A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY ADULTS 18 TO 49 YEARS OF AGE

Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade

时间窗: 1 week after vaccination

Hemoglobin:Grade(G)1: 11-13.5g/dL, G2:9.5-12.4g/dL,G3:8-10.4 g/dL, G4:\<8.0 g/dL; leukocyte increase:G1: 10.8-15\*10\^9/Liter\[L\],G2:\>15-20\*10\^9/L, G3:\>20-25\*10\^9/L, G4:\>25\*10\^9/L,leukocyte decrease: G1: 2.5-3.5\*10\^9/L, G2: 1.5-\<2.5\*10\^9/L, G3: 1-\<1.5\*10\^9/L, G4:\<1\*10\^9/L; neutrophil decrease:G1: 1.5-2\*10\^9/L, G2:1-\<1.5\*10\^9/L, G3:0.5-\<1\*10\^9/L,G4:\<0.5\*10\^9/L; platelets:G1: 125-140\*10\^9/L, G2:100-124\*10\^9/L, G3:25-99\*10\^9/L, G4:\<25\*10\^9/L; eosinophils: G1: 0.65-1.5\*10\^9/L, G2:\>1.5-5\*10\^9/L, G3:\>5\*10\^9/L, G4: hypereosinophilic;alanine aminotransferase,aspartate aminotransferase:G1: 1.1-2.5 \*ULN, G2:2.6-5.0\*ULN, G3:5.1-10\*ULN, G4:\>10\*ULN; alkaline phosphatase:G1: 1.1-2\*ULN, G2:2.1-3\*ULN, G3:3.1-10\*ULN, G4:\>10\*ULN; Bilirubin:G1: 1.1-1.5\*ULN, G2: 1.26-2\*ULN,G3: 1.51-3.0\*ULN,G4:\>1.75\*ULN;blood urea nitrogen:G1:23-26mg/dL,G2:27-31mg/dL,G3:\>31mg/dL, G4:dialysis;creatinine:G1:1.5-1.7mg/dL,G2:1.8-2mg/dL,G3:2.1-2.5 mg/dL,G4:dialysis.Categories with\>=1 participant with abnormality are reported only.

Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination

时间窗: Within 14 days after vaccination

Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter \[cm\]), moderate (greater than \[\>\] 5.0-10.0 cm) and severe (\>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: 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 which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.

Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination

时间窗: Within 14 days after vaccination

Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,\>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours\[hr\]),moderate(some interference with activity/\>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(\>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever \>24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

时间窗: Within 1 month after vaccination

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.

Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination

时间窗: Within 6 months after vaccination

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.

Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination

时间窗: Within 6 months after vaccination

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.