Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

• Sponsor: Sanofi Pasteur, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00755274
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

Primary Objective:

To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Observational Objectives:

To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age.

To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.

Condition or Disease	Intervention/Treatment	Phase
Influenza; Orthomyxoviridae Infections	Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose; Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose	Phase 4

Detailed Description

The Advisory Committee on Immunization Practices (ACIP) has in recent years recommended that all healthy children aged 6 through 59 months receive influenza vaccine. Because of the growing emphasis on influenza immunization of infants and young children, Center for Biologics Evaluation and Research (CBER) has expressed interest in receiving sera from children who have been vaccinated with the current formulation of Fluzone® vaccine. These sera will be tested to evaluate each individual's immune response to the current formulation of Fluzone® vaccine and will also be used to evaluate circulating influenza strains in order to support formulation recommendations for the subsequent year (particularly for influenza B strains, which predominantly affect the young).

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2008-2009 Formulation)
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Primed Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1	Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose; 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months); Other Names: Fluzone®
Experimental: Group 2: Naive/Inadequately Primed Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1	Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose; 0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months); Other Names: Fluzone®

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 [Day 0 to Day 3 post-vaccination 1]

   Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.

2. Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2 [Day 0 to Day 3 post-vaccination 2]

   Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.

Other Outcome Measures

1. Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination [Day 28 post-single dose or Day 21 post-Dose 2]

2. Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) [Day 28 post-single dose or Day 21 post-Dose 2]

   Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.

3. Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection) [Day 28 post-single dose or Day 21 post-Dose 2]

   Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.

4. Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) [Day 28 post-single dose or Day 21 post-Dose 2]

   Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.

5. Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion) [Day 28 post-single dose or Day 21 post-Dose 2]

   Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participant is ≥ 6 months to < 5 years of age.

• Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.

• Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.

• Parent/legal acceptable representative is willing and able to provide informed consent.

• Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria:

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.

• History of severe adverse event to any influenza vaccine.

• Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.

• Any vaccination scheduled between Visit 1 and Visit 2.

• Planned participation in any other interventional clinical trial during participation in the study.

• Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.

• Personal or immediate family history of congenital immune deficiency.

• Developmental delay, neurologic disorder, or seizure disorder.

• Chronic medical, congenital, or developmental disorder.

• Known Human immunodeficiency virus (HIV)-positive mother.

• Prior personal history of Guillain-Barré syndrome.

• Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Norfolk	Virginia	United States	23510

Sponsors and Collaborators

• Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director, Sanofi pasteur Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00755274
• Other Study ID Numbers: GRC40
• First Posted: Sep 18, 2008
• Last Update Posted: Apr 14, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Sanofi Pasteur, a Sanofi Company: Influenza; Orthomyxoviruses; Orthomyxoviridae Infections; Influenza vaccine
• Additional relevant MeSH terms: Influenza, Human; Orthomyxoviridae Infections; Vaccines

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 15 September to 1 October 2008 in 1 clinical center in the US.
Pre-assignment Detail	A total of 32 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Period Title: Overall Study
STARTED	24	8
COMPLETED	24	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group	Total
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.	Total of all reporting groups
Overall Participants	24	8	32
Age (Count of Participants)
<=18 years	24 100%	8 100%	32 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	32.8 (10.52)	22.1 (10.36)	30.1 (11.34)
Sex: Female, Male (Count of Participants)
Female	13 54.2%	4 50%	17 53.1%
Male	11 45.8%	4 50%	15 46.9%
Region of Enrollment (participants) [Number]
United States	24 100%	8 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Description	Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Time Frame	Day 0 to Day 3 post-vaccination 1

Outcome Measure Data

Analysis Population Description

Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	24	8
Any Solicited Injection Site Reaction	10 41.7%	2 25%
Any Tenderness	2 8.3%	1 12.5%
Grade 3 Tenderness (Cries When Limb Is Moved)	0 0%	0 0%
Any Pain	8 33.3%	1 12.5%
Grade 3 Pain (Incapacitating)	0 0%	0 0%
Any Erythema	0 0%	2 25%
Grade 3 Erythema (≥ 5 cm)	0 0%	0 0%
Any Swelling	1 4.2%	1 12.5%
Grade 3 Swelling (≥ 5 cm)	0 0%	0 0%
Any Solicited Systemic Reaction	12 50%	4 50%
Any Fever	2 8.3%	2 25%
Grade 3 Fever (> 103.1 ºF)	0 0%	0 0%
Any Vomiting	0 0%	1 12.5%
Grade 3 Vomiting (≥ 6 Episodes per 24 hours)	0 0%	0 0%
Any Crying Abnormal	0 0%	0 0%
Grade 3 Crying Abnormal (> 3 hours)	0 0%	0 0%
Any Drowsiness	4 16.7%	0 0%
Grade 3 Drowsiness (Sleeps most of time)	0 0%	0 0%
Any Appetite Lost	1 4.2%	0 0%
Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds)	0 0%	0 0%
Any Irritability	2 8.3%	1 12.5%
Grade 3 Irritability (Inconsolable)	0 0%	0 0%
Any Headache	1 4.2%	1 12.5%
Grade 3 Headache (Prevents daily activities)	0 0%	0 0%
Any Malaise	4 16.7%	1 12.5%
Grade 3 Malaise (Prevents daily activities)	0 0%	0 0%
Any Myalgia	6 25%	0 0%
Grade 3 Myalgia (Prevents daily activities)	0 0%	0 0%

2. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Time Frame	Day 28 post-single dose or Day 21 post-Dose 2

Outcome Measure Data

Analysis Population Description

Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	23	7
H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, All	54.8	8.6
H3N2 Flu A/Uruguay/716/2007/X175-C Pre, All	24.5	10.5
B Flu B/Florida/04/2006 Pre, All	5.3	5.0
H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, 6-35 mo	46.5	8.6
H3N2 Flu A/Uruguay/716/2007/X175-C Pre, 6-35 mo	17.9	10.5
B Flu B/Florida/04/2006 Pre, 6-35 mo	5.2	5.0
H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, All	320.0	168.1
H3N2 Flu A/Uruguay/716/2007/X175-C Post, All	510.5	226.3
B Flu B/Florida/04/2006 Post, All	26.2	31.2
H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, 6-35 mo	320.0	168.1
H3N2 Flu A/Uruguay/716/2007/X175-C Post, 6-35 mo	424.1	226.3
B Flu B/Florida/04/2006 Post, 6-35 mo	18.3	31.2

3. Other Pre-specified Outcome

Title	Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
Time Frame	Day 28 post-single dose or Day 21 post-Dose 2

Outcome Measure Data

Analysis Population Description

Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group). One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	23	0
H1N1 Flu A/Brisbane/59/2007 IVR-148, Pre 36-59 mo	84.8
H3N2 Flu A/Uruguay/716/2007/ X175-C, Pre 36-59 mo	56.6
B Flu B/Florida/04/2006, Pre 36-59 mo	5.6
H1N1 Flu A/Brisbane/59/2007 IVR-148, Post 36-59 mo	320.0
H3N2 Flu A/Uruguay/716/2007/ X175-C, Post 36-59 mo	780.2
B Flu B/Florida/04/2006, Post 36-59 mo	59.4

4. Other Pre-specified Outcome

Title	Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Description	Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.
Time Frame	Day 28 post-single dose or Day 21 post-Dose 2

Outcome Measure Data

Analysis Population Description

Seroprotection post-vaccination were determined in the per-protocol population. One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	23	7
H1N1 Flu A/Brisbane/59/2007 IVR-148 - All	100 416.7%	100 1250%
H3N2 Flu A/Uruguay/716/2007/X175-C - All	100 416.7%	86 1075%
B Flu B/Florida/04/2006 - All	44 183.3%	71 887.5%
H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo	100 416.7%	100 1250%
H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo	100 416.7%	86 1075%
B Flu B/Florida/04/2006 - 6-35 mo	31 129.2%	71 887.5%

5. Primary Outcome

Title	Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Description	Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Time Frame	Day 0 to Day 3 post-vaccination 2

