Bacterial Infection Due to Streptococcus, Group B, Streptococcus Agalactiae
Conditions
Brief summary
The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.
Interventions
BIOLOGICALGBS Trivalent Vaccine
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 .
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 46 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent Vaccine or placebo in the V98\_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past 2. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator 3. Females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of non-childbearing potential
Exclusion criteria
1. Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws 2. Abnormal function of the immune system 3. Received immunoglobulins or any blood products within 180 days prior to informed consent 4. Received an investigational or non-registered medicinal product within 30 days prior to informed consent 5. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study 6. Individuals who received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination 7. Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding 8. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98\_06 study 9. Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to day 1 or use of antipyretics and/or analgesic medications within 24 hours prior to day 1 10. Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | At Day 61 | Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA). |
| Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | At Day 61 | Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | At Day 61 | Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Day 1 to Day 7 | Threshold for Erythema, Swelling and Induration: None (0 mm), Any (\>= 1 mm). |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Day 1 to Day 31 | The number of subjects with any unsolicited AEs from the day of vaccination in study V98\_06E1 to Day 31. An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified. |
| Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | Day 1 to Day 181 | An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Medically attended adverse event is defined as an adverse event that leads to a visit to a healthcare provider and AEs leading to withdrawal are defined as adverse events leading to study or vaccine withdrawal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | At Day 1, Day 31 and Day 61 | The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. |
| Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | At Day 1, Day 31 and Day 61 | The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | At Day 1, Day 31 and Day 61 | The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | At Day 31 | Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 31 post-vaccination, as measured by ELISA. |
| Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | At Day 1, Day 31 and Day 61 | The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | At Day 1, Day 31 and Day 61 | The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects | At Day 1 (V98_06 or V98_06E1) and Day 61 | Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations (95%CI) in All Subjects at Day 1 Pre-vaccination in the V98\_06 study or V98\_06E1 for the Naive Group and at Day 61 Post-vaccination in Study V98\_06E1. Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other Cross Reactive Material(CRM)-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations. |
| Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | At Day 1, Day 31 and Day 61 | The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. |
| Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | At Day 31 | Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | At Day 31 | Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | At Day 1, Day 31 and Day 61. | The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in All Subjects were estimated for at Day 1, Day 31 and Day 61. |
| Geometric Mean Antibody Concentrations of GBS Serotype Ib | At Day 1, Day 31 and Day 61 | The Geometric Mean Antibody Concentrations of GBS Serotype Ib in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
| Geometric Mean Antibody Concentrations of GBS Serotype III | At Day 1, Day 31 and Day 61 | The Geometric Mean Antibody Concentrations of GBS Serotype III in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
Countries
Belgium
Participant flow
Recruitment details
Subjects were recruited from 1 site in Belgium.
Pre-assignment details
All enrolled subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| GBS NoAdj/GBS NoAdj Group Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). | 14 |
| GBS Alum/GBS NoAdj Group Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). | 14 |
| GBS MF59 Half/GBS NoAdj Group Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). | 15 |
| GBS MF59 Full/GBS NoAdj Group Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). | 10 |
| Placebo/GBS NoAdj Group Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). | 6 |
| Naive/GBS NoAdj Group Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181). | 21 |
| Total | 80 |
Baseline characteristics
| Characteristic | GBS NoAdj/GBS NoAdj Group | GBS Alum/GBS NoAdj Group | GBS MF59 Half/GBS NoAdj Group | GBS MF59 Full/GBS NoAdj Group | Placebo/GBS NoAdj Group | Naive/GBS NoAdj Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.4 Years STANDARD_DEVIATION 6.91 | 31.6 Years STANDARD_DEVIATION 6.06 | 28.9 Years STANDARD_DEVIATION 4.68 | 29.7 Years STANDARD_DEVIATION 6.22 | 28.3 Years STANDARD_DEVIATION 5.39 | 29.2 Years STANDARD_DEVIATION 6.96 | 30.1 Years STANDARD_DEVIATION 6.19 |
| Race/Ethnicity, Customized White | 14 Participants | 14 Participants | 15 Participants | 10 Participants | 6 Participants | 21 Participants | 80 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 15 Participants | 10 Participants | 6 Participants | 21 Participants | 80 Participants |
| Sex: Female, Male Male | 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 15 | 0 / 10 | 0 / 6 | 0 / 21 |
| other Total, other adverse events | 13 / 14 | 13 / 14 | 13 / 15 | 7 / 10 | 4 / 6 | 17 / 21 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 15 | 0 / 10 | 0 / 6 | 0 / 21 |
Outcome results
Primary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
The number of subjects with any unsolicited AEs from the day of vaccination in study V98\_06E1 to Day 31. An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified.
Time frame: Day 1 to Day 31
Population: All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | At least possibly or probably related AEs | 1 Participants |
| GBS NoAdj/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 4 Participants |
| GBS Alum/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | At least possibly or probably related AEs | 1 Participants |
| GBS Alum/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 5 Participants |
| GBS MF59 Half/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 4 Participants |
| GBS MF59 Half/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | At least possibly or probably related AEs | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 4 Participants |
| GBS MF59 Full/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | At least possibly or probably related AEs | 0 Participants |
| Placebo/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 4 Participants |
| Placebo/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | At least possibly or probably related AEs | 1 Participants |
| Naive/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | At least possibly or probably related AEs | 1 Participants |
| Naive/GBS NoAdj Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE | 9 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Medically attended adverse event is defined as an adverse event that leads to a visit to a healthcare provider and AEs leading to withdrawal are defined as adverse events leading to study or vaccine withdrawal.
Time frame: Day 1 to Day 181
Population: All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | Medically attended AEs | 5 Participants |
| GBS NoAdj/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | AEs leading to withdrawal | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | SAEs | 0 Participants |
| GBS Alum/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | SAEs | 0 Participants |
| GBS Alum/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | Medically attended AEs | 5 Participants |
| GBS Alum/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | AEs leading to withdrawal | 0 Participants |
| GBS MF59 Half/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | AEs leading to withdrawal | 0 Participants |
| GBS MF59 Half/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | Medically attended AEs | 7 Participants |
| GBS MF59 Half/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | SAEs | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | SAEs | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | AEs leading to withdrawal | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | Medically attended AEs | 0 Participants |
| Placebo/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | SAEs | 0 Participants |
| Placebo/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | Medically attended AEs | 2 Participants |
| Placebo/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | AEs leading to withdrawal | 0 Participants |
| Naive/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | AEs leading to withdrawal | 0 Participants |
| Naive/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | Medically attended AEs | 5 Participants |
| Naive/GBS NoAdj Group | Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal | SAEs | 0 Participants |
Primary
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Threshold for Erythema, Swelling and Induration: None (0 mm), Any (\>= 1 mm).
Time frame: Day 1 to Day 7
Population: All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any solicited adverse event data and/or indicators of solicited adverse events (e.g., use of analgesics/antipyretics).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration | 2 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 3 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Arthralgia | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Warmth | 1 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (≥ 38°C) | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Myalgia | 2 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Chills | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Body Rash | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 5 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Headache | 4 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema | 1 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Pain | 10 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis | 0 Participants |
| GBS NoAdj/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Local | 11 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Warmth | 4 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Arthralgia | 1 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Headache | 4 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema | 4 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (≥ 38°C) | 0 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling | 2 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Myalgia | 2 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration | 2 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis | 0 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Local | 12 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Body Rash | 1 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 11 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Chills | 0 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 2 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 2 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Pain | 9 Participants |
| GBS Alum/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 10 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration | 5 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Body Rash | 0 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema | 2 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (≥ 38°C) | 0 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis | 1 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 4 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Headache | 5 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Myalgia | 2 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 7 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Local | 10 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 2 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Chills | 1 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Arthralgia | 2 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling | 4 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 2 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Warmth | 4 Participants |
| GBS MF59 Half/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Pain | 9 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Warmth | 2 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema | 1 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Chills | 1 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Local | 6 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 4 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (≥ 38°C) | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 2 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Myalgia | 1 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Pain | 6 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling | 1 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Body Rash | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 5 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration | 2 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Headache | 2 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Arthralgia | 0 Participants |
| GBS MF59 Full/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Arthralgia | 0 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Local | 3 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Pain | 3 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema | 1 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling | 1 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Warmth | 2 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration | 1 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis | 0 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 2 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Chills | 1 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 1 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Myalgia | 1 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Headache | 2 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 1 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Body Rash | 0 Participants |
| Placebo/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (≥ 38°C) | 0 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Myalgia | 1 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Malaise | 1 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Nausea | 1 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Body Rash | 0 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fatigue | 2 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 5 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis | 1 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration | 0 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Warmth | 2 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (≥ 38°C) | 0 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling | 0 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema | 3 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Generalized Arthralgia | 0 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Local | 11 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Pain | 11 Participants |
| Naive/GBS NoAdj Group | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Headache | 4 Participants |
Primary
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 92 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 80 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 40 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 40 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 40 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 40 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 40 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 65 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 50 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 80 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 75 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 80 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 65 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 50 Percentage of subjects |
Primary
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 85 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 85 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 93 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 93 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 80 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 20 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.5 μg/mL | 70 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 8 μg/mL | 40 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.1 μg/mL | 85 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 0.2 μg/mL | 80 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 3 μg/mL | 50 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 5 μg/mL | 45 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 2 μg/mL | 50 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 | ≥ 1 μg/mL | 65 Percentage of subjects |
Primary
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).
