Group B Streptococcus Infections
Conditions
Brief summary
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
Interventions
Various formulations at three dose levels
BIOLOGICALPlacebo
Saline control
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.
Eligibility
Sex/Gender
ALL
Age
0 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Stage 1 Nonpregnant Women: * Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * Negative urine pregnancy test at Visit 1 (prior to vaccination). * Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 1 Booster Vaccination: * Participant must have received investigational product at Visit 1. * Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1. * Negative urine pregnancy test at Visit 6 (prior to vaccination). * Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 2 and 3 Maternal Participants: * Healthy females \>=18 and \<=40 years of age who are \>=27 0/7 (Stage 2) or \>=24 0/7 (Stage 3) to \<=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit. * Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening. Inclusion Criteria Stage 2 and 3 Infant Participants: Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.
Exclusion criteria
Stage 1 Nonpregnant Women: * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine. * History of microbiologically proven invasive disease caused by GBS (S agalactiae). * Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 | From Birth to 12 Months | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection. |
| Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | At Birth | The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory. |
| Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 | At 5 minutes of Birth | Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure. |
| Number of Participants With Vital Status: Infant Participants Stage 3 | At Birth | Participants according to vital status as: live or neonatal death were reported in this outcome measure. |
| Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | From Birth to 6 Weeks | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. |
| Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3 | From Birth to 6 Weeks | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. |
| Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | From Birth to 12 Months | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. 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. |
| Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3 | From Birth to 12 Months | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. 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. |
| Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | From Birth to 12 Months | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. |
| Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3 | From Birth to 12 Months | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. |
| Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | From Birth to 12 Months | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection. |
| Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) to Day 7 after Primary Dose | 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 \[\>\] 2.5 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. |
| Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Day 1 (day of vaccination) to Day 7 after booster dose | 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 \[\>\] 2.5 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. |
| Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) to Day 7 after primary dose | 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, 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. |
| Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) to Day 7 after booster dose | 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, 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. |
| Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) through 1 Month post primary dose | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. |
| Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) through 1 Month post booster dose | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. |
| Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) through 6 Months post primary dose | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) through 6 Months post primary dose | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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. |
| Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. |
| Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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. |
| Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | 2 weeks after vaccination in Stage 2 | Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure. |
| Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Day 1 (day of vaccination) to Day 7 after Vaccination | 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 cm). Grading: Grade 1/mild (\> 2.5 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 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. |
| Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Day 1 (day of vaccination) to Day 7 after Vaccination | 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 cm). Grading: Grade 1/mild (\> 2.5 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 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. |
| Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Day 1 (day of vaccination) to Day 7 after Vaccination | Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 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 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, 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. |
| Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Day 1 (day of vaccination) to Day 7 after Vaccination | Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 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 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, 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. |
| Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | Day 1 (day of vaccination) through 1 Month post vaccination | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. |
| Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3 | Day 1 (day of vaccination) through 1 Month post vaccination | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. |
| Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Day 1 (day of vaccination) through 12 Month post delivery | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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. |
| Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Day 1 (day of vaccination) through 12 Month post delivery | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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. |
| Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Day 1 (day of vaccination) through 12 Month post delivery | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. |
| Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Day 1 (day of vaccination) through 12 Month post delivery | An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. |
| Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Day 1 (day of vaccination) through 12 Month post delivery | Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure. |
| Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Day 1 (day of vaccination) through 12 Month post delivery | Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure. |
| Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | At delivery | Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure. |
| Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | At delivery | Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure. |
| Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | At Birth | Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks. |
| Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | At 1 minute of Birth | APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure. |
| Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | At 5 minutes of Birth | APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure. |
| Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | At Birth | The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory. |
| Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | At Birth | Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure. |
| Number of Participants With Vital Status: Infant Participants Stage 2 | At Birth | Participants according to vital status as: live or neonatal death were reported in this outcome measure. |
| Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | At 1 minute of Birth | Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks. |
| Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3 | At 1 minute of Birth | APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure. |
| APGAR Score at 5 Minutes: Infant Participants Stage 3 | At 5 minutes of Birth | APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | At 1 Month After Vaccination and at Delivery | OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample. |
| GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | At 1 Month After Vaccination and at Delivery | OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample. |
| GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | At Birth | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | At Birth | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | At Birth | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | At Birth | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
| Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | At 1 Month After primary Dose | Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V. |
Countries
South Africa, United Kingdom, United States
Participant flow
Recruitment details
Healthy non-pregnant participants, pregnant maternal participants between 18 to 40 years of age and infants who were born to these maternal participants were enrolled in this study. This study conducted in three stages and participants were enrolled to Stage 1, 2 and 3 separately.
Pre-assignment details
A total of 66 nonpregnant women and 576 maternal participants and their 566 infants were enrolled in this study. Infants were not randomized and vaccinated in this study but summarized according to the vaccine group their mothers were randomized to. Vaccination was administered preferably to the nondominant arm of the participants.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) Nonpregnant participants were randomized to receive a single dose of 20 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly on Day 1. | 22 |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 22 |
| Stage 1: Placebo (Nonpregnant) Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1. | 22 |
| Stage 2: GBS6 5 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 5 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 10 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1. | 120 |
| Stage 2: GBS6 5 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 5 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 39 |
| Stage 2: GBS6 10 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 10 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 20 mcg With AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: GBS6 20 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 40 |
| Stage 2: Placebo (Infant) Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1. | 118 |
| Stage 3: GBS6 20 mcg Without AlPO4 (Maternal) Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AIPO4, intramuscularly on Day 1. | 108 |
| Stage 3: Placebo (Maternal) Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1. | 108 |
| Stage 3: GBS6 20 mcg Without AlPO4 (Infant) Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1. | 104 |
| Stage 3: Placebo (Infant) Infant participants were randomized to receive placebo (saline control) intramuscularly on Day 1. | 105 |
| Total | 1,208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Withdrawal by participant | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Stage 2 | Lost to Follow-up | 0 | 0 | 0 | 5 | 1 | 0 | 3 | 3 | 1 | 6 | 5 | 1 | 1 | 3 | 3 | 1 | 6 | 0 | 0 | 0 | 0 |
| Stage 2 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
| Stage 2 | Withdrawal by parent/guardian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 3 | 1 | 1 | 0 | 3 | 0 | 0 | 0 | 0 |
| Stage 2 | Withdrawal by Subject | 0 | 0 | 0 | 3 | 3 | 3 | 0 | 1 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 3 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Stage 3 | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 |
| Stage 3 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 5 | 7 | 4 |
| Stage 3 | No longer meets eligibility criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Stage 3 | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 2 |
| Stage 3 | Withdrawal by parent/guardian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 9 |
| Stage 3 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 11 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Stage 3: Placebo (Infant) | Stage 3: GBS6 20 mcg Without AlPO4 (Infant) | Stage 3: Placebo (Maternal) | Stage 3: GBS6 20 mcg Without AlPO4 (Maternal) | Stage 2: Placebo (Infant) | Stage 2: GBS6 20 mcg Without AlPO4 (Infant) | Stage 2: GBS6 20 mcg With AlPO4 (Infant) | Stage 2: GBS6 10 mcg Without AlPO4 (Infant) | Stage 2: GBS6 10 mcg With AlPO4 (Infant) | Stage 2: GBS6 5 mcg Without AlPO4 (Infant) | Stage 2: GBS6 5 mcg With AlPO4 (Infant) | Stage 2: Placebo (Maternal) | Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Stage 2: GBS6 10 mcg With AlPO4 (Maternal) | Stage 2: GBS6 5 mcg Without AlPO4 (Maternal) | Stage 2: GBS6 5 mcg With AlPO4 (Maternal) | Stage 1: Placebo (Nonpregnant) | Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-40 Years | 642 Participants | 0 Participants | 0 Participants | 108 Participants | 108 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 120 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 22 Participants | 22 Participants | 22 Participants |
| Age, Customized Full term newborn infants (Gestational age >= 37 weeks) | 539 Participants | 98 Participants | 95 Participants | 0 Participants | 0 Participants | 116 Participants | 39 Participants | 39 Participants | 40 Participants | 39 Participants | 36 Participants | 37 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (Gestational age <37 weeks) | 25 Participants | 6 Participants | 8 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 28 Participants | 6 Participants | 8 Participants | 6 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic/non-Latino | 1180 Participants | 99 Participants | 96 Participants | 102 Participants | 100 Participants | 118 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 39 Participants | 40 Participants | 120 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 22 Participants | 22 Participants | 22 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1101 Participants | 78 Participants | 78 Participants | 80 Participants | 82 Participants | 118 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 39 Participants | 40 Participants | 120 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 22 Participants | 22 Participants | 22 Participants |
| Race/Ethnicity, Customized Race Multiracial | 6 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not reported | 5 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 92 Participants | 22 Participants | 23 Participants | 24 Participants | 23 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 934 Participants | 54 Participants | 60 Participants | 108 Participants | 108 Participants | 55 Participants | 21 Participants | 26 Participants | 20 Participants | 19 Participants | 20 Participants | 17 Participants | 120 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 40 Participants | 22 Participants | 22 Participants | 22 Participants |
| Sex: Female, Male Male | 274 Participants | 51 Participants | 44 Participants | 0 Participants | 0 Participants | 63 Participants | 19 Participants | 14 Participants | 20 Participants | 21 Participants | 19 Participants | 23 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 11 | 0 / 7 | 0 / 8 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 1 / 120 | 0 / 40 | 1 / 39 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 2 / 118 | 0 / 108 | 0 / 108 | 3 / 104 | 2 / 105 |
| other Total, other adverse events | 17 / 22 | 17 / 22 | 18 / 22 | 9 / 11 | 7 / 7 | 8 / 8 | 30 / 40 | 36 / 40 | 31 / 40 | 27 / 40 | 34 / 40 | 36 / 40 | 98 / 120 | 27 / 40 | 19 / 39 | 22 / 40 | 26 / 40 | 20 / 40 | 21 / 40 | 66 / 118 | 91 / 108 | 90 / 108 | 78 / 104 | 81 / 105 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 11 | 0 / 7 | 0 / 8 | 7 / 40 | 18 / 40 | 9 / 40 | 11 / 40 | 8 / 40 | 14 / 40 | 30 / 120 | 17 / 40 | 19 / 39 | 15 / 40 | 12 / 40 | 19 / 40 | 14 / 40 | 60 / 118 | 21 / 108 | 23 / 108 | 45 / 104 | 46 / 105 |
Outcome results
Primary
APGAR Score at 5 Minutes: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.
Time frame: At 5 minutes of Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | APGAR Score at 5 Minutes: Infant Participants Stage 3 | 10.0 Unit on a scale |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | APGAR Score at 5 Minutes: Infant Participants Stage 3 | 10.0 Unit on a scale |
Primary
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.
Time frame: At 1 minute of Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | 9.0 Unit on a scale |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | 9.0 Unit on a scale |
| Stage 1: Placebo (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | 9.0 Unit on a scale |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | 9.0 Unit on a scale |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | 9.0 Unit on a scale |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | 9.0 Unit on a scale |
| Stage 2: Placebo (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2 | 9.0 Unit on a scale |
Primary
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.
Time frame: At 1 minute of Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3 | 9.0 Unit on a scale |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3 | 9.0 Unit on a scale |
Primary
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.
Time frame: At 5 minutes of Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | 10.0 Unit on a scale |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | 10.0 Unit on a scale |
| Stage 1: Placebo (Nonpregnant) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | 10.0 Unit on a scale |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | 10.0 Unit on a scale |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | 10.0 Unit on a scale |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | 10.0 Unit on a scale |
| Stage 2: Placebo (Maternal) | Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2 | 10.0 Unit on a scale |
Primary
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Time frame: At Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | <37 weeks 0 days | 1 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=42 weeks | 1 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 6 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | Not reported | 32 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | <37 weeks 0 days | 2 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=42 weeks | 1 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | Not reported | 33 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 3 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=42 weeks | 1 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | <37 weeks 0 days | 1 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 7 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | Not reported | 31 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 4 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=42 weeks | 1 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | <37 weeks 0 days | 1 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | Not reported | 34 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | <37 weeks 0 days | 2 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=42 weeks | 4 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 3 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | Not reported | 31 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | <37 weeks 0 days | 2 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=42 weeks | 0 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 4 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | Not reported | 34 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=42 weeks | 2 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | <37 weeks 0 days | 4 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | Not reported | 94 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 18 Participants |
Primary
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Time frame: At Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | <37 weeks 0 days | 4 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | >=37 weeks to <42 weeks | 30 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | >=42 weeks | 5 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | Not reported | 65 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | Not reported | 60 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | <37 weeks 0 days | 4 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | >=42 weeks | 4 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3 | >=37 weeks to <42 weeks | 37 Participants |
Primary
Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Time frame: From Birth to 6 Weeks
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | 26 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | 21 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | 25 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | 21 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | 19 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | 18 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2 | 68 Participants |
Primary
Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Time frame: From Birth to 6 Weeks
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3 | 65 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3 | 64 Participants |
Primary
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2
Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.
