Local reactions were collected by using an e-diary and included pain at injection site, redness, and swelling graded below: pain at injection site: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity), grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.0-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm),severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis).Maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.

All the participants reporting "yes" or "no" for at least 1 day were included in the analysis.

Nausea/Vomiting:Mild:No interference with activity or 1-2 times in 24 hours;Moderate:Some interference with activity or>2 times in 24 hours;Severe:Prevented daily activity, required IV hydration.Diarrhea:Mild:2-3 loose stools in 24 hours;Moderate: 4-5 loose stools in 24 hours;Severe:>=6 loose stools in 24 hours.Headache:Mild:No interference with activity;Moderate:Repeated use of nonnarcotic pain reliever >24 hours or some interference with activity;Severe:Significant; any use of narcotic pain reliever or prevents daily activity.Fatigue:Mild:No interference with activity;Moderate: Some interference with activity;Severe: Significant; prevented daily activity.Muscle pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant;prevented daily activity.Muscle/joint pain:Mild: No interference with activity;Moderate:Some interference with activity;Severe:Significant; prevented daily activity.Grade 4 for all AEs:Emergency visit or hospitalization.

All the participants reporting "yes" or "no" for at least 1 day were included in the analysis.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.

Safety population included all participants who received 1 booster dose and had at least 1 safety assessment after receiving the booster dose.

An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.

Safety population included all participants who received 1 booster dose and had at least 1 safety assessment after receiving the booster dose.

An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

Safety population included all participants who received the booster dose.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.

OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.

Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.

IgG for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.

Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.

OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample at Day 1 and at 1 month after booster dose.

Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. The pre-vaccination immunogenicity blood draw and booster vaccination were both performed on Day 1.

Evaluable immunogenicity population included participants who had received 1 booster dose (as assigned); had a Visit 2 blood draw within 27 to 45 days after booster dose administration; had at least 1 valid and determinate assay result at Visit 2; and had no major protocol violation.