GVGH S. sonnei vaccine 25 μg

Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature \> 40.0 °C.

An unsolicited AE is an AE that was not solicited using the Diary Card and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Note: \*disruptions= dose reduction, interruption or delay in study vaccination.

An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions); congenital anomaly/or birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.

The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). 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 safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). 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 safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). 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 safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). 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.

Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed "reactive". Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine.