Bacterial Infection Due to Streptococcus, Group BPhase 2NCT02690181

Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.

A Phase 2 study testing GBS Trivalent Vaccine in people with Bacterial Infection Due to Streptococcus, Group B and Streptococcus Agalactiae, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 to 46 years, women onlyHealthy volunteers can take part
Conditions the study is for: Bacterial Infection Due to Streptococcus, Group B, Streptococcus Agalactiae
What is being tested?: GBS Trivalent Vaccine
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteBelgium
Study dates: 29 Mar 2016to 2 Nov 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 46 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

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.

Conditions: Bacterial Infection Due to Streptococcus, Group B, Streptococcus Agalactiae
Being tested: GBS Trivalent Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GBS Trivalent VaccineBiological
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 .

Study groups in NCT02690181
Study group	Role	What they receive
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). Receives: Biological: GBS Trivalent Vaccine
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). Receives: Biological: GBS Trivalent Vaccine
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). Receives: Biological: GBS Trivalent Vaccine
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). Receives: Biological: GBS Trivalent Vaccine
Placebo/GBS NoAdj	Experimental	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). Receives: Biological: GBS Trivalent Vaccine
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). Receives: Biological: GBS Trivalent Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 1 to Day 181

Secondary outcomes (13)

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.
Measured: At Day 31
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 1 (V98_06 or V98_06E1) and Day 61

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 20162 Nov 2016

First posted24 Feb 2016 (estimated)
Study start29 Mar 2016
Primary completion2 Nov 2016
Study completion2 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bacterial Infection Due to Streptococcus, Group BStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02690181
Sponsor's protocol ID: 205421
Other IDs: 2015-003094-15, V98_06E1, 2015
Status last verified: Mar 2024
First submitted: 16 Feb 2016
Last updated: 4 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

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.
PubMed 31394574

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
Group B Streptococcal Infections
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Invasive Group B Streptococcus Disease, Group B Streptococcus

All Bacterial Infection Due to Streptococcus, Group B trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02690181
Acronym / sponsor ID: 205421
Conditions: Bacterial Infection Due to Streptococcus, Group B, Streptococcus Agalactiae
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 29 Mar 2016 (actual)
Primary completion: 2 Nov 2016 (actual)
Study completion: 2 Nov 2016 (actual)
First posted: 24 Feb 2016 (estimated)
Results: Posted 16 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
GBS NoAdj/GBS NoAdj	Experimental	Biological: GBS Trivalent VaccineSubjects 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).
GBS Alum/GBS NoAdj	Experimental	Biological: GBS Trivalent VaccineSubjects 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).
GBS MF59 Full/GBS NoAdj	Experimental	Biological: GBS Trivalent VaccineSubjects 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).
GBS MF59 Half/GBS NoAdj	Experimental	Biological: GBS Trivalent VaccineSubjects 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).
Placebo/GBS NoAdj	Experimental	Biological: GBS Trivalent VaccineSubjects 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).
Naive/GBS NoAdj	Experimental	Biological: GBS Trivalent VaccineHealthy 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).

Who may qualify

Ages: 22 to 46 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GBS Trivalent VaccineAdministration 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 .	Biological	GBS Alum/GBS NoAdj, GBS MF59 Full/GBS NoAdj, GBS MF59 Half/GBS NoAdj, GBS NoAdj/GBS NoAdj, Naive/GBS NoAdj, Placebo/GBS NoAdj

Primary outcome

Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.

13 secondary outcomes

Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31
Time frame: At Day 31
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31
Time frame: At Day 31
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31
Time frame: At Day 31
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia
Time frame: At Day 1, Day 31 and Day 61.
Geometric Mean Antibody Concentrations of GBS Serotype Ib
Time frame: At Day 1, Day 31 and Day 61
Geometric Mean Antibody Concentrations of GBS Serotype III
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Day 1, Day 31 and Day 61
Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects
Time frame: At Day 1 (V98_06 or V98_06E1) and Day 61

Results and safety

Results posted to the registry on 16 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GBS NoAdj/GBS NoAdj Group	14	14
GBS Alum/GBS NoAdj Group	14	14
GBS MF59 Half/GBS NoAdj Group	15	15
GBS MF59 Full/GBS NoAdj Group	10	10
Placebo/GBS NoAdj Group	6	6
Naive/GBS NoAdj Group	21	21

Primary outcome: Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61

Time frame: At Day 61. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	GBS NoAdj/GBS NoAdj Group n = 13	GBS Alum/GBS NoAdj Group n = 14	GBS MF59 Half/GBS NoAdj Group n = 15	GBS MF59 Full/GBS NoAdj Group n = 10	Placebo/GBS NoAdj Group n = 5	Naive/GBS NoAdj Group n = 20
≥ 0.1 µg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	100 (47.8 to 100)	100 (83.2 to 100)
≥ 0.2 µg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	100 (47.8 to 100)	95 (75.1 to 99.87)
≥ 0.5 µg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	100 (47.8 to 100)	90 (68.3 to 98.8)
≥ 1 µg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	80 (28.4 to 99.5)	85 (62.1 to 96.8)
≥ 2 µg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	60 (14.7 to 94.7)	65 (40.8 to 84.6)
≥ 3 µg/mL	100 (75.3 to 100)	100 (76.8 to 100)	93 (68.1 to 99.83)	90 (55.5 to 99.75)	60 (14.7 to 94.7)	60 (36.1 to 80.9)
≥ 5 µg/mL	100 (75.3 to 100)	100 (76.8 to 100)	93 (68.1 to 99.83)	90 (55.5 to 99.75)	60 (14.7 to 94.7)	60 (36.1 to 80.9)
≥ 8 µg/mL	92 (64 to 99.81)	100 (76.8 to 100)	93 (68.1 to 99.83)	90 (55.5 to 99.75)	60 (14.7 to 94.7)	60 (36.1 to 80.9)

Population analysed: 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.

