Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide · 1 trial · 1 indication
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.
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.
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.
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.
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
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.
Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| HBs-alum Group | ACTIVE_COMPARATOR | Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181. |
| HBs-AS03 Group | EXPERIMENTAL | Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31. |
| HBs-AS04 Group | EXPERIMENTAL | Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31. |
| HBs-AS37B Group | EXPERIMENTAL | Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31. |
| HBs-AS37A Group | EXPERIMENTAL | Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31. |
| Name | Type | Description |
|---|---|---|
| GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide | COMBINATION_PRODUCT | Three doses of GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide administered intramuscularly in the non-dominant arm, one each at Day 1, Day 31 and Day 181. |
| GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system | BIOLOGICAL | Two doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31. |
| GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system | BIOLOGICAL | Two doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31. |
| GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg) | BIOLOGICAL | Two doses of GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31. |
| GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg) | BIOLOGICAL | Two doses of GSK's HBsAg (20 μg )vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31. |
Inclusion Criteria: * Participants who the investigator believe can and will comply with the requirements of the protocol. * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Healthy participants as established by medical history, clinica...