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

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.

Time frame: Within 1 month after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

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.

Time frame: 1 week after vaccination

Population: Analysis population for this outcome measure included a subset of participants who received GBS6 vaccine or placebo.

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.

Time frame: Within 14 days after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

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.

Time frame: Within 6 months after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

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.

Time frame: Within 6 months after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

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.

Time frame: Within 14 days after vaccination

Population: Safety population included all participants who received GBS6 vaccine or placebo.

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

Time frame: 1 month after vaccination

Population: Evaluable immunogenicity population included all eligible participants who received GBS6 vaccine or placebo, had 1 month after vaccination blood drawn for assay and had at least 1 valid determinate assay result with no major protocol violation. 'Number analyzed' = number of participants with valid, determinate assay results for specified serotype.