Trial Outcomes & Findings for Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone® (NCT NCT00755274)
NCT ID: NCT00755274
Last Updated: 2016-04-14
Results Overview
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Day 0 to Day 3 post-vaccination 1
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from 15 September to 1 October 2008 in 1 clinical center in the US.
A total of 32 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Primed Group
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.
|
Naive/Inadequately Primed Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
8
|
|
Overall Study
COMPLETED
|
24
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
Baseline characteristics by cohort
| Measure |
Primed Group
n=24 Participants
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.
|
Naive/Inadequately Primed Group
n=8 Participants
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
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
32.8 Months
STANDARD_DEVIATION 10.52 • n=93 Participants
|
22.1 Months
STANDARD_DEVIATION 10.36 • n=4 Participants
|
30.1 Months
STANDARD_DEVIATION 11.34 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
8 participants
n=4 Participants
|
32 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 3 post-vaccination 1Population: Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Outcome measures
| Measure |
Primed Group
n=24 Participants
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.
|
Naive/Inadequately Primed Group
n=8 Participants
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.
|
|---|---|---|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Solicited Injection Site Reaction
|
10 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Tenderness
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Tenderness (Cries When Limb Is Moved)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Pain
|
8 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Pain (Incapacitating)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Erythema
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Erythema (≥ 5 cm)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Swelling
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Swelling (≥ 5 cm)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Solicited Systemic Reaction
|
12 Participants
|
4 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Fever
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Fever (> 103.1 ºF)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Vomiting
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Vomiting (≥ 6 Episodes per 24 hours)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Crying Abnormal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Crying Abnormal (> 3 hours)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Drowsiness
|
4 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Drowsiness (Sleeps most of time)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Appetite Lost
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Irritability
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Irritability (Inconsolable)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Headache
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Headache (Prevents daily activities)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Malaise
|
4 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Malaise (Prevents daily activities)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Any Myalgia
|
6 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Grade 3 Myalgia (Prevents daily activities)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 3 post-vaccination 2Population: 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)
Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.
Outcome measures
| Measure |
Primed Group
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.
|
Naive/Inadequately Primed Group
n=8 Participants
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.
|
|---|---|---|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Solicited injection site reaction
|
—
|
3 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Tenderness
|
—
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Tenderness (Cries when limb is moved)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Pain
|
—
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Pain (Incapacitating)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Erythema
|
—
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Erythema (≥ 5cm)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Swelling
|
—
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Swelling (≥ 5cm)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Solicited Systemic Reaction
|
—
|
4 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Fever
|
—
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Fever (> 103.1 ºF)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Vomiting
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Vomiting (≥ 6 Episode per 24 hour)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Crying Abnormal
|
—
|
2 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Crying Abnormal (> 3 hours)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Drowsiness
|
—
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Drowsiness (Sleeps most of the time)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Appetite Lost
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Appetite Lost (Refuses ≥ 3 meals/feeds)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Irritability
|
—
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Irritability (Inconsolable)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Headache
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Headache (Prevents daily activities)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Malaise
|
—
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Malaise (Prevents daily activities)
|
—
|
0 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Any Myalgia
|
—
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Grade 3 Myalgia (Prevents daily activities)
|
—
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-single dose or Day 21 post-Dose 2Population: 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.
Outcome measures
| Measure |
Primed Group
n=23 Participants
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.
|
Naive/Inadequately Primed Group
n=7 Participants
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.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, All
|
54.8 Titers
Interval 28.5 to 105.5
|
8.6 Titers
Interval 3.5 to 21.3
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H3N2 Flu A/Uruguay/716/2007/X175-C Pre, All
|
24.5 Titers
Interval 12.7 to 47.6
|
10.5 Titers
Interval 3.0 to 37.1
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
B Flu B/Florida/04/2006 Pre, All
|
5.3 Titers
Interval 4.9 to 5.8
|
5.0 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H1N1 Flu A/Brisbane/59/2007 IVR-148 Pre, 6-35 mo
|
46.5 Titers
Interval 21.5 to 101.0
|
8.6 Titers
Interval 3.5 to 21.3
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H3N2 Flu A/Uruguay/716/2007/X175-C Pre, 6-35 mo
|
17.9 Titers
Interval 8.4 to 38.3
|
10.5 Titers
Interval 3.0 to 37.1
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
B Flu B/Florida/04/2006 Pre, 6-35 mo
|
5.2 Titers
Interval 4.8 to 5.7
|
5.0 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, All
|
320.0 Titers
Interval 218.7 to 468.3
|
168.1 Titers
Interval 70.0 to 403.9
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H3N2 Flu A/Uruguay/716/2007/X175-C Post, All
|
510.5 Titers
Interval 305.2 to 854.0
|
226.3 Titers
Interval 62.8 to 815.5
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
B Flu B/Florida/04/2006 Post, All
|
26.2 Titers
Interval 13.1 to 52.4
|
31.2 Titers
Interval 14.0 to 69.5
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H1N1 Flu A/Brisbane/59/2007 IVR-148 Post, 6-35 mo
|
320.0 Titers
Interval 196.8 to 520.4
|
168.1 Titers
Interval 70.0 to 403.9
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H3N2 Flu A/Uruguay/716/2007/X175-C Post, 6-35 mo
|
424.1 Titers
Interval 223.5 to 804.7
|
226.3 Titers
Interval 62.8 to 815.5
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
B Flu B/Florida/04/2006 Post, 6-35 mo
|
18.3 Titers
Interval 8.2 to 40.9
|
31.2 Titers
Interval 14.0 to 69.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-single dose or Day 21 post-Dose 2Population: 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.
