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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003094-15 | EudraCT Number | ||
| V98_06E1 | Other Identifier | Novartis |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBS NoAdj/GBS NoAdj | Experimental | 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). |
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| GBS Alum/GBS NoAdj | Experimental | 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). |
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| GBS MF59 Full/GBS NoAdj | Experimental | 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). |
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| GBS MF59 Half/GBS NoAdj | Experimental | 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). |
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| Placebo/GBS NoAdj | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBS Trivalent Vaccine | Biological | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Day 61 |
| 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. | At Day 61 |
| 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. | At Day 61 |
| Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm). | Day 1 to Day 7 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 31 |
| Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31394574 | Background | Leroux-Roels G, Bebia Z, Maes C, Aerssens A, De Boever F, Grassano L, Buffi G, Margarit I, Karsten A, Cho S, Slobod K, Corsaro B, Henry O. Safety and Immunogenicity of a Second Dose of an Investigational Maternal Trivalent Group B Streptococcus Vaccine in Nonpregnant Women 4-6 Years After a First Dose: Results From a Phase 2 Trial. Clin Infect Dis. 2020 Jun 10;70(12):2570-2579. doi: 10.1093/cid/ciz737. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
All enrolled subjects completed the study.
Subjects were recruited from 1 site in Belgium.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | GBS Alum/GBS NoAdj Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2015 |
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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). |
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| Naive/GBS NoAdj | Experimental | 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). |
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| Day 1 to Day 31 |
| 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. | Day 1 to Day 181 |
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. |
| At Day 31 |
| 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. | At Day 31 |
| 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. | At Day 1, Day 31 and Day 61. |
| 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. | At Day 1, Day 31 and Day 61 |
| 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. | At Day 1, Day 31 and Day 61 |
| 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. | 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 | 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. | At Day 1, Day 31 and Day 61 |
| 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. | At Day 1, Day 31 and Day 61 |
| 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. | At Day 1, Day 31 and Day 61 |
| 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. | At Day 1, Day 31 and Day 61 |
| 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. | At Day 1, Day 31 and Day 61 |
| 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. | At Day 1 (V98_06 or V98_06E1) and Day 61 |
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). |
| FG002 | 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). |
| FG003 | 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). |
| FG004 | 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). |
| FG005 | 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). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | 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). |
| BG005 | 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). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 61 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 61 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 61 |
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| Primary | Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm). | 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). | Posted | Count of Participants | Participants | Day 1 to Day 7 |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 31 |
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| 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. | 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. | Posted | Count of Participants | Participants | Day 1 to Day 181 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 31 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 31 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 31 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61. |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Day 1, Day 31 and Day 61 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | At Day 1 (V98_06 or V98_06E1) and Day 61 |
|
Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 14 | 0 | 14 | 13 | 14 |
| EG001 | 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). | 0 | 14 | 0 | 14 | 13 | 14 |
| EG002 | 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). | 0 | 15 | 0 | 15 | 13 | 15 |
| EG003 | 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). | 0 | 10 | 0 | 10 | 7 | 10 |
| EG004 | 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). | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | 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). | 0 | 21 | 0 | 21 | 17 | 21 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear disorder | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctival irritation | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hangover | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| Jan 11, 2019 |
| Prot_SAP_000.pdf |
| Male |
|
| ≥ 0.2 µg/mL |
|
| ≥ 0.5 µg/mL |
|
| ≥ 1 µg/mL |
|
| ≥ 2 µg/mL |
|
| ≥ 3 µg/mL |
|
| ≥ 5 µg/mL |
|
| ≥ 8 µg/mL |
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG002 | 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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG002 | 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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
| OG002 |
| 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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
| OG002 |
| 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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
|
|
| OG002 |
| 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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
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| OG002 |
| 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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
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| OG002 | 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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
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