Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

GMCs of anti-PT, anti-FHA, and anti-PRN was reported as descriptive data for the GBS6 +Tdap and placebo + Tdap groups, along with associated 2-sided 95% confidence interval. GMR for anti-PT, anti-FHA and anti-PRN antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

Time frame: 1 Month after Vaccination (Day 1, day of vaccination)

Population: Evaluable immunogenicity population included all participants who were eligible, received all doses of the investigational products to which they were randomized, had blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month postvaccination visit, and had no major protocol violations.

GBS CPS serotype-specific IgG GMCs (Ia, Ib, II, III, IV, V) were reported as descriptive data for the GBS6+Tdap and GBS6+placebo groups, along with associated 2-sided 95% confidence interval. GMR of GBS CPS serotype-specific IgG antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

Time frame: 1 Month after Vaccination (Day 1, day of vaccination)

Population: Evaluable immunogenicity population evaluated. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. Here, Number analyzed signifies number of participants with valid and determinate assay results for the serotype at the specified time point.

IU/mL stands for international units per milliliter.

Time frame: 1 Month after Vaccination (Day 1, day of vaccination)

Population: Evaluable immunogenicity population included all participants who were eligible, received all doses of the investigational products to which they were randomized, had blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month postvaccination visit, and had no major protocol violations.

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. In this outcome measure results excluded data for local reactions and systemic events.

Time frame: Day 1 (day of vaccination) through 1 Month post-vaccination

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment.

Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.0 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

Time frame: Day 1 (day of vaccination) to Day 7

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

Time frame: Day 1 (day of vaccination) through 6 Months post-vaccination

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment.

Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, chills, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

Time frame: Day 1 (day of vaccination) to Day 7

Population: Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment.