Assessed solicited administration site events after vaccination included erythema, pain, and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention. Only participants with solicited administration site events diary card available after dose 1 administration for the specified duration were included in this analysis.

Assessed solicited administration site events after vaccination included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.

The analysis was performed on the ES. Only participants with solicited administration site events diary card available after dose 2 administration for the specified duration were included in this analysis.

Assessed solicited systemic events included fever (defined as temperature greater than or equal to (>=) 38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.

The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 1 administration for the specified duration were included in this analysis.

Assessed solicited systemic events included fever (defined as temperature >=38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.

The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 2 administration for the specified duration were included in this analysis.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 1.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 2.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 1.

Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.

The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 2.

An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

The analysis was performed on the ES. Only participants with unsolicited AEs after dose 1 administration for the specified duration were included in this analysis.

Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.

The analysis was performed on the ES. Only participants with unsolicited AEs after dose 2 administration for the specified duration were included in this analysis.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is an abnormal pregnancy outcome. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.

The analysis was performed on the ES.

An MAE is any AE with medically attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the MAE regardless of intensity grade or relation to the study vaccination.

The analysis was performed on the ES.

An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.

The analysis was performed on the ES.

pIMDs are a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination.

The analysis was performed on the ES.

In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).

The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 1 administration were available for the specified timepoint (at Day 8) were included in analysis.

In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.

The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 1 administration were available for the specified timepoint (at Day 31) were included in analysis.

In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.

The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 2 administration were available for the specified timepoint (at Day 38) were included in analysis.

In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.

The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 2 administration were available for the specified timepoint (at Day 61) were included in analysis.

Anti-HBs antibody concentration was measured as GMC and expressed in milli international units per milliliter (mIU/mL).

The analysis was performed on the Per-Protocol set (PPS), which included all participants who received all doses as per protocol, had immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available for GMC of anti-HBs antibody concentration at the specified timepoints were included in the analysis.

A participant who seroconverted for anti-HBs is defined as a participant with an anti-HBs antibody concentration higher than (>) 6.2 mIU/mL.

The analysis was performed on the PPS. Only participants that seroconverted for anti-HBs and had data available at the specified timepoints were included in the analysis.

A participant seroprotected for anti-HBs is defined as a participant with an anti-HBs antibody concentration >10 mIU/mL.

The analysis was performed on the PPS. Only participants that were seroprotected for anti-HBs and had data available at the specified timepoints were included in the analysis.

In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 1) were included in analysis.

In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 8) were included in analysis.

In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 31) were included in analysis.

In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 38) were included in analysis.

In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 61) were included in analysis.