Trial Outcomes & Findings for A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction. (NCT NCT02075541)

NCT ID: NCT02075541

Last Updated: 2018-08-01

Results Overview

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

During a 7-day follow-up period (from Day 0 to Day 6) after first dose.

Results posted on

2018-08-01

Participant Flow

145 subjects, aged 40 to 80 years were recruited from 4 sites in Sweden and 11 sites in the United Kingdom.

All enrolled subjects were included in the study.

Participant milestones

Participant milestones
Measure	10-AS01E Group Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group Approximately 70 subjects who received 2 doses of placebo.
Overall Study STARTED	73	72
Overall Study COMPLETED	69	64
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	10-AS01E Group Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group Approximately 70 subjects who received 2 doses of placebo.
Overall Study Serious Adverse Event	1	4
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	1	3
Overall Study Sponsor study termination	0	1
Overall Study Other- unable to perform study procedure	1	0

Baseline Characteristics

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 Participants Approximately 70 subjects who received 2 doses of placebo.	Total n=145 Participants Total of all reporting groups
Age, Continuous	67 Years STANDARD_DEVIATION 8.41 • n=93 Participants	66.8 Years STANDARD_DEVIATION 7.21 • n=4 Participants	66.9 Years STANDARD_DEVIATION 7.81 • n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	36 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	36 Participants n=4 Participants	75 Participants n=27 Participants
Race/Ethnicity, Customized White- Caucasian/ European Heritage	73 Participants n=93 Participants	72 Participants n=4 Participants	145 Participants n=27 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (from Day 0 to Day 6) after first dose.

Population: Analysis was performed on the Total Vaccinated Cohort (TVC) that included all subjects with at least 1 study vaccine administration documented.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Any Solicited Local Adverse Events (AEs). Any Redness (mm)	9 Participants	0 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs). Any Swelling (mm)	4 Participants	0 Participants
Number of Subjects With Any Solicited Local Adverse Events (AEs). Any Pain	49 Participants	5 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (from Day 60 to Day 66) after second dose.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=69 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=68 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Any Solicited Local AEs. Any Pain	49 Participants	5 Participants
Number of Subjects With Any Solicited Local AEs. Any Redness (mm)	15 Participants	2 Participants
Number of Subjects With Any Solicited Local AEs. Any Swelling (mm)	8 Participants	0 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (from Day 0 to Day 6) following the first dose.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Any Solicited General AEs. Any Fatigue	21 Participants	19 Participants
Number of Subjects With Any Solicited General AEs. Any Gastrointestinal symptoms	12 Participants	10 Participants
Number of Subjects With Any Solicited General AEs. Any Headache	19 Participants	13 Participants
Number of Subjects With Any Solicited General AEs. Any Temperature/(Oral) (°C)	2 Participants	6 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (from Day 60 to Day 66) following the second dose.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever (defined as oral temperature equal to or above 37.5 °C). Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=69 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=68 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Any Solicited General AEs Any Fatigue	28 Participants	13 Participants
Number of Subjects With Any Solicited General AEs Any Gastrointestinal symptoms	15 Participants	6 Participants
Number of Subjects With Any Solicited General AEs Any Headache	20 Participants	13 Participants
Number of Subjects With Any Solicited General AEs Any Temperature/(Oral) (°C)	10 Participants	1 Participants

PRIMARY outcome

Timeframe: During the 30-day follow-up period (from Day 0 to Day 29) following the first dose.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Any Unsolicited AEs.	27 Participants	26 Participants

PRIMARY outcome

Timeframe: During the 30-day follow-up period (from Day 60 to Day 89) following the second dose.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Any Unsolicited AEs	25 Participants	22 Participants

PRIMARY outcome

Timeframe: At Day 0.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Assessed haematological parameters are complete blood cell count: Leukocytes \[white blood cells (WBC)\], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=70 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	15 Participants	9 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	7 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	0 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	6 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	6 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	2 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	12 Participants	9 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	5 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	4 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	10 Participants	8 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	1 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	5 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	3 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	1 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	12 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	2 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Day 7.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=69 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=67 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	0 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	9 Participants	7 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	4 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	1 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	4 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	8 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	5 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	4 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	4 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	1 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	2 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	15 Participants	12 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	5 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	12 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	1 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	7 Participants	10 Participants

PRIMARY outcome

Timeframe: At Day 30.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=68 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=68 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	1 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	3 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	14 Participants	11 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	3 Participants	8 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	10 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	5 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	8 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	14 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	7 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	8 Participants	10 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	1 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	9 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	3 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	1 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	6 Participants	12 Participants

PRIMARY outcome

Timeframe: At Day 60.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=70 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=69 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	3 Participants	8 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	5 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	0 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	7 Participants	12 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	1 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	4 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	3 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	1 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	12 Participants	11 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	4 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	1 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	8 Participants	7 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	13 Participants	9 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	4 Participants	8 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	7 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	5 Participants	8 Participants

PRIMARY outcome

Timeframe: At Day 67.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=65 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=64 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	11 Participants	8 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	4 Participants	12 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	0 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	4 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	5 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	6 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	2 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	5 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	16 Participants	11 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	6 Participants	11 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	8 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	5 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	3 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	5 Participants	9 Participants

PRIMARY outcome

Timeframe: At Day 90.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=72 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=69 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	10 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	5 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	1 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	4 Participants	10 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	3 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	5 Participants	8 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	11 Participants	10 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	6 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	0 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	3 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	7 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	1 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	13 Participants	13 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	10 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	2 Participants	2 Participants

PRIMARY outcome

Timeframe: At Day 270.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=67 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=65 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	10 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	1 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	5 Participants	10 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	7 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	5 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	5 Participants	2 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	1 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	4 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	11 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	7 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	10 Participants	9 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	1 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	9 Participants	11 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	13 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	9 Participants	9 Participants

PRIMARY outcome

Timeframe: At Day 450.

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=69 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=61 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC below	1 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. WBC above	3 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Basophils above	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Eosinophils above	6 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes below	0 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils above	7 Participants	4 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin below	6 Participants	10 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Haemoglobin above	10 Participants	6 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT above	3 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. AST above	1 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes below	17 Participants	9 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Lymphocytes above	8 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Monocytes above	6 Participants	5 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Neutrophils below	1 Participants	1 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets below	3 Participants	3 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Platelets above	14 Participants	13 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. ALT below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine below	0 Participants	0 Participants
Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality. Creatinine above	7 Participants	9 Participants

PRIMARY outcome

Timeframe: From first vaccination (Day 0) up to study conclusion (Day 450).

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs).	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From first vaccination (Day 0) up to study conclusion (Day 450).

Population: Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=73 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 Participants Approximately 70 subjects who received 2 doses of placebo.
Number of Subjects With Any Serious Adverse Events (SAEs).	15 Participants	17 Participants

SECONDARY outcome

Timeframe: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.

Population: Analysis was performed on the According to Protocol (ATP) cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.

Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay was 153 EL.U/mL for anti-PD.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=46 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=45 Participants Approximately 70 subjects who received 2 doses of placebo.
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. Anti-PD antibody, Day 30	840.1 EL.U/mL Interval 535.9 to 1317.0	102.6 EL.U/mL Interval 86.2 to 122.1
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. Anti-PD antibody, Day 60	538 EL.U/mL Interval 358.6 to 807.1	104.1 EL.U/mL Interval 87.6 to 123.6
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. Anti-PD antibody, Day 0	107.3 EL.U/mL Interval 87.9 to 130.9	100.3 EL.U/mL Interval 85.3 to 118.0
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. Anti-PD antibody, Day 90	1692.1 EL.U/mL Interval 1242.6 to 2304.0	103 EL.U/mL Interval 87.3 to 121.7
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. Anti-PD antibody, Day 270	598.3 EL.U/mL Interval 437.0 to 819.2	109.3 EL.U/mL Interval 90.9 to 131.4
Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens. Anti-PD antibody, Day 450	463 EL.U/mL Interval 340.4 to 629.8	108.4 EL.U/mL Interval 90.1 to 130.4

SECONDARY outcome

Timeframe: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450

Population: Analysis was performed on the ATP cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.

Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 8 EL.U/mL for anti-PE.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=46 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=44 Participants Approximately 70 subjects who received 2 doses of placebo.
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PE antobody, Day 270	1743.3 EL.U/mL Interval 1226.9 to 2477.0	12.6 EL.U/mL Interval 8.7 to 18.1
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PE antobody, Day 450	1247.5 EL.U/mL Interval 866.0 to 1797.0	13.6 EL.U/mL Interval 9.3 to 20.0
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PE antobody, Day 0	14.1 EL.U/mL Interval 9.5 to 21.0	14.8 EL.U/mL Interval 10.2 to 21.5
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PE antobody, Day 30	1007 EL.U/mL Interval 588.9 to 1722.0	13.6 EL.U/mL Interval 9.4 to 19.5
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PE antobody, Day 60	823.7 EL.U/mL Interval 503.3 to 1348.1	13.9 EL.U/mL Interval 9.7 to 19.9
Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PE antobody, Day 90	10953.4 EL.U/mL Interval 8414.9 to 14257.9	15 EL.U/mL Interval 10.3 to 21.9

SECONDARY outcome

Timeframe: At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.

Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 7 EL.U/mL for anti-PilA.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=46 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=43 Participants Approximately 70 subjects who received 2 doses of placebo.
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PilA antibody, Day 450	206.8 El.U/mL Interval 147.7 to 289.5	16.2 El.U/mL Interval 11.1 to 23.6
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PilA antibody, Day 0	12.3 El.U/mL Interval 8.6 to 17.6	14.5 El.U/mL Interval 10.2 to 20.5
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PilA antibody, Day 30	234.3 El.U/mL Interval 133.5 to 411.5	15.6 El.U/mL Interval 10.7 to 22.8
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PilA antibody, Day 60	207.5 El.U/mL Interval 122.4 to 351.6	15.1 El.U/mL Interval 10.7 to 21.3
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PilA antibody, Day 90	1353.7 El.U/mL Interval 989.7 to 1851.7	16.5 El.U/mL Interval 11.4 to 23.9
Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens. Anti-PilA antibody, Day 270	333.5 El.U/mL Interval 240.2 to 463.2	16.8 El.U/mL Interval 11.6 to 24.3

SECONDARY outcome

Timeframe: At Day 0, Day 90, Day 270 and at Day 450.

Population: Analysis was performed on a sub-cohort of participants from the ATP cohort for Immunogenicity, including approximately 40 subjects (20/each group), for which an additional blood sample was taken at the specified time points. The analysis was only performed on those subjects with available results for the analyzed outcome variable.

Frequency of specific CD4+ T-cells were measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers \[such as Interleukin-2 (IL-2), IL-13, IL-17, Interferon-γ (IFN-γ), Tumor Necrosis Factor-α (TNF-α) and Cluster of Differentiation 40 Ligand (CD40L)\].The frequency of specific CD4+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=15 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=9 Participants Approximately 70 subjects who received 2 doses of placebo.
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PD, Day 0	33.1 CD4+ T-cells/ million cells Standard Deviation 49.97	79.7 CD4+ T-cells/ million cells Standard Deviation 91.48
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PD, Day 270	189.6 CD4+ T-cells/ million cells Standard Deviation 146.87	51.8 CD4+ T-cells/ million cells Standard Deviation 59.4
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PilA, Day 90	474.4 CD4+ T-cells/ million cells Standard Deviation 321.58	37.4 CD4+ T-cells/ million cells Standard Deviation 46.53
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PilA, Day 270	145 CD4+ T-cells/ million cells Standard Deviation 164.58	80.3 CD4+ T-cells/ million cells Standard Deviation 95.6
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PD, Day 90	521.6 CD4+ T-cells/ million cells Standard Deviation 287.39	38.4 CD4+ T-cells/ million cells Standard Deviation 51.61
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PD, Day 450	148.6 CD4+ T-cells/ million cells Standard Deviation 141.11	97.8 CD4+ T-cells/ million cells Standard Deviation 98.4
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PE, Day 0	51.3 CD4+ T-cells/ million cells Standard Deviation 68.72	69.1 CD4+ T-cells/ million cells Standard Deviation 82.87
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PE, Day 90	857.9 CD4+ T-cells/ million cells Standard Deviation 642.76	65 CD4+ T-cells/ million cells Standard Deviation 92.86
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PE, Day 270	304.4 CD4+ T-cells/ million cells Standard Deviation 292.46	71.6 CD4+ T-cells/ million cells Standard Deviation 90.51
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PE, Day 450	337.2 CD4+ T-cells/ million cells Standard Deviation 302.42	117.8 CD4+ T-cells/ million cells Standard Deviation 53.24
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PilA, Day 0	29.7 CD4+ T-cells/ million cells Standard Deviation 53.21	98.3 CD4+ T-cells/ million cells Standard Deviation 74.27
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD4+ T-cells, PilA, Day 450	157.7 CD4+ T-cells/ million cells Standard Deviation 117.76	102.8 CD4+ T-cells/ million cells Standard Deviation 116.48

SECONDARY outcome

Timeframe: At Day 0, Day 90, Day 270 and at Day 450.

Frequency of specific CD8+ T-cells were measured by flow cytometry ICS expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L).The frequency of specific CD8+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.

Outcome measures

Outcome measures
Measure	10-AS01E Group n=14 Participants Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=9 Participants Approximately 70 subjects who received 2 doses of placebo.
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PD, Day 90	39.6 CD8+ T-cells/ million cells Standard Deviation 73.78	45.8 CD8+ T-cells/ million cells Standard Deviation 77.53
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PD, Day 450	51.5 CD8+ T-cells/ million cells Standard Deviation 60.19	16.2 CD8+ T-cells/ million cells Standard Deviation 24.04
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PE, Day 270	29.9 CD8+ T-cells/ million cells Standard Deviation 57.16	60.3 CD8+ T-cells/ million cells Standard Deviation 83.47
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PilA, Day 0	63.1 CD8+ T-cells/ million cells Standard Deviation 122.12	23.1 CD8+ T-cells/ million cells Standard Deviation 45.92
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PilA, Day 270	27.4 CD8+ T-cells/ million cells Standard Deviation 34.15	13 CD8+ T-cells/ million cells Standard Deviation 15.12
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PD, Day 0	97.1 CD8+ T-cells/ million cells Standard Deviation 186.24	47.9 CD8+ T-cells/ million cells Standard Deviation 72.9
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PD, Day 270	55.3 CD8+ T-cells/ million cells Standard Deviation 59.18	48.7 CD8+ T-cells/ million cells Standard Deviation 56.33
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PE, Day 0	97.7 CD8+ T-cells/ million cells Standard Deviation 204.06	73.9 CD8+ T-cells/ million cells Standard Deviation 131.71
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PE, Day 90	44.9 CD8+ T-cells/ million cells Standard Deviation 47.72	30.6 CD8+ T-cells/ million cells Standard Deviation 59.01
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PE, Day 450	41 CD8+ T-cells/ million cells Standard Deviation 74.41	31.6 CD8+ T-cells/ million cells Standard Deviation 43.34
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PilA, Day 90	39.7 CD8+ T-cells/ million cells Standard Deviation 73.42	80.3 CD8+ T-cells/ million cells Standard Deviation 125.84
Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response. CD8+ T-cells, PilA, Day 450	63.7 CD8+ T-cells/ million cells Standard Deviation 98.87	31 CD8+ T-cells/ million cells Standard Deviation 36.17

Adverse Events

10-AS01E Group

Serious events: 15 serious events

Other events: 65 other events

Deaths: 1 deaths

Control Group

Serious events: 17 serious events

Other events: 42 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	10-AS01E Group n=73 participants at risk Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 participants at risk Approximately 70 subjects who received 2 doses of placebo.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 5/73 • Number of events 5 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
General disorders Fatigue	50.7% 37/73 • Number of events 51 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	31.9% 23/72 • Number of events 32 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Gastrointestinal disorders Gastrointestinal disorder	30.1% 22/73 • Number of events 27 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	20.8% 15/72 • Number of events 16 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Nervous system disorders Headache	41.1% 30/73 • Number of events 42 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	30.6% 22/72 • Number of events 34 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
General disorders Injection site erythema	26.0% 19/73 • Number of events 26 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	2.8% 2/72 • Number of events 2 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
General disorders Injection site pain	80.8% 59/73 • Number of events 98 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	12.5% 9/72 • Number of events 10 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
General disorders Injection site swelling	12.3% 9/73 • Number of events 12 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Nasopharyngitis	9.6% 7/73 • Number of events 7 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	5.6% 4/72 • Number of events 4 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.8% 5/73 • Number of events 5 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	6.9% 5/72 • Number of events 6 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
General disorders Pyrexia	13.7% 10/73 • Number of events 12 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	9.7% 7/72 • Number of events 7 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Urinary tract infection	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	5.6% 4/72 • Number of events 4 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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

Measure	10-AS01E Group n=73 participants at risk Approximately 70 subjects who received 2 doses of the investigational NTHi vaccine.	Control Group n=72 participants at risk Approximately 70 subjects who received 2 doses of placebo.
Cardiac disorders Atrial fibrillation	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Cardiac disorders Bradycardia	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Cardiac disorders Cardiac failure	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Cardiac disorders Dressler's syndrome	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Cardiac disorders Myocardial infarction	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	2.8% 2/72 • Number of events 2 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Gastrointestinal disorders Constipation	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
General disorders Non-cardiac chest pain	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
General disorders Systemic inflammatory response syndrome	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Hepatobiliary disorders Cholecystitis	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Bronchitis viral	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Cellulitis	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Gastroenteritis viral	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	2.7% 2/73 • Number of events 3 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	2.8% 2/72 • Number of events 2 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Lower respiratory tract infection	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Pneumonia	2.7% 2/73 • Number of events 2 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	2.8% 2/72 • Number of events 2 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Pyelonephritis	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Infections and infestations Tooth abscess	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Injury, poisoning and procedural complications Rib fracture	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Nervous system disorders Dementia	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Nervous system disorders Facial paralysis	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Psychiatric disorders Suicidal ideation	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	5.5% 4/73 • Number of events 6 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	13.9% 10/72 • Number of events 14 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/73 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	1.4% 1/72 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.
Vascular disorders Haematoma	1.4% 1/73 • Number of events 1 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.	0.00% 0/72 • Solicted AEs: during the 7-day interval post each vaccine dose, Unsolicited AEs: during the 30-day interval post each vaccine dose, SAEs: throughout the entire study, from Day 0 up to Day 450.