Outcome measures
| Measure |
Primed Group
n=23 Participants
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.
|
Naive/Inadequately Primed Group
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.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H1N1 Flu A/Brisbane/59/2007 IVR-148, Pre 36-59 mo
|
84.8 Titers
Interval 16.0 to 448.2
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H3N2 Flu A/Uruguay/716/2007/ X175-C, Pre 36-59 mo
|
56.6 Titers
Interval 12.3 to 260.2
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
B Flu B/Florida/04/2006, Pre 36-59 mo
|
5.6 Titers
Interval 4.2 to 7.6
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H1N1 Flu A/Brisbane/59/2007 IVR-148, Post 36-59 mo
|
320.0 Titers
Interval 142.8 to 716.9
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
H3N2 Flu A/Uruguay/716/2007/ X175-C, Post 36-59 mo
|
780.2 Titers
Interval 274.5 to 2217.2
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination
B Flu B/Florida/04/2006, Post 36-59 mo
|
59.4 Titers
Interval 13.5 to 262.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-single dose or Day 21 post-Dose 2Population: 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.
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.
Outcome measures
| Measure |
Primed Group
n=23 Participants
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.
|
Naive/Inadequately Primed Group
n=7 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
H1N1 Flu A/Brisbane/59/2007 IVR-148 - All
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
H3N2 Flu A/Uruguay/716/2007/X175-C - All
|
100 Percentage of participants
|
86 Percentage of participants
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
B Flu B/Florida/04/2006 - All
|
44 Percentage of participants
|
71 Percentage of participants
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo
|
100 Percentage of participants
|
86 Percentage of participants
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
B Flu B/Florida/04/2006 - 6-35 mo
|
31 Percentage of participants
|
71 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-single dose or Day 21 post-Dose 2Population: 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.
Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.
Outcome measures
| Measure |
Primed Group
n=23 Participants
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.
|
Naive/Inadequately Primed Group
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.
|
|---|---|---|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo
|
100 Percentage of participants
|
—
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
H3N2 Flu A/Uruguay/716/2007/ X175-C, 36-59 mo
|
100 Percentage of participants
|
—
|
|
Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)
B Flu B/Florida/04/2006, 36-59 mo
|
71 Percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-single dose or Day 21 post-Dose 2Population: 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.
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.
Outcome measures
| Measure |
Primed Group
n=23 Participants
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.
|
Naive/Inadequately Primed Group
n=7 Participants
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.
|
|---|---|---|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
H1N1 Flu A/Brisbane/59/2007 IVR-148 - All
|
50 Percentage of participants
|
86 Percentage of participants
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
H3N2 Flu A/Uruguay/716/2007/X175-C - All
|
91 Percentage of participants
|
86 Percentage of participants
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
B Flu B/Florida/04/2006 - All
|
41 Percentage of participants
|
71 Percentage of participants
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
H1N1 Flu A/Brisbane/59/2007 IVR-148 - 6-35 mo
|
50 Percentage of participants
|
86 Percentage of participants
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
H3N2 Flu A/Uruguay/716/2007/X175-C - 6-35 mo
|
94 Percentage of participants
|
86 Percentage of participants
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
B Flu B/Florida/04/2006 - 6-35 mo
|
31 Percentage of participants
|
71 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 post-single dose or Day 21 post-Dose 2Population: 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.
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.
Outcome measures
| Measure |
Primed Group
n=23 Participants
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.
|
Naive/Inadequately Primed Group
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.
|
|---|---|---|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
H1N1 Flu A/Brisbane/59/2007 IVR-148, 36-59 mo
|
50 Percentage of participants
|
—
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
H3N2 Flu A/Uruguay/716/2007/X-175-C, 36-59 mo
|
83 Percentage of participants
|
—
|
|
Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)
B Flu B/Florida/04/2006, 36-59 mo
|
67 Percentage of participants
|
—
|
Adverse Events
Primed Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Naive/Inadequately Primed Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primed Group
n=24 participants at risk
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.
|
Naive/Inadequately Primed Group
n=8 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected through the entire study, 1 or 2 months
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through the entire study, 1 or 2 months
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Number of events 3 • Adverse event data were collected through the entire study, 1 or 2 months
|
0.00%
0/8 • Adverse event data were collected through the entire study, 1 or 2 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • Adverse event data were collected through the entire study, 1 or 2 months
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through the entire study, 1 or 2 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24 • Adverse event data were collected through the entire study, 1 or 2 months
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through the entire study, 1 or 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected through the entire study, 1 or 2 months
|
25.0%
2/8 • Number of events 3 • Adverse event data were collected through the entire study, 1 or 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected through the entire study, 1 or 2 months
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through the entire study, 1 or 2 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • Adverse event data were collected through the entire study, 1 or 2 months
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected through the entire study, 1 or 2 months
|
Additional Information
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