Influenza
Conditions
Keywords
Children, Influenza, Safety, Immunogenicity, Vaccine
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age. This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.
Interventions
BIOLOGICALInfluenza vaccine GSK2186877A formulation 1
Intramuscular administration, 2 doses
BIOLOGICALInfluenza vaccine GSK2186877A formulation 2
Intramuscular administration, 1 dose
BIOLOGICALFluarix
Intramuscular administration, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
Exclusion criteria
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: * Child in care * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Prior receipt of any influenza vaccination (seasonal or pandemic) or planned administration during the study period. * Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone \>0.5 mg/kg of body weight, or equivalent. Inhaled and topical steroids are allowed. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * A family history of congenital or hereditary immunodeficiency. * Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to consumption of egg proteins. * History of any neurological disorders or seizures (including febrile convulsion). * Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination. * Acute disease and/or fever at the time of enrolment: * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>=38.0°C on rectal setting. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever might be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period. * Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Fever Grade 2 or Higher | Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A | Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects Seropositive to HI Antibodies | At Day 0 and Day 42 | A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens. |
| The Number of Subjects Seroprotected to HI Antibodies | At Day 0 and Day 42 | A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens. |
| The Number of Subjects Seroconverted to HI Antibodies | Day 42 | A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens. |
| HI Antibody Geometric Mean Fold Rise (GMFR) | Day 42 | GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A | Grade 3 redness and swelling was \> 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade. |
| Duration of Solicited Local AEs | Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A | Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group. |
| Haemagglutination Inhibition (HI) Antibody Titers | At Day 0 and Day 42 | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens. |
| Duration of Solicited General AEs | Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A | Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | Day 0 up to Month 7 | For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs) | Day 0 up to Month 7 | pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Day 0 up to Month 7 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A | Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature \>39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6. | 20 |
| Influenza Vaccine GSK2186877A Formulation 2 Group Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Influenza Vaccine GSK2186877A Formulation 1 Group | Influenza Vaccine GSK2186877A Formulation 2 Group | Total |
|---|---|---|---|
| Age, Continuous | 23.2 Months STANDARD_DEVIATION 9.82 | 18.6 Months STANDARD_DEVIATION 7.46 | 20.90 Months STANDARD_DEVIATION 8.92 |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 20 | 18 / 20 |
| serious Total, serious adverse events | 0 / 20 | 3 / 20 |
Outcome results
Primary
Number of Subjects Reporting Fever Grade 2 or Higher
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Fever Grade 2 or Higher | 11 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Fever Grade 2 or Higher | 7 Participants |
Secondary
Duration of Solicited General AEs
Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Drowsiness [Dose 1] | 1.5 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Drowsiness [Dose 2] | 2.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Irritability [Dose 1] | 2.5 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Irritability [Dose 2] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Loss of appetite [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Loss of appetite [Dose 2] | 5.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Temperature [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Temperature [Dose 2] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Vomiting [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited General AEs | Vomiting [Dose 2] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Temperature [Dose 2] | NA Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Drowsiness [Dose 1] | 2.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Loss of appetite [Dose 2] | NA Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Drowsiness [Dose 2] | NA Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Vomiting [Dose 2] | NA Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Irritability [Dose 1] | 2.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Temperature [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Irritability [Dose 2] | NA Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Vomiting [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited General AEs | Loss of appetite [Dose 1] | 2.0 Days |
Secondary
Duration of Solicited Local AEs
Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited Local AEs | Swelling [Dose 2] | 3.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited Local AEs | Pain [Dose 2] | 2.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited Local AEs | Redness [Dose 2] | 2.5 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited Local AEs | Swelling [Dose 1] | 3.0 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited Local AEs | Redness [Dose 1] | 3.5 Days |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Duration of Solicited Local AEs | Pain [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited Local AEs | Swelling [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited Local AEs | Pain [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited Local AEs | Swelling [Dose 2] | NA Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited Local AEs | Redness [Dose 1] | 1.0 Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited Local AEs | Pain [Dose 2] | NA Days |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Duration of Solicited Local AEs | Redness [Dose 2] | NA Days |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Time frame: At Day 0 and Day 42
Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/CAL/7/09 H1N1 strain at Day 42 | 905.2 Titers |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/Uru/716/07 H3N2 strain at Day 42 | 722.5 Titers |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/CAL/7/09 H1N1 strain at Day 0 | 13.7 Titers |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Haemagglutination Inhibition (HI) Antibody Titers | FluB/Bri/60/08 Victoria strain at Day 0 | 5.9 Titers |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/Uru/716/07 H3N2 strain at Day 0 | 14.9 Titers |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Haemagglutination Inhibition (HI) Antibody Titers | FluB/Bri/60/08 Victoria strain at Day 42 | 460.5 Titers |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/Uru/716/07 H3N2 strain at Day 0 | 7.6 Titers |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/CAL/7/09 H1N1 strain at Day 0 | 35.4 Titers |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/CAL/7/09 H1N1 strain at Day 42 | 617.1 Titers |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Haemagglutination Inhibition (HI) Antibody Titers | FluB/Bri/60/08 Victoria strain at Day 42 | 63.1 Titers |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Haemagglutination Inhibition (HI) Antibody Titers | Flu A/Uru/716/07 H3N2 strain at Day 42 | 160.0 Titers |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Haemagglutination Inhibition (HI) Antibody Titers | FluB/Bri/60/08 Victoria strain at Day 0 | 5.9 Titers |
Secondary
HI Antibody Geometric Mean Fold Rise (GMFR)
GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Time frame: Day 42
Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) | Flu A/CAL/7/09 H1N1 strain | 66.3 fold change |
