Trial Outcomes & Findings for Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children (NCT NCT01195779)

Results Overview

Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

at Day 28/ Day 56

Results posted on

2020-10-30

Participant Flow

Since this study was prematurely terminated (not because of safety issues or lack of immunogenicity but for logistic reasons) only 4 of 1120 planned subjects were enrolled.

Participant milestones

Participant milestones
Measure	GSK2584786A Vaccine 1 Dose of Formulation A3 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.	GSK2584786A Vaccine 2 Doses of Formulation B1 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.	GSK2584786A Vaccine 2 Doses of Formulation B3 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.	Fluarix Group Subjects received 2 doses of Fluarix Vaccine.
Overall Study STARTED	1	1	1	1
Overall Study COMPLETED	1	1	1	1
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2584786A Vaccine 1 Dose of Formulation A1 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.	GSK2584786A Vaccine 2 Doses of Formulation A1 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.	GSK2584786A Vaccine 1 Dose of Formulation A2 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.	GSK2584786A Vaccine 2 Doses of Formulation A2 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.	GSK2584786A Vaccine 1 Dose of Formulation A3 Group n=1 Participants Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.	GSK2584786A Vaccine 2 Doses of Formulation A3 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.	GSK2584786A Vaccine 1 Dose of Formulation B1 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.	GSK2584786A Vaccine 2 Doses of Formulation B1 Group n=1 Participants Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.	GSK2584786A Vaccine 1 Dose of Formulation B2 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.	GSK2584786A Vaccine 2 Doses of Formulation B2 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.	GSK2584786A Vaccine 1 Dose of Formulation B3 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.	GSK2584786A Vaccine 2 Doses of Formulation B3 Group n=1 Participants Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.	GSK2321138A Vaccine Group Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).	Fluarix Group n=1 Participants Subjects received 2 doses of Fluarix Vaccine.	Total n=4 Participants Total of all reporting groups
Age, Continuous Months	—	—	—	—	28 Months STANDARD_DEVIATION NA • n=21 Participants	—	—	17 Months STANDARD_DEVIATION NA • n=24 Participants	—	—	—	14 Months STANDARD_DEVIATION NA • n=42 Participants	—	14 Months STANDARD_DEVIATION NA • n=36 Participants	18.25 Months STANDARD_DEVIATION 6.65 • n=24 Participants
Sex: Female, Male Female	—	—	—	—	0 Participants n=21 Participants	—	—	1 Participants n=24 Participants	—	—	—	0 Participants n=42 Participants	—	1 Participants n=36 Participants	2 Participants n=24 Participants
Sex: Female, Male Male	—	—	—	—	1 Participants n=21 Participants	—	—	0 Participants n=24 Participants	—	—	—	1 Participants n=42 Participants	—	0 Participants n=36 Participants	2 Participants n=24 Participants

PRIMARY outcome

Timeframe: at Day 28/ Day 56

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at Day 28/ Day 56

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: at Day 28/ Day 56

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Geometric mean of the number of CD4 cytokine positive T cells per million T cells.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: on Days 0, 28/56 and 180

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: on Days 0, 28/56 and 180

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during a 7 day follow-up period (Day 0 to 6) after any vaccination

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 28 days (Day 0 to Day 27) after any vaccination

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.

Outcome measures

Outcome measures
Measure	GSK2584786A Vaccine 1 Dose of Formulation A1 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.	GSK2584786A Vaccine 2 Doses of Formulation A1 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.	GSK2584786A Vaccine 1 Dose of Formulation A2 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.	GSK2584786A Vaccine 2 Doses of Formulation A2 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.	GSK2584786A Vaccine 1 Dose of Formulation A3 Group n=1 Participants Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.	GSK2584786A Vaccine 2 Doses of Formulation A3 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.	GSK2584786A Vaccine 1 Dose of Formulation B1 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.	GSK2584786A Vaccine 2 Doses of Formulation B1 Group n=1 Participants Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.	GSK2584786A Vaccine 1 Dose of Formulation B2 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.	GSK2584786A Vaccine 2 Doses of Formulation B2 Group Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.	GSK2584786A Vaccine 1 Dose of Formulation B3 Group Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.	GSK2584786A Vaccine 2 Doses of Formulation B3 Group n=1 Participants Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.	GSK2321138A Vaccine Group Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).	Fluarix Group n=1 Participants Subjects received 2 doses of Fluarix Vaccine.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	—	—	—	—	0 Subjects	—	—	1 Subjects	—	—	—	1 Subjects	—	1 Subjects

SECONDARY outcome

Timeframe: From Day 0 to 179

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 0 to 179

Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.

Potential Immune-Mediated Diseases (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

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 0 to 179

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.