Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2321138A Group | Experimental | Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm. |
|
| Fluarix Group | Active Comparator | Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine GSK2321138A | Biological | Intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables. | At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST] |
| Measure | Description | Time Frame |
|---|---|---|
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. |
Not provided
Inclusion Criteria:
For all subjects:
For unprimed subjects:
For primed subjects from study NCT00764790:
• Children who received Fluarix™ in the 111751 study NCT00764790.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ecatepec de Morelos | State of Mexico | 55075 | Mexico | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25386965 | Derived | Rodriguez Weber MA, Claeys C, Aranza Doniz C, Feng Y, Innis BL, Jain VK, Peeters M. Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age. Pediatr Infect Dis J. 2014 Dec;33(12):1262-9. doi: 10.1097/INF.0000000000000463. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113237 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
For demography and safety, results are presented as per the main study groups. For some outcome measures and where relevant, subjects as in these 2 main groups are split according to their priming status at study entry.
A total of 599 subjects were enrolled in the study, and assigned to either the GSK2321138A Group (298 subjects) or the Fluarix Group (301 subjects). Duration of study was of approximately 6 months for each subject.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSK2321138A Group | Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm. |
| FG001 | Fluarix Group | Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK2321138A Group | Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains. | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST] |
|
SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2321138A Group | Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C510903 | fluarix |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluarix™ |
| Biological |
Intramuscular injection |
|
| At Days 0 and 28. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | At Days 0, 28 and Day 56 |
| Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | At Days 0 and 28 |
| Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | At Days 0, 28 and 56 |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | At Day 28 |
| Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | At Days 28 and 56 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | At Day 28 |
| Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | At Days 28 and 56 |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | At Days 0 and 28 |
| Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | At Days 0, 28 and 56 |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 7-day follow-up period (Days 0 to 6) after any vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C. | During the 7-day follow-up period (Days 0 to 6) after any vaccination |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination. | During the 28-day follow-up period (Days 0 to 27) after vaccination |
| Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination. | From Day 0 to Day 180 (study conclusion) |
| Number of Subjects With Any Adverse Events of Specific Interest (AESIs). | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | From Day 0 to Day 180 (study conclusion) |
| Mexico City |
| 04530 |
| Mexico |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113237 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113237 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113237 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113237 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113237 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 | Fluarix Group | Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Fluarix Group | Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm. |
|
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Days 0 and 28. |
|
|
|
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Days 0, 28 and Day 56 |
|
|
|
| Secondary | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Count of Participants | Participants | At Days 0 and 28 |
|
|
|
| Secondary | Number of Seropositive Subjects Against 4 Strains of Influenza Disease. | A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Count of Participants | Participants | At Days 0, 28 and 56 |
|
|
|
| Secondary | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Count of Participants | Participants | At Day 28 |
|
|
|
| Secondary | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination 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. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Count of Participants | Participants | At Days 28 and 56 |
|
|
|
| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At Day 28 |
|
|
|
| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At Days 28 and 56 |
|
|
|
| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Count of Participants | Participants | At Days 0 and 28 |
|
|
|
| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination. | Posted | Count of Participants | Participants | At Days 0, 28 and 56 |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed. | Posted | Count of Participants | Participants | During the 7-day follow-up period (Days 0 to 6) after any vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed. | Posted | Count of Participants | Participants | During the 7-day follow-up period (Days 0 to 6) after any vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During the 28-day follow-up period (Days 0 to 27) after vaccination |
|
|
|
| Secondary | Number of Subjects With Any and Related Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 to Day 180 (study conclusion) |
|
|
|
| Secondary | Number of Subjects With Any Adverse Events of Specific Interest (AESIs). | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 0 to Day 180 (study conclusion) |
|
|
|
| 0 |
| 298 |
| 230 |
| 298 |
| EG001 | Fluarix Group | Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm. | 2 | 301 | 221 | 301 |
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Temperature | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
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.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| H3N2, Day 0 |
|
| H3N2, Day 28 |
|
| VICT, Day 0 |
|
| VICT, Day 28 |
|
| YAMA, Day 0 |
|
| YAMA, Day 28 |
|
| H1N1, Day 28 |
|
|
| H1N1, Day 56 |
|
|
| H3N2, Day 0 |
|
|
| H3N2, Day 28 |
|
|
| H3N2, Day 56 |
|
|
| VICT, Day 0 |
|
|
| VICT, Day 28 |
|
|
| VICT, Day 56 |
|
|
| YAMA, Day 0 |
|
|
| YAMA, Day 28 |
|
|
| YAMA, Day 56 |
|
|
| H3N2, Day 0 |
|
| H3N2, Day 28 |
|
| VICT, Day 0 |
|
| VICT, Day 28 |
|
| YAMA, Day 0 |
|
| YAMA, Day 28 |
|
| H1N1, Day 28 |
|
|
| H1N1, Day 56 |
|
|
| H3N2, Day 0 |
|
|
| H3N2, Day 28 |
|
|
| H3N2, Day 56 |
|
|
| VICT, Day 0 |
|
|
| VICT, Day 28 |
|
|
| VICT, Day 56 |
|
|
| YAMA, Day 0 |
|
|
| YAMA, Day 28 |
|
|
| YAMA, Day 56 |
|
|
| VICT, Day 28 |
|
| YAMA, Day 28 |
|
| H1N1, Day 56 |
|
|
| H3N2, Day 28 |
|
|
| H3N2, Day 56 |
|
|
| VICT, Day 28 |
|
|
| VICT, Day 56 |
|
|
| YAMA, Day 28 |
|
|
| YAMA, Day 56 |
|
|
| VICT, Day 28 |
|
| YAMA, Day 28 |
|
| H1N1, Day 56 |
|
|
| H3N2, Day 28 |
|
|
| H3N2, Day 56 |
|
|
| VICT, Day 28 |
|
|
| VICT, Day 56 |
|
|
| YAMA, Day 28 |
|
|
| YAMA, Day 56 |
|
|
| H3N2, Day 0 |
|
| H3N2, Day 28 |
|
| VICT, Day 0 |
|
| VICT, Day 28 |
|
| YAMA, Day 0 |
|
| YAMA, Day 28 |
|
| H1N1, Day 28 |
|
|
| H1N1, Day 56 |
|
|
| H3N2, Day 0 |
|
|
| H3N2, Day 28 |
|
|
| H3N2, Day 56 |
|
|
| VICT, Day 0 |
|
|
| VICT, Day 28 |
|
|
| VICT, Day 56 |
|
|
| YAMA, Day 0 |
|
|
| YAMA, Day 28 |
|
|
| YAMA, Day 56 |
|
|
| Any Redness |
|
| Redness >50 mm |
|
| Any Swelling |
|
| Swelling >50 mm |
|
| Related Drowsiness |
|
| Any Irritability |
|
| Grade 3 Irritability |
|
| Related Irritability |
|
| Any Loss of appetite |
|
| Grade 3 Loss of appetite |
|
| Related Loss of appetite |
|
| Temperature ≥ 37.5°C |
|
| Temperature > 39.0°C |
|
| Related Temperature |
|
| Subjects with related AE(s) |
|