Primary outcome: Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61

Time frame: At Day 61. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	GBS NoAdj/GBS NoAdj Group n = 13	GBS Alum/GBS NoAdj Group n = 14	GBS MF59 Half/GBS NoAdj Group n = 15	GBS MF59 Full/GBS NoAdj Group n = 10	Placebo/GBS NoAdj Group n = 5	Naive/GBS NoAdj Group n = 20
≥ 0.1 μg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	100 (47.8 to 100)	85 (62.1 to 96.8)
≥ 0.2 μg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	100 (47.8 to 100)	80 (56.3 to 94.3)
≥ 0.5 μg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	80 (28.4 to 99.5)	70 (45.7 to 88.1)
≥ 1 μg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	60 (14.7 to 94.7)	65 (40.8 to 84.6)
≥ 2 μg/mL	100 (75.3 to 100)	100 (76.8 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	60 (14.7 to 94.7)	50 (27.2 to 72.8)
≥ 3 μg/mL	100 (75.3 to 100)	93 (66.1 to 99.82)	100 (78.2 to 100)	100 (69.2 to 100)	60 (14.7 to 94.7)	50 (27.2 to 72.8)
≥ 5 μg/mL	85 (54.6 to 98.1)	93 (66.1 to 99.82)	100 (78.2 to 100)	100 (69.2 to 100)	60 (14.7 to 94.7)	45 (23.1 to 68.5)
≥ 8 μg/mL	85 (54.6 to 98.1)	93 (66.1 to 99.82)	93 (68.1 to 99.83)	100 (69.2 to 100)	20 (0.5 to 71.6)	40 (19.1 to 63.9)

Primary outcome: Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61

Time frame: At Day 61. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	GBS NoAdj/GBS NoAdj Group n = 13	GBS Alum/GBS NoAdj Group n = 13	GBS MF59 Half/GBS NoAdj Group n = 15	GBS MF59 Full/GBS NoAdj Group n = 10	Placebo/GBS NoAdj Group n = 5	Naive/GBS NoAdj Group n = 20
≥ 0.1 μg/mL	100 (75.3 to 100)	100 (75.3 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	100 (47.8 to 100)	100 (83.2 to 100)
≥ 0.2 μg/mL	100 (75.3 to 100)	100 (75.3 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	100 (47.8 to 100)	80 (56.3 to 94.3)
≥ 0.5 μg/mL	100 (75.3 to 100)	100 (75.3 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	80 (28.4 to 99.5)	80 (56.3 to 94.3)
≥ 1 μg/mL	100 (75.3 to 100)	100 (75.3 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	40 (5.3 to 85.3)	75 (50.9 to 91.3)
≥ 2 μg/mL	100 (75.3 to 100)	100 (75.3 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	40 (5.3 to 85.3)	65 (40.8 to 84.6)
≥ 3 μg/mL	100 (75.3 to 100)	100 (75.3 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	40 (5.3 to 85.3)	65 (40.8 to 84.6)
≥ 5 μg/mL	100 (75.3 to 100)	100 (75.3 to 100)	100 (78.2 to 100)	100 (69.2 to 100)	40 (5.3 to 85.3)	50 (27.2 to 72.8)
≥ 8 μg/mL	100 (75.3 to 100)	92 (64 to 99.81)	100 (78.2 to 100)	100 (69.2 to 100)	40 (5.3 to 85.3)	50 (27.2 to 72.8)

Primary outcome: Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)

Time frame: Day 1 to Day 7. Count of participants. Unit: Participants

Measure	GBS NoAdj/GBS NoAdj Group n = 14	GBS Alum/GBS NoAdj Group n = 14	GBS MF59 Half/GBS NoAdj Group n = 15	GBS MF59 Full/GBS NoAdj Group n = 10	Placebo/GBS NoAdj Group n = 5	Naive/GBS NoAdj Group n = 21
Any Local	11	12	10	6	3	11
Pain	10	9	9	6	3	11
Erythema	1	4	2	1	1	3
Swelling	0	2	4	1	1	0
Warmth	1	4	4	2	2	2
Induration	2	2	5	2	1	0
Ecchymosis	0	0	1	0	0	1
Any Systemic	5	11	7	5	2	5

Population analysed: 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).

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GBS NoAdj/GBS NoAdj Group	0 of 14 (0%)	13 of 14 (92.9%)	0 of 14
GBS Alum/GBS NoAdj Group	0 of 14 (0%)	13 of 14 (92.9%)	0 of 14
GBS MF59 Half/GBS NoAdj Group	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15
GBS MF59 Full/GBS NoAdj Group	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Placebo/GBS NoAdj Group	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Naive/GBS NoAdj Group	0 of 21 (0%)	17 of 21 (81%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31394574Leroux-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.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GBS Trivalent Vaccine in people with Bacterial Infection Due to Streptococcus, Group B and Streptococcus Agalactiae, run by GlaxoSmithKline at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 (time frame: At Day 61). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02690181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.