Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00980005
Collaborator
(none)
2,116
28
2
8.1
75.6
9.3
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children
Study Start Date
:
Oct 13, 2009
Actual Primary Completion Date
:
Mar 2, 2010
Actual Study Completion Date
:
Jun 17, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Flulaval Group subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. |
Biological: GSK investigational vaccine GSK1557482A
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
|
| Active Comparator: Fluzone Group subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
Biological: Fluzone®
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. [At Day 0 and 28 after last vaccine dose.]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
- Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. [At Day 28 after last vaccine dose.]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
Secondary Outcome Measures
- Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. [At Day 0 and 28 after last vaccine dose.]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
- Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. [At Day 28 after last vaccine dose.]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
- Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. [At Day 0 and 28 after last vaccine dose.]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
- Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. [At Day 0 and 28 after last vaccine dose.]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
- Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. [At Day 0 and at Day 28 after last vaccine dose]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
- Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. [At Day 0 and at Day 28 after last vaccine dose]
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
- Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). [During a 4-day follow-up period (Days 0-3) after vaccination.]
The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.
- Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). [During a 4-day follow-up period (Days 0-3) after vaccination.]
The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination.
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). [During a 4-day follow-up period (Days 0-3) after vaccination.]
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.
- Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. [During a 4-day follow-up period (Days 0-3) after vaccination.]
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). [During a 28 day follow-up period (Days 0-27) after vaccination.]
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. [During a 28 day follow-up period (Days 0-27) after vaccination.]
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects Reporting Medically Attended Adverse Events (MAEs). [During the entire study period (From Day 0 up to Day 180).]
For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
- Number of Subjects Reporting Serious Adverse Events (SAEs). [During the entire study period (From Day 0 up to Day 180).]
An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
-
A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
-
Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
-
Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
-
Female subjects of non-childbearing potential may be enrolled in the study.
-
Female subjects of childbearing potential may be enrolled in the study, if the subject:
-
has practiced adequate contraception for 30 days prior to vaccination, and
-
has a negative pregnancy test on the day of vaccination, and
-
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
-
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
-
Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
-
Child in care
-
Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
-
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
-
History of hypersensitivity to any vaccine.
-
History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
-
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
-
Acute disease and/or fever at the time of enrolment.
-
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
-
Pregnant or lactating female.
-
History of chronic alcohol consumption and/or drug abuse.
-
Female planning to become pregnant or planning to discontinue contraceptive precautions.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Birmingham | Alabama | United States | 35205 |
| 2 | GSK Investigational Site | Benton | Arkansas | United States | 72015 |
| 3 | GSK Investigational Site | Huntington Beach | California | United States | 92647 |
| 4 | GSK Investigational Site | Paramount | California | United States | 90723 |
| 5 | GSK Investigational Site | West Covina | California | United States | 91790 |
| 6 | GSK Investigational Site | Marietta | Georgia | United States | 30062 |
| 7 | GSK Investigational Site | Woodstock | Georgia | United States | 30189 |
| 8 | GSK Investigational Site | DeKalb | Illinois | United States | 60115 |
| 9 | GSK Investigational Site | Newton | Kansas | United States | 67114 |
| 10 | GSK Investigational Site | Wichita | Kansas | United States | 67207 |
| 11 | GSK Investigational Site | Woburn | Massachusetts | United States | 01801 |
| 12 | GSK Investigational Site | Stevensville | Michigan | United States | 49127 |
| 13 | GSK Investigational Site | Saint Louis | Missouri | United States | 63141 |
| 14 | GSK Investigational Site | Henderson | Nevada | United States | 89015 |
| 15 | GSK Investigational Site | Cortland | New York | United States | 13045 |
| 16 | GSK Investigational Site | Syracuse | New York | United States | 13210 |
| 17 | GSK Investigational Site | Cary | North Carolina | United States | 27518 |
| 18 | GSK Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 19 | GSK Investigational Site | Austintown | Ohio | United States | 44515 |
| 20 | GSK Investigational Site | Albany | Oregon | United States | 97322 |
| 21 | GSK Investigational Site | Erie | Pennsylvania | United States | 16505 |
| 22 | GSK Investigational Site | Hermitage | Pennsylvania | United States | 16148 |
| 23 | GSK Investigational Site | Charleston | South Carolina | United States | 29406 |
| 24 | GSK Investigational Site | Austin | Texas | United States | 78705 |
| 25 | GSK Investigational Site | Houston | Texas | United States | 77055 |
| 26 | GSK Investigational Site | Orem | Utah | United States | 84057 |
| 27 | GSK Investigational Site | Provo | Utah | United States | 84604 |
| 28 | GSK Investigational Site | Burke | Virginia | United States | 22015 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00980005
Other Study ID Numbers:
- 112999
First Posted:
Sep 18, 2009
Last Update Posted:
Sep 21, 2018
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Subjects were stratified by age-strata: 3-4, 5-8 and 9-17 years and received vaccine according to their priming status: primed subjects received a 2-dose priming immunization in a previous season, whereas unprimed subjects had not. Blood samples: at Days 0 - 28 for primed subjects and subjects 9-17 years and at Days 0-56 for unprimed subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Period Title: Overall Study | ||
| STARTED | 1055 | 1061 |
| COMPLETED | 1008 | 998 |
| NOT COMPLETED | 47 | 63 |
Baseline Characteristics
| Arm/Group Title | Flulaval Group | Fluzone Group | Total |
|---|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. | Total of all reporting groups |
| Overall Participants | 1055 | 1061 | 2116 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
7.8
(4.18)
|
7.8
(4.10)
|
7.8
(4.14)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
500
47.4%
|
496
46.7%
|
996
47.1%
|
| Male |
555
52.6%
|
565
53.3%
|
1120
52.9%
|
Outcome Measures
| Title | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). |
| Time Frame | At Day 0 and 28 after last vaccine dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 979 |
| A/Brisbane [at Day 0] |
46.0
|
45.8
|
| A/Brisbane [at Day 28] |
320.9
|
329.4
|
| A/Uruguay [at Day 0] |
57.1
|
63.9
|
| A/Uruguay [at Day 28] |
414.7
|
451.9
|
| B/Brisbane [at Day 0] |
16.6
|
16.8
|
| B/Brisbane [at Day 28] |
213.7
|
200.2
|
| Title | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. |
| Time Frame | At Day 28 after last vaccine dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 978 |
| A/Brisbane |
590
55.9%
|
569
53.6%
|
| A/Uruguay |
673
63.8%
|
647
61%
|
| B/Brisbane |
800
75.8%
|
769
72.5%
|
| Title | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Time Frame | At Day 0 and 28 after last vaccine dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 979 |
| A/Brisbane at Day 0 [3-4 years] |
38.4
|
34.4
|
| A/Brisbane at Day 28 [3-4 years] |
263.5
|
281.9
|
| A/Brisbane at Day 0 [5-8 years] |
40.2
|
41.4
|
| A/Brisbane at Day 28 [5-8 years] |
251.8
|
251.5
|
| A/Brisbane at Day 0 [9-17 years] |
60.2
|
61.9
|
| A/Brisbane at Day 28 [9-17 years] |
473.6
|
478.2
|
| A/Uruguay at Day 0 [3-4 years] |
38.7
|
50.2
|
| A/Uruguay at Day 28 [3-4 years] |
322.8
|
418.3
|
| A/Uruguay at Day 0 [5-8 years] |
78.5
|
78.1
|
| A/Uruguay at Day 28 [5-8 years] |
476.3
|
494.2
|
| A/Uruguay at Day 0 [9-17 years] |
56.3
|
62.6
|
| A/Uruguay at Day 28 [9-17 years] |
438.4
|
437.8
|
| B/Brisbane at Day 0 [3-4 years] |
13.1
|
11.6
|
| B/Brisbane at Day 28 [3-4 years] |
174.1
|
148.5
|
| B/Brisbane at Day 0 [5-8 years] |
16.2
|
16.9
|
| B/Brisbane at Day 28 [5-8 years] |
196.8
|
202.8
|
| B/Brisbane at Day 0 [9-17 years] |
20.5
|
21.7
|
| B/Brisbane at Day 28 [9-17 years] |
271.1
|
244.6
|
| Title | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Time Frame | At Day 28 after last vaccine dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 978 |
| A/Brisbane [3-4 years] |
161
15.3%
|
177
16.7%
|
| A/Brisbane [5-8 years] |
211
20%
|
191
18%
|
| A/Brisbane [9-17 years] |
218
20.7%
|
201
18.9%
|
| A/Uruguay [3-4 years] |
203
19.2%
|
190
17.9%
|
| A/Uruguay [5-8 years] |
233
22.1%
|
228
21.5%
|
| A/Uruguay [9-17 years] |
237
22.5%
|
229
21.6%
|
| B/Brisbane [3-4 years] |
227
21.5%
|
214
20.2%
|
| B/Brisbane [5-8 years] |
289
27.4%
|
293
27.6%
|
| B/Brisbane [9-17 years] |
284
26.9%
|
262
24.7%
|
| Title | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. |
| Time Frame | At Day 0 and 28 after last vaccine dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 979 |
| A/Brisbane [at Day 0] |
640
60.7%
|
639
60.2%
|
| A/Brisbane [at Day 28] |
969
91.8%
|
965
91%
|
| A/Uruguay [at Day 0] |
676
64.1%
|
690
65%
|
| A/Uruguay [at Day 28] |
970
91.9%
|
973
91.7%
|
| B/Brisbane [at Day 0] |
359
34%
|
360
33.9%
|
| B/Brisbane [at Day 28] |
936
88.7%
|
925
87.2%
|
| Title | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Time Frame | At Day 0 and 28 after last vaccine dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 979 |
| A/Brisbane at Day 0 [3-4 years] |
155
14.7%
|
145
13.7%
|
| A/Brisbane at Day 28 [3-4 years] |
265
25.1%
|
258
24.3%
|
| A/Brisbane at Day 0 [5-8 years] |
227
21.5%
|
228
21.5%
|
| A/Brisbane at Day 28 [5-8 years] |
347
32.9%
|
346
32.6%
|
