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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00391391
• Collaborator: (none)
• Enrollment: 520
• Locations: 19
• Arms: 4
• Duration (Months): 12
• Patients Per Site: 27.4
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthomyxoviridae Infection; Influenza; Myxovirus Infection	Biological: Split, Inactivated, Trivalent Influenza Vaccine; Biological: Split, Inactivated, Trivalent Influenza Vaccine; Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 520 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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.
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine; Vaccine (infant dose)
Experimental: 2 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine; Vaccine (children dose)
Active Comparator: 3 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Vaccine (infant dose); Other Names: Fluzone® 2006/2007 Formulation.
Active Comparator: 4 Split, Inactivated, Trivalent Influenza Vaccine	Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Vaccine (children dose); Other Names: Fluzone® 2006/2007 Formulation.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 8 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Harrisburg	Arkansas	United States	72432
2		Little Rock	Arkansas	United States	72205
3		Trumann	Arkansas	United States	72472
4		Bellflower	California	United States	90706
5		Downey	California	United States	90241
6		Fountain Valley	California	United States	92708
7		Paramount	California	United States	90723
8		Owensboro	Kentucky	United States	42303
9		Bossier City	Louisiana	United States	71111
10		Shreveport	Louisiana	United States	71105
11		Brainerd	Minnesota	United States	56401
12		Cleveland	Ohio	United States	44121
13		Erie	Pennsylvania	United States	16505
14		Pittsburgh	Pennsylvania	United States	15277
15		Uniontown	Pennsylvania	United States	15401
16		Wexford	Pennsylvania	United States	15090
17		Fort Worth	Texas	United States	76107
18		Salt Lake City	Utah	United States	84109
19		Salt Lake City	Utah	United States	84121

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Medical Director, Sanofi Pasteur Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00391391
• Other Study ID Numbers: FID07
• First Posted: Oct 24, 2006
• Last Update Posted: Dec 1, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Sanofi: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Infants; children.
• Additional relevant MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections; Vaccines

Study Results

Participant Flow

Recruitment Details	Study participants ere enrolled from 19 October to 12 December 2006 in 20 clinical centers in the US.
Pre-assignment Detail	A total of 517 of the 520 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Period Title: Overall Study
STARTED	98	97	161	164
COMPLETED	89	87	138	145
NOT COMPLETED	9	10	23	19

Baseline Characteristics

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age	Total
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine	Total of all reporting groups
Overall Participants	97	97	160	163	517
Age (Count of Participants)
<=18 years	97 100%	97 100%	160 100%	163 100%	517 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	22.6 (7.51)	21.8 (8.03)	69.6 (22.2)	70.8 (21.6)	46.5 (14.835)
Sex: Female, Male (Count of Participants)
Female	45 46.4%	43 44.3%	70 43.8%	84 51.5%	242 46.8%
Male	52 53.6%	54 55.7%	90 56.3%	79 48.5%	275 53.2%
Region of Enrollment (Number) [Number]
United States	97 100%	97 100%	160 100%	163 100%	517 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Measure Participants	69	68	115	120
Serogroup A/H1N1 Pre-vaccination	8.9	9.6	20.5	26.9
Serogroup A/H1N1 Post-vaccination 1	58.5	113.1	100.1	264.2
Serogroup A/H1N1 Post-vaccination 2	138.3	160.0	162.9	390.6
Serogroup A/H3N2 Pre-vaccination	22.4	20.9	222.2	171.0
Serogroup A/H3N2 Post-vaccination 1	341.8	566.9	1012.5	1256.9
Serogroup A/H3N2 Post-vaccination 2	614.8	471.4	1111.0	1344.4
Serogroup B Pre-vaccination	5.3	5.4	8.3	6.8
Serogroup B Post-vaccination 1	7.4	9.7	46.6	28.8
Serogroup B Post-vaccination 2	31.1	18.2	56.4	51.6

2. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Measure Participants	69	68	115	120
Serogroup A/H1N1 Post-vaccination 1	52 53.6%	75 77.3%	65 40.6%	74 45.4%
Serogroup A/H1N1 Post-vaccination 2	91 93.8%	88 90.7%	70 43.8%	78 47.9%
Serogroup A/H3N2 Post-vaccination 1	81 83.5%	80 82.5%	44 27.5%	63 38.7%
Serogroup A/H3N2 Post-vaccination 2	88 90.7%	91 93.8%	50 31.3%	62 38%
Serogroup B Post-vaccination 1	5 5.2%	10 10.3%	44 27.5%	40 24.5%
Serogroup B Post-vaccination 2	44 45.4%	21 21.6%	55 34.4%	53 32.5%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Measure Participants	69	68	115	120
Serogroup A/H1N1 Pre-vaccination	9 9.3%	12 12.4%	33 20.6%	40 24.5%
Serogroup A/H1N1 Post-vaccination 1	52 53.6%	75 77.3%	79 49.4%	95 58.3%
Serogroup A/H1N1 Post-vaccination 2	91 93.8%	93 95.9%	92 57.5%	99 60.7%
Serogroup A/H3N2 Pre-vaccination	32 33%	29 29.9%	86 53.8%	80 49.1%
Serogroup A/H3N2 Post-vaccination 1	85 87.6%	95 97.9%	97 60.6%	100 61.3%
Serogroup A/H3N2 Post-vaccination 2	100 103.1%	100 103.1%	99 61.9%	100 61.3%
Serogroup B Pre-vaccination	2 2.1%	2 2.1%	9 5.6%	3 1.8%
Serogroup B Post-vaccination 1	5 5.2%	10 10.3%	47 29.4%	42 25.8%
Serogroup B Post-vaccination 2	44 45.4%	21 21.6%	63 39.4%	58 35.6%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Measure Participants	69	97	160	120
Serogroup A/H1N1 Post-vaccination 1	52 53.6%	75 77.3%	65 40.6%	74 45.4%
Serogroup A/H1N1 Post-vaccination 2	91 93.8%	88 90.7%	70 43.8%	78 47.9%
Serogroup A/H3N2 Post-vaccination 1	81 83.5%	80 82.5%	44 27.5%	63 38.7%
Serogroup A/H3N2 Post-vaccination 2	88 90.7%	91 93.8%	50 31.3%	62 38%
Serogroup B Post-vaccination 1	5 5.2%	10 10.3%	44 27.5%	40 24.5%
Serogroup B Post-vaccination 2	44 45.4%	21 21.6%	55 34.4%	53 32.5%

5. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Measure Participants	97	97	0	0
Any injection site tenderness Injection 1	51 52.6%	43 44.3%
Grade 3 Tenderness (Reduced movement)	0 0%	0 0%
Any Injection site redness Injection 1	48 49.5%	27 27.8%
Grade 3 redness ( ≥ 5 cm)	0 0%	0 0%
Any Injection site swelling Injection 1	23 23.7%	15 15.5%
Grade 3 swelling ( ≥ 5 cm)	0 0%	0 0%
Any Injection site induration Injection 1	24 24.7%	13 13.4%
Grade 3 induration ( ≥ 5 cm)	0 0%	0 0%
Any Injection site ecchymosis Injection 1	12 12.4%	13 13.4%
Grade 3 ecchymosis ( ≥ 5 cm)	1 1%	0 0%
Any injection site tenderness Injection 2	48 49.5%	49 50.5%
Grade 3 Tenderness (Reduced movement)	1 1%	1 1%
Any Injection site redness Injection 2	48 49.5%	28 28.9%
Grade 3 redness ( ≥ 5 cm)	1 1%	0 0%
Any Injection site swelling Injection 2	18 18.6%	13 13.4%
Grade 3 swelling ( ≥ 5 cm)	1 1%	0 0%
Any Injection site induration Injection 2	18 18.6%	14 14.4%
Grade 3 induration ( ≥ 5 cm)	0 0%	0 0%
Any Injection site ecchymosis Injection 2	23 23.7%	13 13.4%
Grade 3 ecchymosis ( ≥ 5 cm)	1 1%	0 0%
Any Solicited Fever Injection 1	10 10.3%	10 10.3%
Grade 3 Fever > 103.1°F	1 1%	0 0%
Any Solicited Vomiting Injection 1	5 5.2%	6 6.2%
Grade 3 Vomiting ≥ 6 episodes per 24 hours	0 0%	0 0%
Any Solicited Crying Abnormal Injection 1	17 17.5%	29 29.9%
Grade 3 Crying Abnormal >3 hours	3 3.1%	0 0%
Any Solicited Drowsiness Injection 1	21 21.6%	24 24.7%
Grade 3 Drowsiness Sleeping most of the time	3 3.1%	0 0%
Any Solicited Appetite Lost Injection 1	20 20.6%	21 21.6%
Grade 3 Appetite Lost refuses most feeds	3 3.1%	0 0%
Any Solicited Irritability Injection 1	37 38.1%	39 40.2%
Grade 3 Irritability inconsolable	2 2.1%	1 1%
Any Solicited Fever Injection 2	6 6.2%	9 9.3%
Grade 3 Fever > 103.1°F	0 0%	1 1%
Any Solicited Vomiting Injection 2	4 4.1%	7 7.2%
Grade 3 Vomiting ≥ 6 episodes per 24 hours	0 0%	0 0%
Any Solicited Crying Abnormal Injection 2	19 19.6%	16 16.5%
Grade 3 Crying Abnormal >3 hours	1 1%	2 2.1%
Any Solicited Drowsiness Injection 2	13 13.4%	23 23.7%
Grade 3 Drowsiness Sleeping most of the time	0 0%	0 0%
Any Solicited Appetite Lost Injection 2	18 18.6%	17 17.5%
Grade 3 Appetite Lost refuses most feeds	1 1%	1 1%
Any Solicited Irritability Injection 2	30 30.9%	30 30.9%
Grade 3 Irritability inconsolable	3 3.1%	4 4.1%

6. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months	Group 2: Fluzone IM 6 to 35 Months Age Group	Group 3: Fluzone ID at 3 to 8 Years Age	Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine	Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine	Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine	Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Measure Participants	0	0	160	163
Any injection site Pain Injection 1	93 95.9%	89 91.8%
Grade 3 Pain (Reduced movement)	0 0%	0 0%
Any Injection site Redness Injection 1	98 101%	42 43.3%
Grade 3 Redness ( ≥ 5 cm)	2 2.1%	1 1%
Any Injection site Swelling Injection 1	59 60.8%	30 30.9%
Grade 3 Swelling ( ≥ 5 cm)	1 1%	0 0%
Any Injection site Induration Injection 1	56 57.7%	25 25.8%
Grade 3 Induration ( ≥ 5 cm)	1 1%	0 0%
Any Injection site Ecchymosis Injection 1	18 18.6%	19 19.6%
Grade 3 Ecchymosis ( ≥ 5 cm)	0 0%	1 1%
Any Solicited Pruritus Injection 1	23 23.7%	11 11.3%
Any injection site pain Injection 2	98 101%	90 92.8%
Grade 3 Pain (Reduced movement)	0 0%	1 1%
Any Injection site Redness Injection 2	94 96.9%	40 41.2%
Grade 3 Redness (≥ 5 cm)	1 1%	1 1%
Any Injection site Swelling Injection 2	61 62.9%	21 21.6%
Grade 3 swelling ( ≥ 5 cm)	1 1%	0 0%
Any Injection site Induration Injection 2	50 51.5%	17 17.5%
Grade 3 Induration (≥ 5 cm)	1 1%	0 0%
Any Injection site Ecchymosis Injection 2	18 18.6%	22 22.7%
Grade 3 Ecchymosis (≥ 5 cm)	0 0%	0 0%
Any Solicited Pruritus Injection 2	15 15.5%	19 19.6%
Any Solicited Fever Injection 1	10 10.3%	18 18.6%
Grade 3 Fever > 102.2°F	2 2.1%	3 3.1%
Any Solicited Headache Injection 1	22 22.7%	25 25.8%
Grade 3 Headache Prevents daily activities	1 1%	1 1%
Any Solicited Malaise Injection 1	21 21.6%	30 30.9%
Grade 3 Malaise Prevents daily activities	1 1%	2 2.1%
Any Solicited Myalgia Injection 1	24 24.7%	42 43.3%
Grade 3 Myalgia Prevents daily activities	0 0%	0 0%
Any Solicited Fever Injection 2	16 16.5%	14 14.4%
Grade 3 Fever > 102.2°F	0 0%	2 2.1%
Any Solicited Headache Injection 2	15 15.5%	17 17.5%
Grade 3 Headache Prevents daily activities	2 2.1%	2 2.1%
Any Solicited Malaise Injection 2	24 24.7%	21 21.6%
Grade 3 Malaise Prevents daily activities	1 1%	1 1%
Any Solicited Myalgia Injection 2	24 24.7%	25 25.8%
Grade 3 Myalgia Prevents daily activities	2 2.1%	0 0%

Adverse Events

Time Frame	Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
Arm/Group Title	Group 1: Fluzone ID at Age 6 to 35 Months		Group 2: Fluzone IM 6 to 35 Months Age Group		Group 3: Fluzone ID at 3 to 8 Years Age		Group 4: Fluzone IM 3 to 8 Years Age
Arm/Group Description	Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine		Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine		Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine		Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
All Cause Mortality
	Group 1: Fluzone ID at Age 6 to 35 Months		Group 2: Fluzone IM 6 to 35 Months Age Group		Group 3: Fluzone ID at 3 to 8 Years Age		Group 4: Fluzone IM 3 to 8 Years Age
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: Fluzone ID at Age 6 to 35 Months		Group 2: Fluzone IM 6 to 35 Months Age Group		Group 3: Fluzone ID at 3 to 8 Years Age		Group 4: Fluzone IM 3 to 8 Years Age
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/97 (1%)		1/97 (1%)		1/160 (0.6%)		1/163 (0.6%)
Infections and infestations
Gastroenteritis viral	0/97 (0%)	0	1/97 (1%)	1	0/160 (0%)	0	0/163 (0%)	0
Viral infection	0/97 (0%)	0	0/97 (0%)	0	1/160 (0.6%)	1	0/163 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/97 (1%)	1	0/97 (0%)	0	0/160 (0%)	0	0/163 (0%)	0
Nervous system disorders
Autism	0/97 (0%)	0	0/97 (0%)	0	0/160 (0%)	0	1/163 (0.6%)	1
Other (Not Including Serious) Adverse Events
	Group 1: Fluzone ID at Age 6 to 35 Months		Group 2: Fluzone IM 6 to 35 Months Age Group		Group 3: Fluzone ID at 3 to 8 Years Age		Group 4: Fluzone IM 3 to 8 Years Age
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/97 (52.6%)		49/97 (50.5%)		98/160 (61.3%)		90/163 (55.2%)
Eye disorders
Conjunctivitis	5/97 (5.2%)	5	6/97 (6.2%)	6	0/160 (0%)	0	0/163 (0%)	0
Gastrointestinal disorders
Diarrhoea	7/97 (7.2%)	8	9/97 (9.3%)	9	15/160 (9.4%)	15	3/163 (1.8%)	3
Teething	7/97 (7.2%)	8	6/97 (6.2%)	11	0/160 (0%)	0	0/163 (0%)	0
Vomiting	3/97 (3.1%)	3	6/97 (6.2%)	6	14/160 (8.8%)	14	12/163 (7.4%)	13
Vomiting	5/93 (5.4%)	5	7/86 (8.1%)	7	0/160 (0%)	7	0/163 (0%)	7
Appetite lost	20/93 (21.5%)	20	21/91 (23.1%)	21	0/160 (0%)	21	0/163 (0%)	21
General disorders
Pyrexia	8/97 (8.2%)	9	22/97 (22.7%)	27	13/160 (8.1%)	13	14/163 (8.6%)	14
Vessel puncture site bruise	11/97 (11.3%)	12	15/97 (15.5%)	17	11/160 (6.9%)	11	16/163 (9.8%)	19
