Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was \>20 mm for ecchymosis, redness and swelling.

Duration was defined as number of days with any grade of local symptoms.

Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.

Duration was defined as number of days with any grade of general symptoms.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.

For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.

AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.