Trial Outcomes & Findings for Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age (NCT NCT00885105)

NCT ID: NCT00885105

Last Updated: 2016-04-14

Results Overview

Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 242 participants
• Primary outcome timeframe: Day 28 Post-vaccination
• Results posted on: 2016-04-14

Participant Flow

Participants were enrolled from 17 October 2005 to 05 January 2006 at 7 medical centers in the US.

A total of 242 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participant milestones

Measure	Fluzone® Vaccine-Primed Group Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Study STARTED	112	130
Overall Study COMPLETED	111	120
Overall Study NOT COMPLETED	1	10

Reasons for withdrawal

Measure	Fluzone® Vaccine-Primed Group Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Overall Study Withdrawal by Subject	0	8
Overall Study Adverse Event	1	0
Overall Study Protocol Violation	0	2

Baseline Characteristics

Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age

Baseline characteristics by cohort

Measure	Fluzone® Vaccine-Primed Group n=112 Participants Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=130 Participants Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Total n=242 Participants Total of all reporting groups
Age, Categorical <=18 years	112 Participants n=5 Participants	130 Participants n=7 Participants	242 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.29 Months STANDARD_DEVIATION 1.1 • n=5 Participants	7.28 Months STANDARD_DEVIATION 1.47 • n=7 Participants	7.28 Months STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	60 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	70 Participants n=7 Participants	129 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants	130 participants n=7 Participants	242 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 Post-vaccination

Population: Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.

Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.

Outcome measures

Measure	Fluzone® Vaccine-Primed Group n=51 Participants Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=51 Participants Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. A/New Caledonia/20/99 Post-Dose 1	44 Percentage of Participants	34 Percentage of Participants
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. A/New York/55/2004 Post-Dose 1	31 Percentage of Participants	74 Percentage of Participants
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. B/Jiangsu/310/2003 Post-Dose 1	22 Percentage of Participants	6 Percentage of Participants
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. A/New Caledonia/20/99 Post-Dose 2	69 Percentage of Participants	86 Percentage of Participants
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. A/New York/55/2004 Post-Dose 2	84 Percentage of Participants	100 Percentage of Participants
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine. B/Jiangsu/310/2003 Post-Dose 2	28 Percentage of Participants	47 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 Post-vaccination

Population: Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.

Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.

Outcome measures

Measure	Fluzone® Vaccine-Primed Group n=51 Participants Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=51 Participants Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. A/New Caledonia/20/99 Post-Dose 1	30.5 Titers Interval 22.3 to 41.8	18.9 Titers Interval 14.1 to 25.4
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. A/New York/55/2004 Post-Dose 1	21.4 Titers Interval 15.7 to 29.3	65.6 Titers Interval 47.7 to 90.2
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. B/Jiangsu/310/2003 Post-Dose 1	13.2 Titers Interval 9.89 to 17.6	6.2 Titers Interval 5.27 to 7.29
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. B/Jiangsu/310/2003 Post-Dose 2	20.7 Titers Interval 16.1 to 26.6	23.9 Titers Interval 18.2 to 31.3
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. A/New Caledonia/20/99 Post-Dose 2	38.1 Titers Interval 29.6 to 49.2	104 Titers Interval 77.1 to 139.0
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine. A/New York/55/2004 Post-Dose 2	78.9 Titers Interval 61.3 to 102.0	277 Titers Interval 223.0 to 346.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 Post-vaccination

Population: GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.

Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).

Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.

The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.

Outcome measures

Measure	Fluzone® Vaccine-Primed Group n=94 Participants Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=104 Participants Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. Pertussis Toxoid (EU/mL)	57.9 Titers Interval 47.9 to 69.9	69.5 Titers Interval 57.6 to 83.7
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. Fimbriae Types 2 and 3 (EU/mL)	26.7 Titers Interval 18.1 to 39.5	11.6 Titers Interval 7.76 to 17.4
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. Diphtheria (IU/mL)	0.230 Titers Interval 0.18 to 0.294	0.251 Titers Interval 0.191 to 0.329
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. Tetanus (IU/mL)	0.976 Titers Interval 0.694 to 1.37	0.980 Titers Interval 0.72 to 1.33
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. Filamentous Hemagglutinin (EU/mL)	37.3 Titers Interval 29.5 to 47.1	47.3 Titers Interval 37.9 to 59.0
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine. Pertactin (EU/mL)	22.0 Titers Interval 16.8 to 28.8	33.6 Titers Interval 26.1 to 43.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 post-vaccination

Population: Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.

Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).

Outcome measures

Measure	Fluzone® Vaccine-Primed Group n=91 Participants Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=97 Participants Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Polyribosylribitol Phosphate (mcg/mL)	1.69 Titers Interval 1.16 to 2.46	2.12 Titers Interval 1.49 to 3.02
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Pneumococcal 4 (mcg/mL)	1.02 Titers Interval 0.854 to 1.22	0.956 Titers Interval 0.781 to 1.17
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Pneumococcal 9V (mcg/mL)	0.974 Titers Interval 0.812 to 1.17	1.20 Titers Interval 0.981 to 1.46
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Pneumococcal 14 (mcg/mL)	4.98 Titers Interval 4.12 to 6.03	5.54 Titers Interval 4.56 to 6.74
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Pneumococcal 18C (mcg/mL)	0.783 Titers Interval 0.646 to 0.95	0.790 Titers Interval 0.644 to 0.97
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Pneumococcal 19F (mcg/mL)	1.49 Titers Interval 1.27 to 1.74	1.26 Titers Interval 1.05 to 1.51
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Pneumococcal 23F (mcg/mL)	0.920 Titers Interval 0.737 to 1.15	1.00 Titers Interval 0.779 to 1.29
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Pneumococcal 6B (mcg/mL)	1.14 Titers Interval 0.906 to 1.44	1.24 Titers Interval 0.949 to 1.61

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 post-vaccination

Population: Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.

Antibodies to polio viruses were measured by a serum neutralization assay.

Outcome measures

Measure	Fluzone® Vaccine-Primed Group n=94 Participants Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=104 Participants Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Polio Type 1 (1/dil)	555 Titers Interval 415.0 to 742.0	1072 Titers Interval 814.0 to 1411.0
Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Polio Type 2 (1/dil)	356 Titers Interval 268.0 to 474.0	550 Titers Interval 411.0 to 736.0
Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine. Polio Type 3 (1/dil)	394 Titers Interval 282.0 to 551.0	571 Titers Interval 397.0 to 822.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 0 up to 7 post-vaccination

Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population

Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.

Outcome measures

Measure	Fluzone® Vaccine-Primed Group n=112 Participants Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=130 Participants Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Tenderness	34 Percentage of Participants	28 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grd 3 Tenderness (injected limb movement reduced)	1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Redness (> 0.5 cm)	12 Percentage of Participants	10 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Swelling (≥ 5.0 cm)	1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Solicited Injection Site Reaction - Any Dose	51 Percentage of Participants	51 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Redness (≥ 5.0 cm)	2 Percentage of Participants	1 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Swelling (> 0.5 cm)	10 Percentage of Participants	5 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Solicited Systemic Reaction Post-Dose 1	79 Percentage of Participants	82 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Fever	14 Percentage of Participants	34 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Fever ≥ 103.3 ºF)	0 Percentage of Participants	1 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Vomiting	8 Percentage of Participants	12 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Vomiting (≥ 6 episodes per 24 hours)	0 Percentage of Participants	3 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Abnormal Crying	39 Percentage of Participants	26 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Abnormal Crying (> 3 hours)	6 Percentage of Participants	3 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Drowsiness	29 Percentage of Participants	34 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Drowsiness (difficulty waking up)	0 Percentage of Participants	1 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Loss of Appetite	29 Percentage of Participants	28 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grd 3 Loss of Appetite (refuses ≥ 3 or most feeds)	0 Percentage of Participants	1 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Irritability	56 Percentage of Participants	43 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Irritability (inconsolable)	3 Percentage of Participants	2 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Solicited Systemic Reaction Post-Dose 2	64 Percentage of Participants	62 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Fever (≥ 103.3 ºF)	1 Percentage of Participants	2 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Solicited Systemic Reaction - Any Dose	86 Percentage of Participants	90 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Solicited Injection Site Reaction Post-Dose 1	45 Percentage of Participants	42 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Any Solicited Injection Site Reaction Post-Dose 2	36 Percentage of Participants	34 Percentage of Participants
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine. Grade 3 Redness ≥ 5.0 cm)	0 Percentage of Participants	0 Percentage of Participants

Adverse Events

Fluzone® Vaccine-Primed Group

Serious events: 5 serious events

Other events: 57 other events

Deaths: 0 deaths

Influenza Vaccine-Naive Group

Serious events: 1 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluzone® Vaccine-Primed Group n=112 participants at risk Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=130 participants at risk Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Infections and infestations Gastroenteritis viral	0.89% 1/112 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.00% 0/130 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Pneumonia	0.89% 1/112 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.77% 1/130 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Pneumonia respiratory syncytial viral	0.89% 1/112 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.00% 0/130 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Metabolism and nutrition disorders Dehydration	0.89% 1/112 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.00% 0/130 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Congenital, familial and genetic disorders Sickle cell anaemia with crisis	0.00% 0/112 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.77% 1/130 • Number of events 3 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Ear and labyrinth disorders Deafness bilateral	0.89% 1/112 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.00% 0/130 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Bronchiolitis	0.89% 1/112 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.00% 0/130 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Gastroenteritis	0.00% 0/112 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	0.77% 1/130 • Number of events 1 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2

Other adverse events

Measure	Fluzone® Vaccine-Primed Group n=112 participants at risk Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.	Influenza Vaccine-Naive Group n=130 participants at risk Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
Eye disorders Conjunctivitis	4.5% 5/112 • Number of events 5 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	5.4% 7/130 • Number of events 9 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
General disorders Pyrexia	7.1% 8/112 • Number of events 8 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	4.6% 6/130 • Number of events 6 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Bronchiolitis	4.5% 5/112 • Number of events 5 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	6.2% 8/130 • Number of events 8 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Croup infectious	6.2% 7/112 • Number of events 7 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	1.5% 2/130 • Number of events 2 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Otitis media	26.8% 30/112 • Number of events 34 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	23.1% 30/130 • Number of events 31 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Infections and infestations Upper respiratory tract infection	17.9% 20/112 • Number of events 21 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	18.5% 24/130 • Number of events 26 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Respiratory, thoracic and mediastinal disorders Cough	6.2% 7/112 • Number of events 7 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	9.2% 12/130 • Number of events 13 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.7% 3/112 • Number of events 3 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2	6.2% 8/130 • Number of events 8 • Adverse event data were collected over a period of 8 months. Six months post-vaccination 2

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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
• Publication restrictions are in place

Restriction type: OTHER