Trial Outcomes & Findings for Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children (NCT NCT01096056)
NCT ID: NCT01096056
Last Updated: 2018-09-24
Results Overview
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Results posted on
2018-09-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
Completed at Day 42
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children
Baseline characteristics by cohort
| Measure |
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.2 Months
STANDARD_DEVIATION 9.82 • n=5 Participants
|
18.6 Months
STANDARD_DEVIATION 7.46 • n=7 Participants
|
20.90 Months
STANDARD_DEVIATION 8.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877APopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Fever Grade 2 or Higher
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers
Flu A/CAL/7/09 H1N1 strain at Day 0
|
35.4 Titers
Interval 13.6 to 92.6
|
13.7 Titers
Interval 6.5 to 28.9
|
|
Haemagglutination Inhibition (HI) Antibody Titers
Flu A/CAL/7/09 H1N1 strain at Day 42
|
617.1 Titers
Interval 251.0 to 1516.8
|
905.2 Titers
Interval 649.0 to 1262.6
|
|
Haemagglutination Inhibition (HI) Antibody Titers
Flu A/Uru/716/07 H3N2 strain at Day 0
|
7.6 Titers
Interval 4.1 to 13.9
|
14.9 Titers
Interval 6.6 to 33.5
|
|
Haemagglutination Inhibition (HI) Antibody Titers
Flu A/Uru/716/07 H3N2 strain at Day 42
|
160.0 Titers
Interval 86.3 to 296.7
|
722.5 Titers
Interval 473.8 to 1101.7
|
|
Haemagglutination Inhibition (HI) Antibody Titers
FluB/Bri/60/08 Victoria strain at Day 0
|
5.9 Titers
Interval 4.1 to 8.5
|
5.9 Titers
Interval 4.1 to 8.5
|
|
Haemagglutination Inhibition (HI) Antibody Titers
FluB/Bri/60/08 Victoria strain at Day 42
|
63.1 Titers
Interval 30.9 to 128.8
|
460.5 Titers
Interval 320.4 to 661.8
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
The Number of Subjects Seropositive to HI Antibodies
Flu A/CAL/7/09 H1N1 strain at Day 42
|
19 Participants
|
20 Participants
|
|
The Number of Subjects Seropositive to HI Antibodies
Flu A/Uru/716/07 H3N2 strain at Day 0
|
2 Participants
|
6 Participants
|
|
The Number of Subjects Seropositive to HI Antibodies
Flu A/Uru/716/07 H3N2 strain at Day 42
|
19 Participants
|
20 Participants
|
|
The Number of Subjects Seropositive to HI Antibodies
FluB/Bri/60/08 Victoria strain at Day 0
|
1 Participants
|
1 Participants
|
|
The Number of Subjects Seropositive to HI Antibodies
Flu A/CAL/7/09 H1N1 strain at Day 0
|
10 Participants
|
6 Participants
|
|
The Number of Subjects Seropositive to HI Antibodies
FluB/Bri/60/08 Victoria strain at Day 42
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
The Number of Subjects Seroprotected to HI Antibodies
FluB/Bri/60/08 Victoria strain at Day 0
|
1 Participants
|
1 Participants
|
|
The Number of Subjects Seroprotected to HI Antibodies
Flu A/CAL/7/09 H1N1 strain at Day 0
|
10 Participants
|
6 Participants
|
|
The Number of Subjects Seroprotected to HI Antibodies
Flu A/CAL/7/09 H1N1 strain at Day 42
|
19 Participants
|
20 Participants
|
|
The Number of Subjects Seroprotected to HI Antibodies
Flu A/Uru/716/07 H3N2 strain at Day 0
|
2 Participants
|
6 Participants
|
|
The Number of Subjects Seroprotected to HI Antibodies
Flu A/Uru/716/07 H3N2 strain at Day 42
|
19 Participants
|
20 Participants
|
|
The Number of Subjects Seroprotected to HI Antibodies
FluB/Bri/60/08 Victoria strain at Day 42
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 42Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=19 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
The Number of Subjects Seroconverted to HI Antibodies
Flu A/CAL/7/09 H1N1 strain
|
19 Participants
|
20 Participants
|
|
The Number of Subjects Seroconverted to HI Antibodies
Flu A/Uru/716/07 H3N2 strain
|
19 Participants
|
20 Participants
|
|
The Number of Subjects Seroconverted to HI Antibodies
FluB/Bri/60/08 Victoria strain
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 42Population: The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=19 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
HI Antibody Geometric Mean Fold Rise (GMFR)
Flu A/CAL/7/09 H1N1 strain
|
19.6 fold change
Interval 13.4 to 28.5
|
66.3 fold change
Interval 38.8 to 113.3
|
|
HI Antibody Geometric Mean Fold Rise (GMFR)
Flu A/Uru/716/07 H3N2 strain
|
20.7 fold change
Interval 14.8 to 28.8
|
48.5 fold change
Interval 28.0 to 84.1
|
|
HI Antibody Geometric Mean Fold Rise (GMFR)
FluB/Bri/60/08 Victoria strain
|
10.5 fold change
Interval 6.3 to 17.6
|
77.4 fold change
Interval 59.4 to 101.0
|
SECONDARY outcome
Timeframe: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877APopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any pain
|
6 Participants
|
10 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 pain
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any redness
|
2 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 redness
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any swelling
|
1 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 swelling
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877APopulation: 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.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=6 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=7 Participants
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.
|
|---|---|---|
|
Duration of Solicited Local AEs
Pain [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
2.0 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local AEs
Redness [Dose 1]
|
1.0 Days
Interval 1.0 to 1.0
|
3.5 Days
Interval 2.0 to 5.0
|
|
Duration of Solicited Local AEs
Redness [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
2.5 Days
Interval 2.0 to 3.0
|
|
Duration of Solicited Local AEs
Swelling [Dose 1]
|
1.0 Days
Interval 1.0 to 1.0
|
3.0 Days
Interval 3.0 to 3.0
|
|
Duration of Solicited Local AEs
Swelling [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
3.0 Days
Interval 2.0 to 4.0
|
|
Duration of Solicited Local AEs
Pain [Dose 1]
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877APopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 temperature
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any drowsiness
|
7 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 drowsiness
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related drowsiness
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any irritability
|
9 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 irritability
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related irritability
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related loss of appetite
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature
|
12 Participants
|
14 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related temperature
|
9 Participants
|
9 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any vomiting
|
4 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 vomiting
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related vomiting
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any loss of appetite
|
5 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 loss of appetite
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877APopulation: 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.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=12 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=9 Participants
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.
|
|---|---|---|
|
Duration of Solicited General AEs
Drowsiness [Dose 1]
|
2.0 Days
Interval 1.0 to 6.0
|
1.5 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited General AEs
Drowsiness [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited General AEs
Irritability [Dose 1]
|
2.0 Days
Interval 1.0 to 6.0
|
2.5 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited General AEs
Irritability [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited General AEs
Loss of appetite [Dose 1]
|
2.0 Days
Interval 1.0 to 4.0
|
1.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited General AEs
Loss of appetite [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
5.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited General AEs
Temperature [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
1.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited General AEs
Vomiting [Dose 1]
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Duration of Solicited General AEs
Vomiting [Dose 2]
|
NA Days
Subjects did not receive any second vaccine dose, as per protocol.
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited General AEs
Temperature [Dose 1]
|
1.0 Days
Interval 1.0 to 6.0
|
1.0 Days
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Within 21 days after any vaccination with New generation influenza vaccine GSK2186877APopulation: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Grade 3 AE(s)
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Related AE(s)
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Any AE(s)
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 0 up to Month 7Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
Any MAE(s)
|
20 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
Grade 3 MAE(s)
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)
Related MAE(s)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 up to Month 7Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 up to Month 7Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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.
Outcome measures
| Measure |
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 Participants
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.
|
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE (s)
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Participants
|
0 Participants
|
Adverse Events
Influenza Vaccine GSK2186877A Formulation 1 Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Influenza Vaccine GSK2186877A Formulation 2 Group
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 participants at risk
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.
|
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
Other adverse events
| Measure |
Influenza Vaccine GSK2186877A Formulation 1 Group
n=20 participants at risk
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.
|
Influenza Vaccine GSK2186877A Formulation 2 Group
n=20 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
50.0%
10/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
30.0%
6/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Redness
|
35.0%
7/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
10.0%
2/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Swelling
|
30.0%
6/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Drowsiness
|
30.0%
6/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
35.0%
7/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Irritability
|
35.0%
7/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
45.0%
9/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Loss of appetite
|
60.0%
12/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
25.0%
5/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Temperature
|
70.0%
14/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
60.0%
12/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Vomiting
|
35.0%
7/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
20.0%
4/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
5/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
35.0%
7/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
General disorders
Pyrexia
|
25.0%
5/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
10.0%
2/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Otitis media acute
|
15.0%
3/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
10.0%
2/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
10.0%
2/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
2/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Gastrointestinal disorders
Teething
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
10.0%
2/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Infections and infestations
Tonsillitis
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
|
Vascular disorders
Haematoma
|
0.00%
0/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
5.0%
1/20 • Serious adverse events were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER