Invasive Group B Streptococcus DiseaseNCT02099149
Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days
An observational study of Invasive Group B Streptococcus Disease, run by Novartis at 1 site in South Africa.
Trial summary
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Group B Streptococcus Disease
- How many people
- 0 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women aged 18 years or older attending for antenatal care or delivery at 3 academic hospital centers in the Johannesburg area and the antenatal clinics serving those hospital centers.
Who may be able to join
- Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
- Subjects aged ≥18 years.
- Able to understand and comply with planned study procedures.
- Provides written informed consent.
Who cannot join
- Refuses to consent to study participation.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Respiratory and Meningeal Pathogen Research Unit
Soweto, Gauteng, 2013
About this study
Official title: Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less Than 90 Days.
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.
- Conditions
- Invasive Group B Streptococcus Disease
- Keywords
- Group B Streptococcus, early onset disease, late onset disease, anticapsular antibodies, serotype specific
- Medical subject headings
- Late Onset Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Infants born to GBS colonized mother who do not develop GBS disease | |
| Cases | Infants with culture confirmed GBS disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early onset Group B Streptococcus Disease due to serotypes Ia or III
Risk of early onset Group B Streptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery
Measured: 0-6 days
Secondary outcomes (1)
Late onset Group B Streptococcus Disease due to serotype III
Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery
Measured: 7-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Group B Streptococcus DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099149
- Sponsor's protocol ID
- V98_28OB
- Status last verified
- Jul 2014
- First submitted
- 25 Mar 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less Than 90 Days.
- ClinicalTrials.gov ID
- NCT02099149
- Acronym / sponsor ID
- V98_28OB
- Conditions
- Invasive Group B Streptococcus Disease
- Keywords
- Group B Streptococcus, early onset disease, late onset disease, anticapsular antibodies, serotype specific
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- May 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Infants born to GBS colonized mother who do not develop GBS disease |
| Cases | – | –Infants with culture confirmed GBS disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women aged 18 years or older attending for antenatal care or delivery at 3 academic hospital centers in the Johannesburg area and the antenatal clinics serving those hospital centers.
Key inclusion criteria (4 listed)
- Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
- Subjects aged ≥18 years.
- Able to understand and comply with planned study procedures.
- Provides written informed consent.
Key exclusion criteria (1 listed)
- Refuses to consent to study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early onset Group B Streptococcus Disease due to serotypes Ia or III
Time frame: 0-6 days
Risk of early onset Group B Streptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery
1 secondary outcome
Late onset Group B Streptococcus Disease due to serotype III
Time frame: 7-90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Related trials for Invasive Group B Streptococcus Disease
RecruitingObservational study
Preparing for Maternal GBS Vaccine Trials in Africa
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Not yet recruitingObservational study
Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
Invasive Group B Streptococcus Disease, Group B Streptococcus
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.
Novartis Vaccines study chair
Novartis Vaccines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Group B Streptococcus Disease, run by Novartis at 1 site in South Africa.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Jul 2014. 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 South Africa. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Early onset Group B Streptococcus Disease due to serotypes Ia or III (time frame: 0-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2014.