Back to resultsExtension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
Primary Purpose
Bacterial Infection Due to Streptococcus, Group B
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
GBS Trivalent Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Bacterial Infection Due to Streptococcus, Group B
Eligibility Criteria
Inclusion Criteria:
- 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
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
- 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:
- Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
- Abnormal function of the immune system
- Received immunoglobulins or any blood products within 180 days prior to informed consent
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent
- 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
- 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
- Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding
- Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study
- 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
- Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
GBS NoAdj/GBS NoAdj
GBS Alum/GBS NoAdj
GBS MF59 Full/GBS NoAdj
GBS MF59 Half/GBS NoAdj
Placebo/GBS NoAdj
Naive/GBS NoAdj
Arm Description
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).
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).
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).
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).
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).
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).
Outcomes
Primary Outcome Measures
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).
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.
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.
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm).
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02690181
Brief Title
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
Official Title
A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 29, 2016 (Actual)
Primary Completion Date
November 2, 2016 (Actual)
Study Completion Date
November 2, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection Due to Streptococcus, Group B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GBS NoAdj/GBS NoAdj
Arm Type
Experimental
Arm Description
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).
Arm Title
GBS Alum/GBS NoAdj
Arm Type
Experimental
Arm Description
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).
Arm Title
GBS MF59 Full/GBS NoAdj
Arm Type
Experimental
Arm Description
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).
Arm Title
GBS MF59 Half/GBS NoAdj
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo/GBS NoAdj
Arm Type
Experimental
Arm Description
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).
Arm Title
Naive/GBS NoAdj
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
GBS Trivalent Vaccine
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61
Description
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
Title
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61
Description
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
Title
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61
Description
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
Title
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Description
Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm).
Time Frame
Day 1 to Day 7
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description
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
Title
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31
Description
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
Title
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31
Description
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
Title
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31
Description
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
Title
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia
Description
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.
Title
Geometric Mean Antibody Concentrations of GBS Serotype Ib
Description
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
Title
Geometric Mean Antibody Concentrations of GBS Serotype III
Description
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
Title
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)
Description
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
Title
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ
Description
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
Title
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ
Description
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
Title
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
Description
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
Title
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
Description
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
Title
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ
Description
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
Title
Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
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:
Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Abnormal function of the immune system
Received immunoglobulins or any blood products within 180 days prior to informed consent
Received an investigational or non-registered medicinal product within 30 days prior to informed consent
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
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
Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding
Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study
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
Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
IPD Sharing Access Criteria
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
IPD Sharing URL
http://clinicalstudydatarequest.com
Citations:
PubMed Identifier
31394574
Citation
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.
Results Reference
derived
Learn more about this trial
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
We'll reach out to this number within 24 hrs