Arm	Count
Group 1: Fluzone ID at Age 6 to 35 Months Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	97
Group 2: Fluzone IM 6 to 35 Months Age Group Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	97
Group 3: Fluzone ID at 3 to 8 Years Age Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	160
Group 4: Fluzone IM 3 to 8 Years Age Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine	163
Total	517

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	0	0	0	1
Overall Study	Lost to Follow-up	1	3	7	4
Overall Study	Protocol Violation	2	3	6	7
Overall Study	Withdrawal by Subject	6	4	10	7

Baseline characteristics

Characteristic	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 1: Fluzone ID at Age 6 to 35 Months	Group 4: Fluzone IM 3 to 8 Years Age	Total
Age, Categorical <=18 years	97 Participants	160 Participants	97 Participants	163 Participants	517 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age Continuous	21.8 Months STANDARD_DEVIATION 8.03	69.6 Months STANDARD_DEVIATION 22.2	22.6 Months STANDARD_DEVIATION 7.51	70.8 Months STANDARD_DEVIATION 21.6	46.5 Months STANDARD_DEVIATION 14.835
Region of Enrollment United States	97 Participants	160 Participants	97 Participants	163 Participants	517 Participants
Sex: Female, Male Female	43 Participants	70 Participants	45 Participants	84 Participants	242 Participants
Sex: Female, Male Male	54 Participants	90 Participants	52 Participants	79 Participants	275 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	51 / 97	49 / 97	98 / 160	90 / 163
serious Total, serious adverse events	1 / 97	1 / 97	1 / 160	1 / 163

Outcome results

Primary

Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Time frame: Day 0 and Day 28 post-vaccination

Population: Geometric Mean Titers were determined in the per-protocol population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	5.3 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	614.8 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	31.1 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	22.4 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	138.3 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	58.5 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	7.4 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	341.8 Titers
Group 1: Fluzone ID at Age 6 to 35 Months	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	8.9 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	566.9 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	5.4 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	471.4 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	113.1 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	9.6 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	160.0 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	18.2 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	9.7 Titers
Group 2: Fluzone IM 6 to 35 Months Age Group	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	20.9 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	1012.5 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	20.5 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	100.1 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	162.9 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	222.2 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	1111.0 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	8.3 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	46.6 Titers
Group 3: Fluzone ID at 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	56.4 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	6.8 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	171.0 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	390.6 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	51.6 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	28.8 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	264.2 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	1344.4 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	1256.9 Titers
Group 4: Fluzone IM 3 to 8 Years Age	Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	26.9 Titers

Secondary

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds

Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.

Time frame: Day 0 to Day 7 post-vaccination

Population: Safety parameters were determined post-vaccination in the safety, intend-to-treat population.

Arm	Measure	Group	Value (NUMBER)
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Ecchymosis Injection 2	18 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Pruritus Injection 1	23 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Ecchymosis (≥ 5 cm)	0 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Redness ( ≥ 5 cm)	2 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Pruritus Injection 2	15 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any injection site pain Injection 2	98 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Fever Injection 1	10 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Induration Injection 1	56 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Fever > 102.2°F	2 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Pain (Reduced movement)	0 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Headache Injection 1	22 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Redness Injection 1	98 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Headache Prevents daily activities	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Redness Injection 2	94 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Malaise Injection 1	21 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Induration ( ≥ 5 cm)	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Malaise Prevents daily activities	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Redness (≥ 5 cm)	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Myalgia Injection 1	24 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Swelling Injection 1	59 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Myalgia Prevents daily activities	0 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Swelling Injection 2	61 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Fever Injection 2	16 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Ecchymosis Injection 1	18 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Fever > 102.2°F	0 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 swelling ( ≥ 5 cm)	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Headache Injection 2	15 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Pain (Reduced movement)	0 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Headache Prevents daily activities	2 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Induration Injection 2	50 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Malaise Injection 2	24 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Ecchymosis ( ≥ 5 cm)	0 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Malaise Prevents daily activities	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Induration (≥ 5 cm)	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Myalgia Injection 2	24 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Swelling ( ≥ 5 cm)	1 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Myalgia Prevents daily activities	2 Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any injection site Pain Injection 1	93 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Myalgia Prevents daily activities	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any injection site Pain Injection 1	89 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Pain (Reduced movement)	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Redness Injection 1	42 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Redness ( ≥ 5 cm)	1 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Swelling Injection 1	30 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Swelling ( ≥ 5 cm)	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Induration Injection 1	25 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Induration ( ≥ 5 cm)	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Ecchymosis Injection 1	19 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Ecchymosis ( ≥ 5 cm)	1 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Pruritus Injection 1	11 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any injection site pain Injection 2	90 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Pain (Reduced movement)	1 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Redness Injection 2	40 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Redness (≥ 5 cm)	1 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Swelling Injection 2	21 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 swelling ( ≥ 5 cm)	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Induration Injection 2	17 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Induration (≥ 5 cm)	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Injection site Ecchymosis Injection 2	22 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Ecchymosis (≥ 5 cm)	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Pruritus Injection 2	19 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Fever Injection 1	18 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Fever > 102.2°F	3 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Headache Injection 1	25 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Headache Prevents daily activities	1 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Malaise Injection 1	30 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Malaise Prevents daily activities	2 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Myalgia Injection 1	42 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Myalgia Prevents daily activities	0 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Fever Injection 2	14 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Fever > 102.2°F	2 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Headache Injection 2	17 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Headache Prevents daily activities	2 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Malaise Injection 2	21 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Grade 3 Malaise Prevents daily activities	1 Participants
Group 4: Fluzone IM 3 to 8 Years Age	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Any Solicited Myalgia Injection 2	25 Participants

Secondary

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.

Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.

Time frame: Day 0 to Day 7 post-vaccination

Population: Safety parameters were determined post-vaccination in the safety, intend-to-treat population.

Arm	Measure	Group	Value (NUMBER)
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Vomiting Injection 1	5 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site induration Injection 1	24 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Vomiting ≥ 6 episodes per 24 hours	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site redness Injection 2	48 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Crying Abnormal Injection 1	17 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site redness Injection 1	48 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Crying Abnormal >3 hours	3 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 redness ( ≥ 5 cm)	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Drowsiness Injection 1	21 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 induration ( ≥ 5 cm)	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Drowsiness Sleeping most of the time	3 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site swelling Injection 2	18 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Appetite Lost Injection 1	20 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site swelling Injection 1	23 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Appetite Lost refuses most feeds	3 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 swelling ( ≥ 5 cm)	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Irritability Injection 1	37 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site ecchymosis Injection 1	12 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Irritability inconsolable	2 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site induration Injection 2	18 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Fever Injection 2	6 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Tenderness (Reduced movement)	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Fever > 103.1°F	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 induration ( ≥ 5 cm)	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Vomiting Injection 2	4 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 ecchymosis ( ≥ 5 cm)	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Vomiting ≥ 6 episodes per 24 hours	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site ecchymosis Injection 2	23 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Crying Abnormal Injection 2	19 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 swelling ( ≥ 5 cm)	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Crying Abnormal >3 hours	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 ecchymosis ( ≥ 5 cm)	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Drowsiness Injection 2	13 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any injection site tenderness Injection 2	48 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Drowsiness Sleeping most of the time	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Fever Injection 1	10 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Appetite Lost Injection 2	18 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 redness ( ≥ 5 cm)	0 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Appetite Lost refuses most feeds	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Fever > 103.1°F	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Irritability Injection 2	30 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Tenderness (Reduced movement)	1 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Irritability inconsolable	3 Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any injection site tenderness Injection 1	51 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Irritability inconsolable	4 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any injection site tenderness Injection 1	43 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Tenderness (Reduced movement)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site redness Injection 1	27 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 redness ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site swelling Injection 1	15 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 swelling ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site induration Injection 1	13 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 induration ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site ecchymosis Injection 1	13 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 ecchymosis ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any injection site tenderness Injection 2	49 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Tenderness (Reduced movement)	1 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site redness Injection 2	28 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 redness ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site swelling Injection 2	13 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 swelling ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site induration Injection 2	14 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 induration ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Injection site ecchymosis Injection 2	13 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 ecchymosis ( ≥ 5 cm)	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Fever Injection 1	10 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Fever > 103.1°F	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Vomiting Injection 1	6 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Vomiting ≥ 6 episodes per 24 hours	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Crying Abnormal Injection 1	29 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Crying Abnormal >3 hours	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Drowsiness Injection 1	24 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Drowsiness Sleeping most of the time	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Appetite Lost Injection 1	21 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Appetite Lost refuses most feeds	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Irritability Injection 1	39 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Irritability inconsolable	1 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Fever Injection 2	9 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Fever > 103.1°F	1 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Vomiting Injection 2	7 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Vomiting ≥ 6 episodes per 24 hours	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Crying Abnormal Injection 2	16 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Crying Abnormal >3 hours	2 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Drowsiness Injection 2	23 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Drowsiness Sleeping most of the time	0 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Appetite Lost Injection 2	17 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Grade 3 Appetite Lost refuses most feeds	1 Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Any Solicited Irritability Injection 2	30 Participants

Secondary

Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Time frame: Day 28 post-vaccination

Population: 4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population

Arm	Measure	Group	Value (NUMBER)
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	52 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	91 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	81 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	88 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	5 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	44 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	21 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	91 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	75 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	80 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	88 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	10 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	70 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	44 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	50 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	55 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	44 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	65 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	40 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	53 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	78 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	62 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	74 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	63 Percentage of Participants

Secondary

Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer \< 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.

Time frame: Day 28 post-vaccination

Population: Seroconversion to vaccine antigens were determined in the per-protocol population

Arm	Measure	Group	Value (NUMBER)
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	52 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	91 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	81 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	88 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	5 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	44 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	21 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	91 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	75 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	80 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	88 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	10 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	70 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	44 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	50 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	55 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	44 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	65 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	40 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	53 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	78 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	62 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	74 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	63 Percentage of Participants

Secondary

Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Seroprotection was defined as participants achieving a post-dose antibody titers ≥40. Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Time frame: Day 28 post-vaccination

Population: Seroprotection to vaccine antigens were determined in the per-protocol population

Arm	Measure	Group	Value (NUMBER)
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	85 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	91 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	44 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	32 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	5 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	2 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	52 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	9 Percentage of Participants
Group 1: Fluzone ID at Age 6 to 35 Months	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	100 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	21 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	12 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	75 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	93 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	29 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	95 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	100 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	2 Percentage of Participants
Group 2: Fluzone IM 6 to 35 Months Age Group	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	10 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	97 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	9 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	99 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	33 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	47 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	92 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	63 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	86 Percentage of Participants
Group 3: Fluzone ID at 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	79 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Pre-vaccination	80 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 1	100 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 1	42 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H3N2 Post-vaccination 2	100 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Pre-vaccination	40 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Post-vaccination 2	58 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup B Pre-vaccination	3 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 2	99 Percentage of Participants
Group 4: Fluzone IM 3 to 8 Years Age	Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Serogroup A/H1N1 Post-vaccination 1	95 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

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Outcome results

Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds

Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.

Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine