Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.

Serious adverse events (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. Related = SAE assessed by the investigator as causally related to the study vaccination.

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).

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 = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.

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 SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.