| A/Brisbane at Day 0 [9-17 years] |
258
24.5%
|
266
25.1%
|
| A/Brisbane at Day 28 [9-17 years] |
357
33.8%
|
361
34%
|
| A/Uruguay at Day 0 [3-4 years] |
153
14.5%
|
158
14.9%
|
| A/Uruguay at Day 28 [3-4 years] |
265
25.1%
|
259
24.4%
|
| A/Uruguay at Day 0 [5-8 years] |
267
25.3%
|
269
25.4%
|
| A/Uruguay at Day 28 [5-8 years] |
349
33.1%
|
351
33.1%
|
| A/Uruguay at Day 0 [9-17 years] |
256
24.3%
|
263
24.8%
|
| A/Uruguay at Day 28 [9-17 years] ) |
356
33.7%
|
363
34.2%
|
| B/Brisbane at Day 0 [3-4 years] |
80
7.6%
|
68
6.4%
|
| B/Brisbane at Day 28 [3-4 years] |
254
24.1%
|
239
22.5%
|
| B/Brisbane at Day 0 [5-8 years] |
127
12%
|
127
12%
|
| B/Brisbane at Day 28 [5-8 years] |
334
31.7%
|
335
31.6%
|
| B/Brisbane at Day 0 [9-17 years] |
152
14.4%
|
165
15.6%
|
| B/Brisbane at Day 28 [9-17 years] |
348
33%
|
351
33.1%
|
| Title | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. |
| Time Frame | At Day 0 and at Day 28 after last vaccine dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 978 |
| A/Brisbane |
7.0
|
7.2
|
| A/Uruguay |
7.3
|
7.1
|
| B/Brisbane |
12.8
|
11.9
|
| Title | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. |
|---|---|
| Description | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Time Frame | At Day 0 and at Day 28 after last vaccine dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 987 | 978 |
| A/Brisbane [3-4 years] |
6.9
|
8.2
|
| A/Brisbane [5-8 years] |
6.3
|
6.1
|
| A/Brisbane [9-17 years] |
7.9
|
7.7
|
| A/Uruguay [3-4 years] |
8.4
|
8.3
|
| A/Uruguay [5-8 years] |
6.1
|
6.3
|
| A/Uruguay [9-17 years] |
7.8
|
7.0
|
| B/Brisbane [3-4 years] |
13.3
|
12.8
|
| B/Brisbane [5-8 years] |
12.2
|
12.0
|
| B/Brisbane [9-17 years] |
13.2
|
11.3
|
| Title | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). |
|---|---|
| Description | The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination. |
| Time Frame | During a 4-day follow-up period (Days 0-3) after vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group | Flulaval Less Than 5 Years Old Group | Fluzone Les Than 5 Years Old Group |
|---|---|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. | Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status. | Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age |
| Measure Participants | 0 | 0 | 293 | 279 |
| Any drowsiness |
61
5.8%
|
63
5.9%
|
||
| Grade 3 drowsiness |
4
0.4%
|
2
0.2%
|
||
| Drowsiness related to vaccination |
57
5.4%
|
56
5.3%
|
||
| Any irritability |
86
8.2%
|
87
8.2%
|
||
| Grade 3 irritability |
6
0.6%
|
4
0.4%
|
||
| Irritability related to vaccination |
81
7.7%
|
81
7.6%
|
||
| Any loss of appetite |
52
4.9%
|
47
4.4%
|
||
| Grade 3 loss of appetite |
7
0.7%
|
2
0.2%
|
||
| Loss of appetite related to vaccination |
45
4.3%
|
42
4%
|
||
| Fever >= 38.0°C |
15
1.4%
|
10
0.9%
|
||
| Fever >= 39.0°C - <= 40.0°C |
3
0.3%
|
2
0.2%
|
||
| Fever related to vaccination |
14
1.3%
|
8
0.8%
|
| Title | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). |
|---|---|
| Description | The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination. |
| Time Frame | During a 4-day follow-up period (Days 0-3) after vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group | Flulaval 5 Years of Age and Older Group | Fluzone 5 Years of Age and Older Group |
|---|---|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. | Subjects aged 5 years and above and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status. | Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age |
| Measure Participants | 0 | 0 | 750 | 747 |
| Any arthralgia |
70
6.6%
|
80
7.5%
|
||
| Grade 3 arthralgia |
2
0.2%
|
2
0.2%
|
||
| Arthralgia related to vaccination |
65
6.2%
|
74
7%
|
||
| Any fatigue |
138
13.1%
|
137
12.9%
|
||
| Grade 3 fatigue |
11
1%
|
10
0.9%
|
||
| Fatigue related to vaccination |
119
11.3%
|
117
11%
|
||
| Any headache |
141
13.4%
|
131
12.3%
|
||
| Grade 3 headache |
6
0.6%
|
4
0.4%
|
||
| Headache related to vaccination |
115
10.9%
|
105
9.9%
|
||
| Any muscle aches |
200
19%
|
189
17.8%
|
||
| Grade 3 muscle aches |
6
0.6%
|
7
0.7%
|
||
| Muscle aches related to vaccination |
180
17.1%
|
179
16.9%
|
||
| Any shivering |
45
4.3%
|
40
3.8%
|
||
| Grade 3 shivering |
2
0.2%
|
3
0.3%
|
||
| Shivering related to vaccination |
36
3.4%
|
31
2.9%
|
||
| Fever >= 38.0°C |
36
3.4%
|
36
3.4%
|
||
| Fever >= 39.0°C - <= 40.0°C |
12
1.1%
|
13
1.2%
|
||
| Temperature related to vaccination |
27
2.6%
|
25
2.4%
|
| Title | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs). |
|---|---|
| Description | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. |
| Time Frame | During a 4-day follow-up period (Days 0-3) after vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 1043 | 1026 |
| Any pain |
615
58.3%
|
584
55%
|
| Grade 3 pain |
26
2.5%
|
28
2.6%
|
| Any redness |
57
5.4%
|
53
5%
|
| Grade 3 redness |
2
0.2%
|
1
0.1%
|
| Any swelling |
51
4.8%
|
59
5.6%
|
| Grade 3 swelling |
1
0.1%
|
0
0%
|
| Title | Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata. |
|---|---|
| Description | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Time Frame | During a 4-day follow-up period (Days 0-3) after vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 1043 | 1026 |
| Any pain [3-4 years] |
139
13.2%
|
130
12.3%
|
| Grade 3 pain [3-4 years] |
5
0.5%
|
4
0.4%
|
| Any redness [3-4 years] |
14
1.3%
|
18
1.7%
|
| Grade 3 redness [3-4 years] |
0
0%
|
0
0%
|
| Any swelling [3-4 years] |
9
0.9%
|
11
1%
|
| Grade 3 swelling [3-4 years] |
0
0%
|
0
0%
|
| Any pain [5-8 years] |
252
23.9%
|
249
23.5%
|
| Grade 3 pain [5-8 years] |
16
1.5%
|
18
1.7%
|
| Any redness [5-8 years] |
30
2.8%
|
22
2.1%
|
| Grade 3 redness [5-8 years] |
2
0.2%
|
1
0.1%
|
| Any swelling [5-8 years] |
24
2.3%
|
28
2.6%
|
| Grade 3 swelling [5-8 years] |
1
0.1%
|
0
0%
|
| Any pain [9-17 years] |
224
21.2%
|
205
19.3%
|
| Grade 3 pain [9-17 years] |
5
0.5%
|
6
0.6%
|
| Any redness [9-17 years] |
13
1.2%
|
13
1.2%
|
| Grade 3 redness [9-17 years] |
0
0%
|
0
0%
|
| Any swelling [9-17 years] |
18
1.7%
|
20
1.9%
|
| Grade 3 swelling [9-17 years] |
0
0%
|
0
0%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). |
|---|---|
| Description | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | During a 28 day follow-up period (Days 0-27) after vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 1055 | 1061 |
| Any AE(s) |
421
39.9%
|
387
36.5%
|
| Grade 3 AE(s) |
81
7.7%
|
83
7.8%
|
| Related AE(s) |
65
6.2%
|
57
5.4%
|
| Title | Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata. |
|---|---|
| Description | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | During a 28 day follow-up period (Days 0-27) after vaccination. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 1055 | 1061 |
| Any AE(s) [3-4 years] |
134
12.7%
|
128
12.1%
|
| Grade 3 AE(s) [3-4 years] |
23
2.2%
|
25
2.4%
|
| Related AE(s) [3-4 years] |
17
1.6%
|
16
1.5%
|
| Any AE(s) [5-8 years] |
175
16.6%
|
149
14%
|
| Grade 3 AE(s) [5-8 years] |
36
3.4%
|
32
3%
|
| Related AE(s) [5-8 years] |
32
3%
|
24
2.3%
|
| Any AE(s) [9-17 years] |
112
10.6%
|
110
10.4%
|
| Grade 3 AE(s) [9-17 years] |
22
2.1%
|
26
2.5%
|
| Related AE(s) [9-17 years] |
16
1.5%
|
17
1.6%
|
| Title | Number of Subjects Reporting Medically Attended Adverse Events (MAEs). |
|---|---|
| Description | For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. |
| Time Frame | During the entire study period (From Day 0 up to Day 180). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 1055 | 1061 |
| Count of Participants [Participants] |
447
42.4%
|
432
40.7%
|
| Title | Number of Subjects Reporting Serious Adverse Events (SAEs). |
|---|---|
| Description | An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
| Time Frame | During the entire study period (From Day 0 up to Day 180). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Total Vaccinated cohort included all vaccinated subjects. |
| Arm/Group Title | Flulaval Group | Fluzone Group |
|---|---|---|
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. |
| Measure Participants | 1055 | 1061 |
| Count of Participants [Participants] |
10
0.9%
|
6
0.6%
|
Adverse Events
| Time Frame | Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination. | |||
| Arm/Group Title | Flulaval Group | Fluzone Group | ||
| Arm/Group Description | subjects received Flulaval™ vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. | ||
All Cause Mortality |
||||
| Flulaval Group | Fluzone Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Flulaval Group | Fluzone Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/1055 (0.9%) | 6/1061 (0.6%) | ||
| Gastrointestinal disorders | ||||
| Vomiting | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Immune system disorders | ||||
| Type 1 diabetes mellitus | 0/1055 (0%) | 1/1061 (0.1%) | ||
| Infections and infestations | ||||
| Pneumonia | 2/1055 (0.2%) | 1/1061 (0.1%) | ||
| Herpangina | 1/1055 (0.1%) | 1/1061 (0.1%) | ||
| Oral candidiasis | 1/1055 (0.1%) | 1/1061 (0.1%) | ||
| Abscess | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Appendicitis | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Bronchiolitis | 0/1055 (0%) | 1/1061 (0.1%) | ||
| Cellulitis | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Gastroenteritis | 0/1055 (0%) | 1/1061 (0.1%) | ||
| H1N1 influenza | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Forearm fracture | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Sinus polyp | 0/1055 (0%) | 1/1061 (0.1%) | ||
| Nervous system disorders | ||||
| Convulsion | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Psychiatric disorders | ||||
| Affective disorder | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Attention deficit/hyperactivity disorder | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Oppositional defiant disorder | 1/1055 (0.1%) | 0/1061 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 0/1055 (0%) | 1/1061 (0.1%) | ||
| Hypoxia | 0/1055 (0%) | 1/1061 (0.1%) | ||
| Respiratory distress | 1/1055 (0.1%) | 0/1061 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Flulaval Group | Fluzone Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 742/1055 (70.3%) | 710/1061 (66.9%) | ||
| General disorders | ||||
| Pyrexia | 62/1055 (5.9%) | 60/1061 (5.7%) | ||
| Arthralgia | 70/750 (9.3%) | 80/747 (10.7%) | ||
| Fatigue | 138/750 (18.4%) | 137/747 (18.3%) | ||
| Headache | 141/750 (18.8%) | 131/747 (17.5%) | ||
| Muscle aches | 200/750 (26.7%) | 189/747 (25.3%) | ||
| Shivering | 45/750 (6%) | 40/747 (5.4%) | ||
| Drowsiness | 61/293 (20.8%) | 63/279 (22.6%) | ||
| Irritability | 86/293 (29.4%) | 87/279 (31.2%) | ||
| Loss of appetite | 52/293 (17.7%) | 47/279 (16.8%) | ||
| Temperature | 15/293 (5.1%) | 10/279 (3.6%) | ||
| Pain | 615/1043 (59%) | 584/1026 (56.9%) | ||
| Redness | 57/1043 (5.5%) | 53/1026 (5.2%) | ||
| Swelling | 51/1043 (4.9%) | 59/1026 (5.8%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 129/1055 (12.2%) | 115/1061 (10.8%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00980005
Other Study ID Numbers:
- 112999
First Posted:
Sep 18, 2009
Last Update Posted:
Sep 21, 2018
Last Verified:
Sep 1, 2016