Injection site Tenderness	51/93 (54.8%)	51	49/87 (56.3%)	49	98/137 (71.5%)	98	90/145 (62.1%)	90
Injection site Redness	48/93 (51.6%)	48	28/87 (32.2%)	28	98/143 (68.5%)	98	42/151 (27.8%)	42
Injection site Swelling	23/88 (26.1%)	23	15/90 (16.7%)	15	61/137 (44.5%)	61	30/151 (19.9%)	30
Injection site Induration	24/93 (25.8%)	24	14/87 (16.1%)	14	56/143 (39.2%)	56	25/151 (16.6%)	25
Injection site Ecchymosis	23/88 (26.1%)	23	13/87 (14.9%)	13	18/143 (12.6%)	18	22/145 (15.2%)	22
Malaise	0/97 (0%)		0/97 (0%)		24/136 (17.6%)	24	30/150 (20%)	30
Myalgia	0/97 (0%)		0/97 (0%)		24/141 (17%)	24	42/150 (28%)	42
Infections and infestations
Bronchitis	0/97 (0%)	0	5/97 (5.2%)	5	0/160 (0%)	0	0/163 (0%)	0
Croup infections	4/97 (4.1%)	4	5/97 (5.2%)	5	4/160 (2.5%)	4	3/163 (1.8%)	4
Gastroenteritis	5/97 (5.2%)	5	0/97 (0%)	0	4/160 (2.5%)	4	2/163 (1.2%)	2
Nasopharyngitis	14/97 (14.4%)	16	9/97 (9.3%)	11	4/160 (2.5%)	5	18/163 (11%)	20
Otitis media	17/97 (17.5%)	19	23/97 (23.7%)	27	8/160 (5%)	9	8/163 (4.9%)	8
Sinusitis	4/97 (4.1%)	4	7/97 (7.2%)	7	5/160 (3.1%)	5	4/163 (2.5%)	4
Upper respiratory tract infection	15/97 (15.5%)	17	18/97 (18.6%)	23	9/160 (5.6%)	10	7/163 (4.3%)	10
Viral infection	2/97 (2.1%)	2	5/97 (5.2%)	5	5/160 (3.1%)	5	0/163 (0%)	0
Nervous system disorders
Drowsiness	21/93 (22.6%)	21	24/91 (26.4%)	24	0/160 (0%)	24	0/163 (0%)	24
Irritability	37/93 (39.8%)	37	39/91 (42.9%)	39	0/160 (0%)	39	0/163 (0%)	39
Headache	0/97 (0%)		0/97 (0%)		22/141 (15.6%)	22	25/150 (16.7%)	25
Psychiatric disorders
Crying abnormal	17/93 (18.3%)	17	29/91 (31.9%)	29	0/160 (0%)	29	0/163 (0%)	29
Respiratory, thoracic and mediastinal disorders
Cough	33/97 (34%)	44	32/97 (33%)	39	46/160 (28.8%)	60	42/163 (25.8%)	55
Nasal congestion	7/97 (7.2%)	11	4/97 (4.1%)	6	4/160 (2.5%)	5	9/163 (5.5%)	11
Pharyngolaryngeal pain	0/97 (0%)	0	2/97 (2.1%)	2	7/160 (4.4%)	8	12/163 (7.4%)	15
Rhinorrhoea	18/97 (18.6%)	24	19/97 (19.6%)	26	19/160 (11.9%)	30	20/163 (12.3%)	26
Skin and subcutaneous tissue disorders
Pruritus	0/97 (0%)		0/97 (0%)		23/139 (16.5%)	23	19/144 (13.2%)	19

Limitations/Caveats

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Principal Investigators are NOT employed by the organization sponsoring the study.

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