Time frame: 2 weeks after vaccination in Stage 2
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here , number of participants analyzed signifies number of participants in the sentinel cohort (subset of Stage 2 maternal participants) evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Aspartate aminotransferase Grade 2 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Basophils (Absolute) Grade 2 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 3 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | White blood cells decreased Grade 1 | 15.4 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Hemoglobin Grade 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Blood urea nitrogen Grade 1 | 1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Lymphocytes Low (Absolute) Grade 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Platelets High Grade 2 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alkaline phosphate Grade 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Neutrophils (Absolute) Grade 1 | 7.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Lymphocytes Low (Absolute) Grade 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Aspartate aminotransferase Grade 2 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Basophils (Absolute) Grade 2 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Hemoglobin Grade 1 | 7.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Blood urea nitrogen Grade 1 | 7.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Neutrophils (Absolute) Grade 1 | 35.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 3 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | White blood cells decreased Grade 1 | 21.4 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Platelets High Grade 2 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alkaline phosphate Grade 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 1 | 7.1 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Blood urea nitrogen Grade 1 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Lymphocytes Low (Absolute) Grade 1 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Platelets High Grade 2 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 3 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | White blood cells decreased Grade 1 | 7.1 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Hemoglobin Grade 1 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 1 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Neutrophils (Absolute) Grade 1 | 7.1 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Aspartate aminotransferase Grade 2 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Basophils (Absolute) Grade 2 | 14.3 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alkaline phosphate Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Lymphocytes Low (Absolute) Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Hemoglobin Grade 1 | 7.1 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Platelets High Grade 2 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | White blood cells decreased Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Neutrophils (Absolute) Grade 1 | 21.4 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Basophils (Absolute) Grade 2 | 21.4 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Blood urea nitrogen Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Aspartate aminotransferase Grade 2 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 3 | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alkaline phosphate Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Basophils (Absolute) Grade 2 | 7.1 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Hemoglobin Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Blood urea nitrogen Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Neutrophils (Absolute) Grade 1 | 7.1 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Aspartate aminotransferase Grade 2 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | White blood cells decreased Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alkaline phosphate Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Platelets High Grade 2 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 3 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Lymphocytes Low (Absolute) Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Aspartate aminotransferase Grade 2 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | White blood cells decreased Grade 1 | 8.3 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Hemoglobin Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Basophils (Absolute) Grade 2 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Lymphocytes Low (Absolute) Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Platelets High Grade 2 | 8.3 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alkaline phosphate Grade 1 | 8.3 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 3 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Blood urea nitrogen Grade 1 | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Neutrophils (Absolute) Grade 1 | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 3 | 2.4 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | White blood cells decreased Grade 1 | 7.1 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Basophils (Absolute) Grade 2 | 2.4 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alkaline phosphate Grade 1 | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Hemoglobin Grade 1 | 2.4 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Blood urea nitrogen Grade 1 | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Neutrophils (Absolute) Grade 1 | 9.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Alanine aminotransferase Grade 1 | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Platelets High Grade 2 | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Aspartate aminotransferase Grade 2 | 2.4 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2 | Lymphocytes Low (Absolute) Grade 1 | 2.4 Percentage of Participants |
Primary
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3
Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks.
Time frame: At 1 minute of Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=28 weeks to <34 weeks | 1 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=37 weeks to <42 weeks | 94 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=42 weeks | 1 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=34 weeks to <37 weeks | 7 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | Unknown | 1 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=24 weeks to <28 weeks | 0 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | Unknown | 1 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=24 weeks to <28 weeks | 0 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=28 weeks to <34 weeks | 2 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=34 weeks to <37 weeks | 4 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=37 weeks to <42 weeks | 94 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3 | >=42 weeks | 4 Participants |
Primary
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Time frame: From Birth to 12 Months
Population: Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 22 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 14 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 19 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 21 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 18 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 18 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 58 Participants |
Primary
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Time frame: From Birth to 12 Months
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3 | 65 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3 | 66 Participants |
Primary
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Time frame: At Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Congenital malformation/anomaly | 7 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Other neonatal problem | 3 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Normal | 34 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Congenital malformation/anomaly | 8 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Normal | 30 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Other neonatal problem | 4 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Congenital malformation/anomaly | 2 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Normal | 38 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Other neonatal problem | 2 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Congenital malformation/anomaly | 2 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Other neonatal problem | 2 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Normal | 38 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Normal | 34 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Other neonatal problem | 2 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Congenital malformation/anomaly | 5 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Normal | 35 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Congenital malformation/anomaly | 6 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Other neonatal problem | 4 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Congenital malformation/anomaly | 26 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Normal | 89 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2 | Other neonatal problem | 5 Participants |
Primary
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Time frame: At 5 minutes of Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 | Normal | 82 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 | Congenital malformation/anomaly | 15 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 | Other neonatal problem | 12 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 | Normal | 79 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 | Congenital malformation/anomaly | 16 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3 | Other neonatal problem | 15 Participants |
Primary
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. 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: From Birth to 12 Months
Population: Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 17 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 19 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 15 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 12 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 19 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 14 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2 | 60 Participants |
Primary
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. 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: From Birth to 12 Months
Population: Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3 | 45 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3 | 46 Participants |
Primary
Number of Participants With Vital Status: Infant Participants Stage 2
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Time frame: At Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 2 | Live | 40 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 2 | Neonatal death | 0 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 2 | Live | 38 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 2 | Neonatal death | 1 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 2 | Live | 40 Participants |
| Stage 1: Placebo (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 2 | Neonatal death | 0 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Live | 40 Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Neonatal death | 0 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Live | 40 Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Neonatal death | 0 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Live | 40 Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Neonatal death | 0 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Neonatal death | 1 Participants |
| Stage 2: Placebo (Maternal) | Number of Participants With Vital Status: Infant Participants Stage 2 | Live | 117 Participants |
Primary
Number of Participants With Vital Status: Infant Participants Stage 3
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Time frame: At Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 3 | Live | 103 Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 3 | Neonatal death | 1 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 3 | Neonatal death | 1 Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Number of Participants With Vital Status: Infant Participants Stage 3 | Live | 104 Participants |
Primary
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Time frame: Day 1 (day of vaccination) through 1 Month post primary dose
Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1 | 54.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1 | 45.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1 | 36.4 Percentage of Participants |
Primary
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Time frame: Day 1 (day of vaccination) through 1 Month post vaccination
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | 27.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | 40.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | 22.5 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | 22.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | 30.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | 30.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2 | 27.5 Percentage of Participants |
Primary
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Time frame: Day 1 (day of vaccination) through 1 Month post vaccination
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3 | 36.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3 | 32.4 Percentage of Participants |
Primary
Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Time frame: Day 1 (day of vaccination) through 1 Month post booster dose
Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1 | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1 | 12.5 Percentage of Participants |
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1
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 \[\>\] 2.5 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 after booster dose
Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Mild) | 45.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Moderate) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Moderate) | 27.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Mild) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Any) | 72.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Mild) | 28.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Any) | 28.6 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Moderate) | 12.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Any) | 50.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Mild) | 37.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Any) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Any) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1 | Induration/swelling (Severe) | 0 Percentage of Participants |
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
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 \[\>\] 2.5 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 after Primary Dose
Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Any) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Mild) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Mild) | 22.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Moderate) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Mild) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Any) | 27.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Moderate) | 13.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Any) | 27.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Mild) | 13.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Any) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Moderate) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Mild) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Moderate) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Any) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Moderate) | 4.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Mild) | 9.1 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Mild) | 4.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Pain at injection site (Any) | 13.6 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Erythema/redness (Any) | 4.5 Percentage of Participants |
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2