| Influenza Vaccine GSK2186877A Formulation 1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) | Flu A/Uru/716/07 H3N2 strain | 48.5 fold change |
| Influenza Vaccine GSK2186877A Formulation 1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) | FluB/Bri/60/08 Victoria strain | 77.4 fold change |
| Influenza Vaccine GSK2186877A Formulation 2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) | Flu A/CAL/7/09 H1N1 strain | 19.6 fold change |
| Influenza Vaccine GSK2186877A Formulation 2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) | Flu A/Uru/716/07 H3N2 strain | 20.7 fold change |
| Influenza Vaccine GSK2186877A Formulation 2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) | FluB/Bri/60/08 Victoria strain | 10.5 fold change |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 redness and swelling was \> 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 7 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 6 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 10 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 redness | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 pain | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any swelling | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any redness | 2 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Grade 3 swelling | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Any pain | 6 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0 up to Month 7
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE (s) | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE (s) | 3 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Day 0 up to Month 7
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | Any MAE(s) | 18 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | Grade 3 MAE(s) | 3 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | Related MAE(s) | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | Any MAE(s) | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | Grade 3 MAE(s) | 3 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) | Related MAE(s) | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature \>39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.
Time frame: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any drowsiness | 6 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related drowsiness | 3 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any irritability | 7 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 loss of appetite | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 irritability | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related irritability | 4 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any loss of appetite | 12 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 14 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 9 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any vomiting | 7 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 vomiting | 2 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related vomiting | 2 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 drowsiness | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related loss of appetite | 5 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 2 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 irritability | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any drowsiness | 7 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related temperature | 9 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related drowsiness | 3 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any vomiting | 4 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any irritability | 9 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related loss of appetite | 3 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any temperature | 12 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related vomiting | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Related irritability | 4 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 vomiting | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Any loss of appetite | 5 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 loss of appetite | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 drowsiness | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Grade 3 temperature | 1 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time frame: Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 14 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Any AE(s) | 12 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Grade 3 AE(s) | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs | Related AE(s) | 0 Participants |
Secondary
Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time frame: Day 0 up to Month 7
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs) | 0 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs) | 0 Participants |
Secondary
The Number of Subjects Seroconverted to HI Antibodies
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Time frame: Day 42
Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroconverted to HI Antibodies | Flu A/CAL/7/09 H1N1 strain | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroconverted to HI Antibodies | Flu A/Uru/716/07 H3N2 strain | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroconverted to HI Antibodies | FluB/Bri/60/08 Victoria strain | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroconverted to HI Antibodies | Flu A/CAL/7/09 H1N1 strain | 19 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroconverted to HI Antibodies | Flu A/Uru/716/07 H3N2 strain | 19 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroconverted to HI Antibodies | FluB/Bri/60/08 Victoria strain | 14 Participants |
Secondary
The Number of Subjects Seropositive to HI Antibodies
A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Time frame: At Day 0 and Day 42
Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 42 | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seropositive to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 42 | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 0 | 6 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seropositive to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 0 | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 42 | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 0 | 6 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 42 | 19 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 0 | 10 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 42 | 19 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seropositive to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 0 | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seropositive to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 42 | 19 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seropositive to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 0 | 2 Participants |
Secondary
The Number of Subjects Seroprotected to HI Antibodies
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
Time frame: At Day 0 and Day 42
Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 0 | 6 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 42 | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 0 | 6 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 42 | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroprotected to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 0 | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 1 Group | The Number of Subjects Seroprotected to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 42 | 20 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroprotected to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 0 | 1 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 0 | 10 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 42 | 19 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/CAL/7/09 H1N1 strain at Day 42 | 19 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroprotected to HI Antibodies | FluB/Bri/60/08 Victoria strain at Day 42 | 14 Participants |
| Influenza Vaccine GSK2186877A Formulation 2 Group | The Number of Subjects Seroprotected to HI Antibodies | Flu A/Uru/716/07 H3N2 strain at Day 0 | 2 Participants |