Time frame: At Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 3 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 5 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 8 µg/mL | 92 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 8 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 5 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 3 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 8 µg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 3 µg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 5 µg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 5 µg/mL | 90 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 3 µg/mL | 90 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 8 µg/mL | 90 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 8 µg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 2 µg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 3 µg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 5 µg/mL | 60 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 1 µg/mL | 80 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 8 µg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 2 µg/mL | 65 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.5 µg/mL | 90 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 1 µg/mL | 85 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 3 µg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.2 µg/mL | 95 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 5 µg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
Secondary
Geometric Mean Antibody Concentrations of GBS Serotype Ib
The Geometric Mean Antibody Concentrations of GBS Serotype Ib in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 1 | 0.19 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 61 | 56.32 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 31 | 80.62 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 61 | 57.82 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 31 | 74.96 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 1 | 0.15 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 31 | 89.59 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 1 | 0.10 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 61 | 59.13 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 31 | 85.90 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 1 | 0.16 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 61 | 65.53 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 31 | 6.61 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 1 | 0.14 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 61 | 5.51 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 1 | 0.17 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 61 | 4.47 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib | Day 31 | 3.55 µg/mL |
Secondary
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 287.34 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 228.26 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 1.96 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 121.26 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 0.52 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 118.94 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 373.02 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 3.42 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 367.26 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 338.80 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 3.12 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 300.10 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 0.82 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 557.46 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 378.70 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 1.92 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 403.16 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 557.03 µg/mL |
Secondary
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ
The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 60.78 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.078 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 40.59 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 69.05 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.078 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 47.71 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.078 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 34.12 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 53.01 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 65.50 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.078 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 47.58 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 1.47 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.078 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 1.32 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 0.79 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 1.19 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.078 µg/mL |
Secondary
Geometric Mean Antibody Concentrations of GBS Serotype III
The Geometric Mean Antibody Concentrations of GBS Serotype III in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 31 | 111.30 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 1 | 0.41 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 61 | 91.30 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 31 | 104.55 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 1 | 0.17 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 61 | 80.94 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 31 | 109.23 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 1 | 0.25 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 61 | 81.71 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 1 | 0.17 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 31 | 216.39 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 61 | 200.78 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 1 | 0.15 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 31 | 2.66 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 61 | 2.67 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 31 | 5.33 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 1 | 0.31 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III | Day 61 | 5.82 µg/mL |
Secondary
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 5.33 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 186.63 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 171.67 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 270.01 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 231.17 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 1.41 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 107.21 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 1.07 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 120.00 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 0.74 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 149.93 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 180.29 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 1 | 2.79 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 61 | 116.43 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Day 31 | 136.68 µg/mL |
Secondary
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ
The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 109.31 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.15 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 83.19 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 77.97 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.15 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 60.01 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 126.89 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.15 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 87.40 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 188.63 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.15 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 169.45 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 1.90 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.15 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 1.92 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 1 | 0.15 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 61 | 2.52 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ | Day 31 | 2.12 µg/mL |
Secondary
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia
The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in All Subjects were estimated for at Day 1, Day 31 and Day 61.
Time frame: At Day 1, Day 31 and Day 61.
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 31 | 61.13 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 61 | 51.53 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 1 (V98_06E1) | 9.32 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 61 | 65.30 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 31 | 81.61 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 1 (V98_06E1) | 5.50 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 1 (V98_06E1) | 3.44 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 31 | 64.19 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 61 | 44.69 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 1 (V98_06E1) | 2.18 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 61 | 50.67 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 31 | 57.54 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 1 (V98_06E1) | 1.05 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 31 | 19.25 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 61 | 21.36 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 61 | 10.02 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 1 (V98_06E1) | 0.32 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia | Serotype Ia - Day 31 | 10.06 µg/mL |
Secondary
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 31 | 128.91 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 61 | 112.78 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 1 (V98_06E1) | 64.06 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 31 | 196.32 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 1 (V98_06E1) | 98.43 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 61 | 197.67 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 61 | 107.57 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 1 (V98_06E1) | 29.83 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 31 | 156.26 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 1 (V98_06E1) | 39.57 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 31 | 85.63 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 61 | 93.02 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 31 | 177.38 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 1 (V98_06E1) | 5.76 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 61 | 151.27 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 1 (V98_06E1) | 2.54 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 61 | 131.48 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ | Serotype Ia - Day 31 | 161.99 µg/mL |
Secondary
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ)
The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61.
Time frame: At Day 1, Day 31 and Day 61
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 31 | 32.25 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 1 (V98_06E1) | 1.36 µg/mL |
| GBS NoAdj/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 61 | 26.33 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 31 | 62.54 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 1 (V98_06E1) | 2.59 µg/mL |
| GBS Alum/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 61 | 49.01 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 31 | 35.47 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 1 (V98_06E1) | 0.81 µg/mL |
| GBS MF59 Half/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 61 | 24.89 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 31 | 46.11 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 1 (V98_06E1) | 1.12 µg/mL |
| GBS MF59 Full/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 61 | 39.56 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 31 | 6.34 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 1 (V98_06E1) | 0.45 µg/mL |
| Placebo/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 61 | 5.79 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 1 (V98_06E1) | 0.16 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 61 | 4.25 µg/mL |
| Naive/GBS NoAdj Group | Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) | Serotype Ia - Day 31 | 3.98 µg/mL |
Secondary
Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects
Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations (95%CI) in All Subjects at Day 1 Pre-vaccination in the V98\_06 study or V98\_06E1 for the Naive Group and at Day 61 Post-vaccination in Study V98\_06E1. Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other Cross Reactive Material(CRM)-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations.
Time frame: At Day 1 (V98_06 or V98_06E1) and Day 61
Population: Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other CRM-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations.
Secondary
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 31
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 92 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 85 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 93 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 93 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 93 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 83 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 50 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 50 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 50 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 50 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 83 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 75 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 45 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 45 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 45 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 70 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 45 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 45 Percentage of subjects |
Secondary
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time frame: At Day 31
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 92 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 67 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 50 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 33 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 33 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 33 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 67 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 50 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 5 μg/mL | 55 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 2 μg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.5 μg/mL | 70 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 3 μg/mL | 55 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 1 μg/mL | 65 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.2 μg/mL | 75 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 8 μg/mL | 50 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 | ≥ 0.1 μg/mL | 100 Percentage of subjects |
Secondary
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31
Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 31 post-vaccination, as measured by ELISA.
Time frame: At Day 31
Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 3 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 5 µg/mL | 100 Percentage of subjects |
| GBS NoAdj/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 8 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 8 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 5 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 3 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| GBS Alum/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 8 µg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 3 µg/mL | 100 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 5 µg/mL | 93 Percentage of subjects |
| GBS MF59 Half/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 5 µg/mL | 90 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 3 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 2 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 1 µg/mL | 100 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 8 µg/mL | 90 Percentage of subjects |
| GBS MF59 Full/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 8 µg/mL | 67 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.1 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 2 µg/mL | 67 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 3 µg/mL | 67 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 5 µg/mL | 67 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.2 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.5 µg/mL | 100 Percentage of subjects |
| Placebo/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 1 µg/mL | 83 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 8 µg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 2 µg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.5 µg/mL | 80 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 1 µg/mL | 75 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 3 µg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.2 µg/mL | 85 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 5 µg/mL | 60 Percentage of subjects |
| Naive/GBS NoAdj Group | Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 | ≥ 0.1 µg/mL | 100 Percentage of subjects |