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 cm). Grading: Grade 1/mild (\> 2.5 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 (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 after Vaccination
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Mild) | 32.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Moderate) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Any) | 37.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Any) | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Moderate) | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Any) | 15.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Mild) | 12.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Mild) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Any) | 40.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Mild) | 35.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Moderate) | 5.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Any) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Severe) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Any) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Severe) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Any) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Mild) | 15.4 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Mild) | 2.6 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Any) | 2.6 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Any) | 15.4 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Any) | 5.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Mild) | 42.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Mild) | 5.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Any) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Mild) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Any) | 47.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Moderate) | 5.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Mild) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Moderate) | 15.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Any) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Mild) | 20.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Mild) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Any) | 35.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Any) | 2.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Moderate) | 0.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Mild) | 0.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Mild) | 12.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Any) | 1.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Moderate) | 3.3 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Pain at injection site (Any) | 15.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Any) | 0.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2 | Erythema/redness (Moderate) | 0.8 Percentage of Participants |
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3
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 cm). Grading: Grade 1/mild (\> 2.5 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 (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 after Vaccination
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Any) | 30.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Mild) | 25.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Moderate) | 4.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Any) | 18.4 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Mild) | 13.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Moderate) | 4.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Erythema/redness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Induration/swelling (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3 | Pain at injection site (Grade 4) | 0 Percentage of Participants |
Primary
Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Time frame: Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | 14.3 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | 25.0 Percentage of Participants |
Primary
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Time frame: Day 1 (day of vaccination) through 6 Months post primary dose
Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | 45.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | 40.9 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | 40.9 Percentage of Participants |
Primary
Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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 approximately 7 to 12 months post booster dose
Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
Primary
Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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 primary dose
Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1 | 0 Percentage of Participants |
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1
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, 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 after booster dose
Population: Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Moderate) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Moderate) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Mild) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Any) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Any) | 27.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Any) | 27.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Moderate) | 27.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Moderate) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Moderate) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Any) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Mild) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Any) | 14.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Mild) | 14.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Any) | 14.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Mild) | 14.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Any) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Any) | 14.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Mild) | 14.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Any) | 12.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Any) | 37.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Mild) | 25.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Moderate) | 12.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Mild) | 25.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Moderate) | 12.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Any) | 25.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Moderate) | 37.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Any) | 62.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Headache (Mild) | 25.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Any) | 37.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Moderate) | 12.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Mild) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Any) | 12.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Moderate) | 37.5 Percentage of Participants |
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
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, 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 after primary dose
Population: Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Mild) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Mild) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Any) | 31.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Mild) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Moderate) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Mild) | 31.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Any) | 36.4 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Any) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Any) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (>=38.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Mild) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Moderate) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Mild) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Moderate) | 13.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (>=38.0 deg C) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Mild) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Moderate) | 22.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Any) | 31.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Any) | 22.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (38.5 to 38.9 deg C) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Mild) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Moderate) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Any) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Any) | 40.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Mild) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Mild) | 22.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Moderate) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Mild) | 13.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Moderate) | 9.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Any) | 18.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Mild) | 13.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Moderate) | 4.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Mild) | 31.8 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Moderate) | 18.2 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Any) | 4.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Moderate) | 9.1 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Mild) | 9.1 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Any) | 27.3 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Moderate) | 13.6 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Mild) | 4.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Mild) | 18.2 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Any) | 22.7 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Moderate) | 4.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Joint Pain (Moderate) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Any) | 50.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Mild) | 31.8 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Moderate) | 4.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Mild) | 13.6 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fever (>=38.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Diarrhea (Any) | 18.2 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Any) | 40.9 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2
Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 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 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, 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 after Vaccination
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Any) | 12.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Any) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Mild) | 7.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.0 to 38.4 deg C) | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Mild) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>=38.0 deg C) | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Moderate) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Moderate) | 10.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Mild) | 27.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Mild) | 22.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Any) | 10.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Any) | 15.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Any) | 30.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Moderate) | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Mild) | 10.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Moderate) | 7.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Moderate) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Any) | 37.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Mild) | 7.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Moderate) | 10.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>=38.0 deg C) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Mild) | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Moderate) | 12.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Any) | 17.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Mild) | 37.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Moderate) | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Any) | 7.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Any) | 25.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Mild) | 12.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Moderate) | 22.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Moderate) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.5 to 38.9 deg C) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Mild) | 12.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Mild) | 22.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Mild) | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Any) | 10.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Any) | 47.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Moderate) | 7.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Any) | 45.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Any) | 30.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Mild) | 15.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Moderate) | 15.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Mild) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Any) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Any) | 20.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>=38.0 deg C) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Mild) | 17.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Moderate) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Moderate) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Mild) | 15.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Any) | 17.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Any) | 10.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Mild) | 7.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Moderate) | 12.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Moderate) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.0 to 38.4 deg C) | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Mild) | 25.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Any) | 37.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Any) | 12.8 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>=38.0 deg C) | 7.7 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.0 to 38.4 deg C) | 5.1 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (39.0 to 40.0 deg C) | 2.6 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Any) | 15.4 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Mild) | 10.3 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Moderate) | 5.1 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Any) | 23.1 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Mild) | 7.7 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Moderate) | 12.8 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Severe) | 2.6 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Any) | 33.3 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Mild) | 17.9 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Moderate) | 15.4 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Any) | 38.5 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Mild) | 17.9 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Moderate) | 17.9 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Severe) | 2.6 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Any) | 15.4 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Mild) | 10.3 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Moderate) | 5.1 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Mild) | 7.7 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Moderate) | 5.1 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Severe) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.0 to 38.4 deg C) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (39.0 to 40.0 deg C) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Any) | 17.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Moderate) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Moderate) | 7.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Any) | 15.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Mild) | 35.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Mild) | 12.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Mild) | 25.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Any) | 7.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Moderate) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Mild) | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Any) | 47.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Moderate) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Mild) | 12.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Mild) | 7.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Severe) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Any) | 32.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>=38.0 deg C) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Any) | 15.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Moderate) | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Severe) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Any) | 20.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Any) | 42.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.5 to 38.9 deg C) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Any) | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Mild) | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.0 to 38.4 deg C) | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Mild) | 22.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Moderate) | 17.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Any) | 40.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Moderate) | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Any) | 25.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>=38.0 deg C) | 5.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Moderate) | 5.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Mild) | 12.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Mild) | 30.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Mild) | 17.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Moderate) | 12.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Mild) | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Any) | 22.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Moderate) | 12.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Severe) | 0.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (>=38.0 deg C) | 5.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Any) | 40.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Moderate) | 0.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Mild) | 23.3 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Mild) | 15.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Moderate) | 14.2 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Any) | 16.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Severe) | 2.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Any) | 15.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Moderate) | 7.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Severe) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Mild) | 10.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Mild) | 19.2 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Moderate) | 5.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Nausea/vomiting (Any) | 26.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Moderate) | 5.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Any) | 16.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.5 to 38.9 deg C) | 1.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Joint pain (Mild) | 11.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Fever (38.0 to 38.4 deg C) | 3.3 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Mild) | 25.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Moderate) | 7.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Any) | 33.3 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Headache (Severe) | 0.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2 | Diarrhea (Grade 4) | 0 Percentage of Participants |
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3
Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 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 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, 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 after Vaccination
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (38.0 to 38.4 deg C) | 2.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Mild) | 19.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Mild) | 18.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Any) | 15.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Moderate) | 2.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (38.5 to 38.9 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Any) | 42.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Mild) | 24.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Moderate) | 17.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Moderate) | 17.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Any) | 12.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Any) | 18.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (>=38.0 deg C) | 2.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Mild) | 13.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Mild) | 12.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Moderate) | 5.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Moderate) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Mild) | 9.4 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Moderate) | 5.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Any) | 21.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Any) | 36.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (>=38.0 deg C) | 4.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (38.0 to 38.4 deg C) | 2.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (38.5 to 38.9 deg C) | 1.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (39.0 to 40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fever (>40.0 deg C) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Any) | 29.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Mild) | 22.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Moderate) | 6.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Nausea/vomiting (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Any) | 11.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Moderate) | 2.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Any) | 37.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Mild) | 30.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Moderate) | 7.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Headache (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Any) | 42.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Mild) | 24.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Moderate) | 15.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Severe) | 2.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Fatigue/tiredness (Grade 4) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Any) | 14.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Mild) | 5.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Moderate) | 8.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Muscle pain (Severe) | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Diarrhea (Mild) | 8.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Any) | 13.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Mild) | 8.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Moderate) | 3.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3 | Joint pain (Severe) | 1.0 Percentage of Participants |
Primary
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Time frame: From Birth to 12 Months
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Suspected or confirmed GBS infection | 0 Participants of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Developmental delay | 0 Participants of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Major congenital anomalies | 0 Participants of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Suspected or confirmed GBS infection | 0 Participants of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Developmental delay | 2.6 Participants of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Major congenital anomalies | 2.6 Participants of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Suspected or confirmed GBS infection | 0 Participants of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Developmental delay | 0 Participants of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Major congenital anomalies | 2.5 Participants of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Suspected or confirmed GBS infection | 0 Participants of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Developmental delay | 0 Participants of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Major congenital anomalies | 0 Participants of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Major congenital anomalies | 0 Participants of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Suspected or confirmed GBS infection | 0 Participants of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Developmental delay | 2.5 Participants of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Developmental delay | 0 Participants of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Suspected or confirmed GBS infection | 0 Participants of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Major congenital anomalies | 0 Participants of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Major congenital anomalies | 1.7 Participants of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Suspected or confirmed GBS infection | 0 Participants of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2 | Developmental delay | 0.8 Participants of Participants |
Primary
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Time frame: From Birth to 12 Months
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 | Major congenital anomalies | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 | Developmental delay | 1.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 | Suspected or confirmed GBS infection | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 | Suspected or confirmed GBS infection | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 | Major congenital anomalies | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3 | Developmental delay | 0 Percentage of Participants |
Primary
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Time frame: At delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Full term live delivery | 92.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: semi-elective | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Stillbirth | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: elective | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: emergency | 10.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Premature live delivery | 7.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery outcome-Unknown | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Vaginal delivery | 85.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery mode-Unknown | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: emergency | 27.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery mode-Unknown | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Full term live delivery | 90.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: elective | 12.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Stillbirth | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery outcome-Unknown | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Premature live delivery | 7.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: semi-elective | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Vaginal delivery | 60.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Vaginal delivery | 82.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery outcome-Unknown | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: emergency | 10.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Premature live delivery | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Full term live delivery | 97.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: semi-elective | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Stillbirth | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery mode-Unknown | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: elective | 7.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Full term live delivery | 100.0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Premature live delivery | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Stillbirth | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery outcome-Unknown | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Vaginal delivery | 67.5 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: elective | 5.0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: semi-elective | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: emergency | 27.5 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery mode-Unknown | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Stillbirth | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: emergency | 12.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Premature live delivery | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery outcome-Unknown | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: semi-elective | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Vaginal delivery | 82.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery mode-Unknown | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: elective | 5.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Full term live delivery | 97.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: semi-elective | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Vaginal delivery | 70.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Stillbirth | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: elective | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Premature live delivery | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery mode-Unknown | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Full term live delivery | 97.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: emergency | 20.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery outcome-Unknown | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Premature live delivery | 2.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Stillbirth | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: emergency | 12.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery mode-Unknown | 1.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Vaginal delivery | 76.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: semi-elective | 0.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Full term live delivery | 95.8 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Delivery outcome-Unknown | 1.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2 | Cesarean section: elective | 8.3 Percentage of Participants |
Primary
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Time frame: At delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Premature live delivery | 7.4 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Full term live delivery | 88.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Cesarean section: elective | 12.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Stillbirth | 0.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Cesarean section: semi-elective | 1.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Vaginal delivery | 72.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Cesarean section: emergency | 10.2 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Delivery outcome-Unknown | 3.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Delivery mode-Unknown | 3.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Delivery mode-Unknown | 2.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Induced/elective abortion | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Full term live delivery | 91.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Premature live delivery | 5.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Stillbirth | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Delivery outcome-Unknown | 2.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Vaginal delivery | 75.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Cesarean section: elective | 9.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Cesarean section: semi-elective | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3 | Cesarean section: emergency | 12.0 Percentage of Participants |
Primary
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2
Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks.
Time frame: At Birth
Population: Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=34 weeks to <37 weeks | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=24 weeks to <28 weeks | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=28 weeks to <34 weeks | 2.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 87.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=42 weeks | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=34 weeks to <37 weeks | 5.1 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=24 weeks to <28 weeks | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=42 weeks | 7.7 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=28 weeks to <34 weeks | 2.6 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 84.6 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=34 weeks to <37 weeks | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 97.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=24 weeks to <28 weeks | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=42 weeks | 0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=28 weeks to <34 weeks | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=42 weeks | 7.5 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=28 weeks to <34 weeks | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=24 weeks to <28 weeks | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=34 weeks to <37 weeks | 0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 92.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 95.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=28 weeks to <34 weeks | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=42 weeks | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=34 weeks to <37 weeks | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=24 weeks to <28 weeks | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=24 weeks to <28 weeks | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=34 weeks to <37 weeks | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=42 weeks | 2.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 95.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=28 weeks to <34 weeks | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=37 weeks to <42 weeks | 94.9 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=42 weeks | 3.4 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=28 weeks to <34 weeks | 0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=34 weeks to <37 weeks | 1.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2 | >=24 weeks to <28 weeks | 0 Percentage of Participants |
Primary
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 30.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 45.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 30.0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 27.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 25.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 32.5 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 42.5 Percentage of Participants |
Primary
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | 51.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | 42.6 Percentage of Participants |
Primary
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Prepartum Period | 9.3 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Intrapartum Period | 13.9 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Postpartum Period | 2.8 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Prepartum Period | 13.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Intrapartum Period | 13.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | Postpartum Period | 1.9 Percentage of Participants |
Primary
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Time frame: Day 1 (day of vaccination) through 12 Month post delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Postpartum Period | 0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Intrapartum Period | 10.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Prepartum Period | 5.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Intrapartum Period | 30.0 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Prepartum Period | 12.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Postpartum Period | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Postpartum Period | 2.5 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Prepartum Period | 5.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Intrapartum Period | 10.0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Intrapartum Period | 15.0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Prepartum Period | 10.0 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Postpartum Period | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Intrapartum Period | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Prepartum Period | 5.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Postpartum Period | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Prepartum Period | 10.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Postpartum Period | 0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Intrapartum Period | 20.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Postpartum Period | 1.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Intrapartum Period | 11.7 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | Prepartum Period | 11.7 Percentage of Participants |
Primary
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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 12 Month post delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 17.5 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 45.0 Percentage of Participants |
| Stage 1: Placebo (Nonpregnant) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 22.5 Percentage of Participants |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 27.5 Percentage of Participants |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 20.0 Percentage of Participants |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 35.0 Percentage of Participants |
| Stage 2: Placebo (Maternal) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2 | 25.0 Percentage of Participants |
Primary
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. 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 12 Month post delivery
Population: Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | 19.4 Percentage of Participants |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3 | 21.3 Percentage of Participants |
Secondary
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
Time frame: At 1 Month After Vaccination and at Delivery
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib: at delivery | 7011.6 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V: at 1 month | 9258.1 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia: at 1 month | 11462.9 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V: at delivery | 5501.3 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II: at 1 month | 35652.7 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II: at delivery | 22650.9 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib: at 1 month | 13306.1 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III: at 1 month | 9064.7 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia: at delivery | 6228.2 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III: at delivery | 5822.1 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV: at delivery | 8242.0 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV: at 1 month | 11800.6 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV: at delivery | 1164.0 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia: at delivery | 211.4 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib: at 1 month | 480.8 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib: at delivery | 481.6 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II: at 1 month | 1911.7 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV: at 1 month | 1152.1 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia: at 1 month | 196.1 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V: at 1 month | 846.0 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V: at delivery | 837.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II: at delivery | 1998.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III: at 1 month | 511.9 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III: at delivery | 561.7 Titer |
Secondary
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: At Birth
Population: Evaluable immunogenicity population.Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | IV | 276.7 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ib | 410.3 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | V | 91.2 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | II | 440.3 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | III | 452.2 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ia | 991.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ib | 357.2 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | III | 249.1 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | V | 162.4 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ia | 2116.3 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | II | 399.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | IV | 379.3 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ib | 986.5 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | II | 689.0 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | IV | 258.8 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | III | 698.4 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ia | 1927.4 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | V | 143.7 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ib | 1160.5 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | IV | 439.2 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | V | 521.2 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | III | 479.0 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | II | 606.8 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ia | 3053.1 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | II | 1049.9 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ia | 1459.1 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ib | 451.1 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | III | 634.2 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | IV | 438.8 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | V | 219.1 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | V | 1189.4 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | III | 766.9 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | IV | 1071.2 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ib | 1879.2 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ia | 7916.5 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | II | 3262.2 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | III | 79.2 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | IV | 157.2 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ib | 137.1 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | Ia | 91.3 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | II | 212.8 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2 | V | 98.3 Titer |
Secondary
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: At Birth
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | Ib | 1108.3 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | Ia | 1173.7 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | IV | 854.0 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | II | 3639.4 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | V | 393.8 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | III | 1005.6 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | V | 127.8 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | Ia | 89.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | Ib | 114.8 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | II | 291.0 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | III | 77.1 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3 | IV | 160.2 Titer |
Secondary
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
Time frame: At 1 Month After Vaccination and at Delivery
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 11534.8 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 13012.1 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 6591.5 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At delivery) | 5105.3 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 3048.0 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At delivery) | 14876.0 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At delivery) | 2450.4 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At delivery) | 8074.3 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 9908.6 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 4026.7 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At delivery) | 10500.3 Titer |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At delivery) | 9573.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At delivery) | 6521.0 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 10639.1 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At delivery) | 3959.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 6087.6 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 7765.3 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 5486.1 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At delivery) | 3109.0 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 5568.4 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 3285.5 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At delivery) | 12259.3 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At delivery) | 7160.6 Titer |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At delivery) | 6302.6 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 14408.2 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 9835.4 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At delivery) | 14665.8 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 16560.9 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At delivery) | 18640.8 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 11207.9 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At delivery) | 5229.1 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 8773.7 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At delivery) | 7713.8 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At delivery) | 7560.6 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 7288.6 Titer |
| Stage 1: Placebo (Nonpregnant) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At delivery) | 6309.7 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At delivery) | 9305.9 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 8564.5 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 3884.7 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 5272.9 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 9031.8 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At delivery) | 10741.1 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 7862.5 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At delivery) | 3850.2 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At delivery) | 2145.3 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At delivery) | 10501.6 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At delivery) | 7494.3 Titer |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 9722.0 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At delivery) | 7557.0 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 6576.7 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 4359.2 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 9693.4 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At delivery) | 4642.9 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 8133.8 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At delivery) | 11820.6 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At delivery) | 16005.8 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At delivery) | 13197.3 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 4829.8 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At delivery) | 5669.2 Titer |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 13747.4 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At delivery) | 5209.2 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 8570.4 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At delivery) | 7316.2 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 5607.4 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 22480.0 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At delivery) | 13037.0 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 20896.2 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At delivery) | 19559.7 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At delivery) | 19050.4 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 23271.2 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At delivery) | 5364.8 Titer |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 7463.5 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At delivery) | 429.6 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 547.2 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At delivery) | 794.2 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At delivery) | 1012.0 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 790.8 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 864.9 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At delivery) | 228.0 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 200.2 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 856.3 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 1303.1 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At delivery) | 1146.0 Titer |
| Stage 2: Placebo (Maternal) | GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At delivery) | 649.1 Titer |
Secondary
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: At 1 Month After primary Dose
Population: Evaluable immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | Ia | 64.729 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | Ib | 4.986 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | II | 23.359 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | III | 22.622 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | IV | 5.748 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | V | 0.599 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | V | 0.420 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | II | 37.920 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | III | 19.065 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | IV | 2.564 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | Ia | 25.781 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | Ib | 5.546 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | IV | 0.041 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | Ib | 0.019 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | II | 0.179 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | V | 0.058 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | Ia | 0.152 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1 | III | 0.068 microgram per milliliter |
Secondary
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: At Birth
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ia | 4.322 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ib | 0.155 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | IV | 0.993 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | III | 0.954 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | V | 0.084 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | II | 7.680 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ib | 0.182 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ia | 10.978 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | II | 1.935 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | III | 1.009 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | IV | 0.448 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | V | 0.090 Microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | II | 5.190 Microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | IV | 0.759 Microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ia | 6.128 Microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | III | 0.917 Microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ib | 0.481 Microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | V | 0.183 Microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ib | 0.427 Microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ia | 11.089 Microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | V | 1.255 Microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | II | 4.522 Microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | III | 0.906 Microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | IV | 0.550 Microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | V | 0.327 Microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ia | 6.094 Microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | III | 1.085 Microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | II | 12.594 Microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ib | 0.253 Microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | IV | 1.104 Microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | V | 0.502 Microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | II | 16.979 Microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ib | 0.655 Microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | IV | 1.903 Microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | III | 3.417 Microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ia | 22.159 Microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | III | 0.017 Microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ib | 0.007 Microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | II | 0.080 Microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | IV | 0.007 Microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | V | 0.010 Microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2 | Ia | 0.047 Microgram per milliliter |
Secondary
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: At Birth
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | Ib | 0.466 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | III | 3.609 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | Ia | 6.366 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | IV | 2.124 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | II | 16.123 Microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | V | 0.278 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | II | 0.134 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | Ia | 0.048 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | Ib | 0.009 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | V | 0.011 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | III | 0.024 Microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3 | IV | 0.013 Microgram per milliliter |
Secondary
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At Delivery) | 1.690 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 0.115 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 1.294 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At Delivery) | 0.453 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 0.275 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At Delivery) | 0.188 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 1.198 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Week 2) | 0.270 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Week 2) | 1.219 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At Delivery) | 8.676 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At Delivery) | 2.518 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At Delivery) | 11.940 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Week 2) | 0.114 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Week 2) | 1.518 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 7.784 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Week 2) | 8.153 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 8.850 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Week 2) | 8.399 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Week 2) | 0.217 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 0.382 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 4.555 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At Delivery) | 0.293 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Week 2) | 0.306 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At Delivery) | 0.556 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Week 2) | 5.294 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 1.638 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At Delivery) | 13.901 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At Delivery) | 1.657 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Week 2) | 0.831 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 0.783 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 0.222 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Week 2) | 16.089 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Week 2) | 2.165 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 14.987 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At Delivery) | 0.252 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At Delivery) | 3.220 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At Delivery) | 9.676 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Week 2) | 8.232 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Week 2) | 0.315 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Week 2) | 11.073 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At Delivery) | 0.919 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Week 2) | 4.164 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 0.610 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At Delivery) | 1.624 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At Delivery) | 0.625 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 10.449 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 14.356 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At Delivery) | 6.152 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 0.350 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 1.563 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At Delivery) | 14.492 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 7.260 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Week 2) | 0.522 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Week 2) | 1.783 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Week 2) | 0.839 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At Delivery) | 20.078 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At Delivery) | 1.668 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 3.944 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 2.089 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Week 2) | 10.782 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 16.283 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Week 2) | 1.354 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 1.102 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Week 2) | 7.933 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 9.691 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At Delivery) | 7.158 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Week 2) | 2.344 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At Delivery) | 3.199 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Week 2) | 1.912 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At Delivery) | 1.986 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 1.158 microgram per milliliter |
| Stage 2: GBS6 10 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At Delivery) | 1.462 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 12.468 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Week 2) | 0.698 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At Delivery) | 15.543 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Week 2) | 13.813 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At Delivery) | 21.991 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Week 2) | 2.117 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 1.627 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At Delivery) | 2.591 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Week 2) | 2.087 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 1.219 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At Delivery) | 0.853 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At Delivery) | 1.821 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At Delivery) | 0.844 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 17.399 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Week 2) | 0.755 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 0.750 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Week 2) | 16.009 microgram per milliliter |
| Stage 2: GBS6 20 mcg With AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 0.566 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At Delivery) | 0.901 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 27.493 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 2.442 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Week 2) | 1.245 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Week 2) | 22.272 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At Delivery) | 6.609 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At Delivery) | 39.831 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Week 2) | 4.979 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At Delivery) | 25.853 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 47.200 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At Delivery) | 1.388 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Week 2) | 41.201 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 1.284 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Week 2) | 0.534 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 0.729 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Week 2) | 1.700 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At Delivery) | 2.469 microgram per milliliter |
| Stage 2: GBS6 20 mcg Without AlPO4 (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 5.674 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (At Delivery) | 0.012 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (At Delivery) | 0.023 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Week 2) | 0.020 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (At Delivery) | 0.016 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Month 1) | 0.014 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Month 1) | 0.009 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Month 1) | 0.013 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (At Delivery) | 0.012 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ib (Week 2) | 0.009 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (At Delivery) | 0.116 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Month 1) | 0.112 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Month 1) | 0.092 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (Week 2) | 0.095 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | II (At Delivery) | 0.139 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | Ia (Week 2) | 0.099 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | V (Week 2) | 0.014 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | III (Month 1) | 0.022 microgram per milliliter |
| Stage 2: Placebo (Maternal) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2 | IV (Week 2) | 0.009 microgram per milliliter |
Secondary
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia (Month 1) | 9.631 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V (Week 2) | 0.760 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia (At Delivery) | 8.817 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III (Week 2) | 6.422 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib (Week 2) | 0.815 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V (Month 1) | 0.732 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib (Month 1) | 0.832 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II (Month 1) | 32.831 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib (At Delivery) | 0.645 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II (At Delivery) | 22.460 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V (At Delivery) | 0.452 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III (Month 1) | 7.158 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III (At Delivery) | 5.641 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV (At Delivery) | 2.708 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV (Week 2) | 5.719 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia (Week 2) | 9.233 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV (Month 1) | 4.598 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II (Week 2) | 40.234 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV (Month 1) | 0.014 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib (At Delivery) | 0.011 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II (Week 2) | 0.149 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II (At Delivery) | 0.146 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III (Month 1) | 0.034 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV (At Delivery) | 0.012 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V (Week 2) | 0.013 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V (Month 1) | 0.014 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | V (At Delivery) | 0.012 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia (Week 2) | 0.051 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia (Month 1) | 0.054 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ia (At Delivery) | 0.052 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib (Week 2) | 0.009 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | II (Month 1) | 0.140 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III (Week 2) | 0.034 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | III (At Delivery) | 0.031 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | IV (Week 2) | 0.014 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3 | Ib (Month 1) | 0.011 microgram per milliliter |
Secondary
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Time frame: Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose
Population: Evaluable immunogenicity population. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Before) | 0.245 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 6) | 51.631 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 6) | 38.482 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 1) | 36.579 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 1) | 29.416 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Before) | 6.765 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Before) | 4.041 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 1) | 8.208 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 3) | 25.006 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Before) | 0.949 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 1) | 33.784 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Before) | 1.643 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 3) | 16.062 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 3) | 14.744 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 3) | 4.454 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 6) | 9.750 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Before) | 21.088 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 3) | 64.110 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 6) | 3.086 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 1) | 86.661 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 3) | 60.200 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 6) | 21.808 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 6) | 11.053 microgram per milliliter |
| Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 1) | 113.187 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Before) | 3.058 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 3) | 18.206 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 6) | 12.540 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Before) | 0.351 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 6) | 3.325 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Before) | 0.261 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 1) | 92.478 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 1) | 7.177 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Before) | 0.215 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 3) | 3.782 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 6) | 2.594 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 1) | 48.241 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 3) | 62.160 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 6) | 48.827 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 1) | 30.831 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 1) | 11.171 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 6) | 18.936 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 1) | 14.228 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 3) | 5.820 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 3) | 6.134 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Before) | 3.230 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 3) | 27.000 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Before) | 10.338 microgram per milliliter |
| Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 6) | 4.033 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 6) | 4.666 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 1) | 68.222 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 3) | 49.958 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Month 6) | 23.140 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Before) | 0.057 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 1) | 6.176 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 3) | 3.479 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ib (Month 6) | 2.304 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 1) | 48.523 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 3) | 32.569 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Month 6) | 24.262 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 1) | 14.092 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Before) | 0.031 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 1) | 14.942 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 3) | 7.524 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | Ia (Before) | 0.812 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | II (Before) | 0.185 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Before) | 0.084 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 3) | 7.729 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | III (Month 6) | 4.941 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | IV (Month 6) | 4.918 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Before) | 0.080 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 1) | 6.511 microgram per milliliter |
| Stage 1: Placebo (Nonpregnant) | GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1 | V (Month 3) | 5.400 microgram per milliliter |