Streptococcal InfectionPhase 2NCT01446289

Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

A Phase 2 study testing Group B Streptococcus Trivalent Vaccine in people with Streptococcal Infection and Gram-positive Bacterial Infection, run by Novartis at 5 sites in 2 countries.

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 study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
What is being tested?: Group B Streptococcus Trivalent Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 5 sitesin 2 countries
Study dates: Sep 2011to Oct 2013
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 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening.
Individuals who have given a written consent after the nature of the study has been explained according to local regulatory requirements.
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Individuals who will be available for all scheduled visits (ie, not planning to leave the area before the end of the study period).

Who cannot join

Individuals who were unwilling and/or unable to give written informed consent to participate in the study.
Individuals with a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
Individuals with any known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from:
receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 15 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy).
receipt of immunostimulants.
receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within 12 weeks prior to enrollment and for the full length of the study.

Show all 23Show fewer

Note: Anti-D (Rho) Immunoglobulins (anti-RhD) given for Anti-D prophylaxis were to be allowed.
Individuals characterized as "high risk" pregnancies at investigator discretion, such as those who have:
gestational diabetes
preeclampsia/eclampsia
women at risk of preterm labor (except positivity for vaginal GBS)
History of previous pregnancy complications including delivery of preterm infant.
History of still-birth, late abortions and children with congenital anomalies.
Individuals who had received any other investigational agent or investigational intervention during the course of the study.
Individuals with acute infection including oral temperature ≥ 38°C were to be temporarily excluded. They could be enrolled once the infection had resolved (as judged by investigator).
HIV positive by history.
Individuals reporting any known or suspected serious acute, chronic or progressive disease (eg, any history of neoplasm, malignancy, including lymphoproliferative disorder, diabetes, cardiac disease, malnutrition, renal failure, autoimmune disease, HBV or HCV, blood disorders).
Note: Malignancies, highly likely to having been cured at the investigators discretion are allowed. (eg, no relapse since 5 years post last malignancy specific treatment).
Individuals with bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study (eg, who were not able to comprehend or to follow all required study procedures for the whole period of the study).
Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
Individuals with history or any illness that, in the opinion of the investigator, might have posed additional risk to subjects due to participation in the study.
Individuals who were part of study personnel or close family members conducting this study.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Canada3 sites

Centre hospitalier universitaire de Quebec (CHUQ)- hospital CHUL, Centre de recherche en infectiologie, 2705,
Boulevard Laurier, S-745, Quebec, G1V 4G2
Dalhousie University, IWK Health Centre, 5850/5980 University Avenue,
Halifax, Nova Scotia, B3K 6R8
University of British Columbia, Rm B3 25 B, 4500 Oak Street,
Vancouver, British Columbia, V6H3N1

Other trials in Canada

Belgium2 sites

Regionaal Ziekenhuis Heilig Hart,
Gasthuismolenstraat 31, Tienen, 3300
UZ Leuven
Herestraat, Leuven, 49-B-3000

Other trials in Belgium

About this study

Official title: A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

Conditions: Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
Being tested: Group B Streptococcus Trivalent Vaccine, Placebo
Keywords: Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection
Medical subject headings: Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections

What participants receive

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

Group B Streptococcus Trivalent VaccineBiological
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.
PlaceboBiological
Pregnant women who received one injection of saline solution administered intramuscularly.

Study groups in NCT01446289
Study group	Role	What they receive
Group B Streptococcus Trivalent Vaccine	Experimental	Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine. Receives: Biological: Group B Streptococcus Trivalent Vaccine
Placebo	Placebo comparator	Pregnant women who received one injection of saline solution. Receives: Biological: Placebo

What is being measured

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

Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth
GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Measured: Day of delivery/birth
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery
The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
Measured: Day of delivery/birth

Secondary outcomes (8)

GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects
GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.
Measured: Day 1, day 31 and day 91 post-delivery
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects
GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.
Measured: Day 31, day of delivery, day 91 post-delivery
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants
GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.
Measured: Day of birth and day 91 after birth
GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth
GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.
Measured: Day 91 after birth
Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization
Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.
Measured: 1 month after the last routine infant immunization
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.
Measured: From day 1 to 7 after vaccination
Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)
Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician's visit, AEs leading to withdrawal are reported.
Measured: All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician's visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.
Percentages of Infants Reporting SAEs
Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.
Measured: From birth until study termination

Timeline

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

Sep 2011Oct 2013

First posted5 Oct 2011 (estimated)
Study startSep 2011
Primary completionApr 2013
Study completionOct 2013

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 (2)Papers the sponsor has linked to this study.
Other trials for Streptococcal InfectionStudies 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: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01446289
Sponsor's protocol ID: V98_04
Other IDs: 2010-020840-36
Status last verified: Sep 2014
First submitted: 27 Sep 2011
Last updated: 8 Sep 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Fabbrini M, Rigat F, Tuscano G, Chiarot E, Donders G, Devlieger R, Filippini S, Frigimelica E, Forte P, Wittke F, Halperin SA, Slobod K, Grandi G, Margarit I. Functional activity of maternal and cord antibodies elicited by an investigational group B Streptococcus trivalent glycoconjugate vaccine in pregnant women. J Infect. 2018 May;76(5):449-456. doi: 10.1016/j.jinf.2018.01.006. Epub 2018 Jan 31.
PubMed 29374589
Donders GG, Halperin SA, Devlieger R, Baker S, Forte P, Wittke F, Slobod KS, Dull PM. Maternal Immunization With an Investigational Trivalent Group B Streptococcal Vaccine: A Randomized Controlled Trial. Obstet Gynecol. 2016 Feb;127(2):213-21. doi: 10.1097/AOG.0000000000001190.
PubMed 26942345

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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All Streptococcal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
ClinicalTrials.gov ID: NCT01446289
Acronym / sponsor ID: V98_04
Conditions: Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
Keywords: Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Sep 2011
Primary completion: Apr 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 5 Oct 2011 (estimated)
Results: Posted 8 Sep 2014

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: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Group B Streptococcus Trivalent Vaccine	Experimental	Biological: Group B Streptococcus Trivalent VaccinePregnant women who received one injection of Group B Streptococcus Trivalent Vaccine.
Placebo	Placebo comparator	Biological: PlaceboPregnant women who received one injection of saline solution.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening.
Individuals who have given a written consent after the nature of the study has been explained according to local regulatory requirements.
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Individuals who will be available for all scheduled visits (ie, not planning to leave the area before the end of the study period).

Key exclusion criteria (23 listed)

Individuals who were unwilling and/or unable to give written informed consent to participate in the study.
Individuals with a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
Individuals with any known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from:
Note: Anti-D (Rho) Immunoglobulins (anti-RhD) given for Anti-D prophylaxis were to be allowed.
Individuals characterized as "high risk" pregnancies at investigator discretion, such as those who have:

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
Group B Streptococcus Trivalent VaccinePregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.	Biological	Group B Streptococcus Trivalent Vaccine
PlaceboPregnant women who received one injection of saline solution administered intramuscularly.	Biological	Placebo

Primary outcome

Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth
Time frame: Day of delivery/birth
GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery
Time frame: Day of delivery/birth
The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.

8 secondary outcomes

GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects
Time frame: Day 1, day 31 and day 91 post-delivery
Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects
Time frame: Day 31, day of delivery, day 91 post-delivery
GMC (ELISA) of Anti-GBS CPS Antibodies in Infants
Time frame: Day of birth and day 91 after birth
GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth
Time frame: Day 91 after birth
Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization
Time frame: 1 month after the last routine infant immunization
Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Time frame: From day 1 to 7 after vaccination
Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)
Time frame: All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician's visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.
Percentages of Infants Reporting SAEs
Time frame: From birth until study termination

Results and safety

Results posted to the registry on 8 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mothers GBS	51	50
Mothers Placebo	35	35
Infants GBS	51	50
Infants Placebo	35	35

Primary outcome: Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth

Time frame: Day of delivery/birth. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	Mothers GBS n = 45	Mothers Placebo n = 30	Infants GBS n = 45	Infants Placebo n = 30
GBS Ia	5.39 (2.97 to 9.77)	0.41 (0.2 to 0.85)	4.37 (2.39 to 7.99)	0.4 (0.19 to 0.83)
GBS Ib (N=40, 22, 40, 22)	3.35 (1.44 to 7.77)	0.064 (0.021 to 0.19)	2.59 (1.14 to 5.87)	0.092 (0.032 to 0.27)
GBS III (N=40, 25, 40, 25)	2.45 (1.15 to 5.2)	0.056 (0.022 to 0.14)	1.65 (0.78 to 3.5)	0.055 (0.022 to 0.14)

Population analysed: The analysis was done on the Immunogenicity Per Protocol Set (PPS), ie: all subjects in the enrolled population who correctly received the vaccine, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to un-blinding.

Primary outcome: Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery

Time frame: Day of delivery/birth. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Mothers GBS n = 45	Mothers Placebo n = 30
GBS Ia	0.81 (0.72 to 0.91)	0.97 (0.85 to 1.11)
GBS Ib (N=40, 22)	0.77 (0.62 to 0.97)	1.44 (1.06 to 1.94)
GBS III (N=40, 25)	0.68 (0.59 to 0.78)	0.99 (0.83 to 1.18)

Population analysed: The analysis was done on the Immunogenicity PPS.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mothers GBS	7 of 51 (13.7%)	35 of 51 (68.6%)	Not reported
Mothers Placebo	8 of 35 (22.9%)	24 of 35 (68.6%)	Not reported
Infants GBS	12 of 51 (23.5%)	0 of 51 (0%)	Not reported
Infants Placebo	11 of 35 (31.4%)	2 of 35 (5.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29374589Fabbrini M, Rigat F, Tuscano G, Chiarot E, Donders G, Devlieger R, Filippini S, Frigimelica E, Forte P, Wittke F, Halperin SA, Slobod K, Grandi G, Margarit I. Functional activity of maternal and cord antibodies elicited by an investigational group B Streptococcus trivalent glycoconjugate vaccine in pregnant women. J Infect. 2018 May;76(5):449-456. doi: 10.1016/j.jinf.2018.01.006. Epub 2018 Jan 31.
Derived from this study: PubMed 26942345Donders GG, Halperin SA, Devlieger R, Baker S, Forte P, Wittke F, Slobod KS, Dull PM. Maternal Immunization With an Investigational Trivalent Group B Streptococcal Vaccine: A Randomized Controlled Trial. Obstet Gynecol. 2016 Feb;127(2):213-21. doi: 10.1097/AOG.0000000000001190.

Related trials for Streptococcal Infection

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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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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.

Novartis Vaccines study chair

Novartis Vaccines

Gilbert Donders, Prof. principal investigator

Regional Hospital Heilig Hart, Tienen, Belgium

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Group B Streptococcus Trivalent Vaccine in people with Streptococcal Infection and Gram-positive Bacterial Infection, run by Novartis at 5 sites in 2 countries.

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 23 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 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada, 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. Some participants in this study may receive a placebo. 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 8 Sep 2014). 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?

Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth (time frame: Day of delivery/birth). The study lists 2 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 NCT01446289, which also lists 2 linked publications.

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 8 Sep 2014.