Outcome Measure Data

Analysis Population Description

Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	0	8
Any Solicited injection site reaction	3 12.5%
Any Tenderness	1 4.2%
Grade 3 Tenderness (Cries when limb is moved)	0 0%
Any Pain	2 8.3%
Grade 3 Pain (Incapacitating)	0 0%
Any Erythema	1 4.2%
Grade 3 Erythema (≥ 5cm)	0 0%
Any Swelling	2 8.3%
Grade 3 Swelling (≥ 5cm)	0 0%
Any Solicited Systemic Reaction	4 16.7%
Any Fever	2 8.3%
Grade 3 Fever (> 103.1 ºF)	0 0%
Any Vomiting	0 0%
Grade 3 Vomiting (≥ 6 Episode per 24 hour)	0 0%
Any Crying Abnormal	2 8.3%
Grade 3 Crying Abnormal (> 3 hours)	0 0%
Any Drowsiness	1 4.2%
Grade 3 Drowsiness (Sleeps most of the time)	0 0%
Any Appetite Lost	0 0%
Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds)	0 0%
Any Irritability	1 4.2%
Grade 3 Irritability (Inconsolable)	0 0%
Any Headache	0 0%
Grade 3 Headache (Prevents daily activities)	0 0%
Any Malaise	1 4.2%
Grade 3 Malaise (Prevents daily activities)	0 0%
Any Myalgia	1 4.2%
Grade 3 Myalgia (Prevents daily activities)	0 0%

6. Other Pre-specified Outcome

Title	Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
Description	Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.
Time Frame	Day 28 post-single dose or Day 21 post-Dose 2

Outcome Measure Data

Analysis Population Description

Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group). One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	23	0
H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo	100 416.7%
H3N2 Flu A/Uruguay/716/2007/ X175-C, 36-59 mo	100 416.7%
B Flu B/Florida/04/2006, 36-59 mo	71 295.8%

7. Other Pre-specified Outcome

Title	Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Description	Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.
Time Frame	Day 28 post-single dose or Day 21 post-Dose 2

Outcome Measure Data

Analysis Population Description

Four-fold rises in vaccine Influenza titers were determined in the per-protocol population. One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	23	7
H1N1 Flu A/Brisbane/59/2007 IVR-148 - All	50 208.3%	86 1075%
H3N2 Flu A/Uruguay/716/2007/X175-C - All	91 379.2%	86 1075%
B Flu B/Florida/04/2006 - All	41 170.8%	71 887.5%
H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo	50 208.3%	86 1075%
H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo	94 391.7%	86 1075%
B Flu B/Florida/04/2006 - 6-35 mo	31 129.2%	71 887.5%

8. Other Pre-specified Outcome

Title	Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
Description	Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.
Time Frame	Day 28 post-single dose or Day 21 post-Dose 2

Outcome Measure Data

Analysis Population Description

Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group). One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data.

Arm/Group Title	Primed Group	Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.	Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
Measure Participants	23	0
H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo	50 208.3%
H3N2 Flu A/Uruguay/716/2007/X-175-C, 36-59 mo	83 345.8%
B Flu B/Florida/04/2006, 36-59 mo	67 279.2%

Adverse Events

Time Frame	Adverse event data were collected through the entire study, 1 or 2 months
Arm/Group Title	Primed Group		Naive/Inadequately Primed Group
Arm/Group Description	Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.		Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
All Cause Mortality
	Primed Group		Naive/Inadequately Primed Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Primed Group		Naive/Inadequately Primed Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Primed Group		Naive/Inadequately Primed Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/24 (16.7%)		4/8 (50%)
Gastrointestinal disorders
Diarrhoea	1/24 (4.2%)	1	1/8 (12.5%)	1
Vomiting	2/24 (8.3%)	3	0/8 (0%)	0
Infections and infestations
Nasopharyngitis	0/24 (0%)	0	1/8 (12.5%)	1
Sinusitis	0/24 (0%)	0	1/8 (12.5%)	1
Respiratory, thoracic and mediastinal disorders
Cough	2/24 (8.3%)	2	2/8 (25%)	3
Rhinorrhoea	1/24 (4.2%)	1	1/8 (12.5%)	1
Skin and subcutaneous tissue disorders
Rash	0/24 (0%)	0	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications