CompletedNCT01446289Updated Sep 8, 2014Results posted

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

A Phase 2 interventional study of Group B Streptococcus Trivalent Vaccine and Placebo in Streptococcal Infection, Gram-positive Bacterial Infection and Bacterial Infection, sponsored by Novartis. Completed at 5 sites in 2 countries. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-08.

Sponsored by Novartis · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 86
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: Female

Study 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.

Conditions studied

Streptococcal Infection
Gram-positive Bacterial Infection
Bacterial Infection

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Keywords

Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 86 is below the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 86 participants (actual)

Study arms

Experimental
Group B Streptococcus Trivalent Vaccine
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine.
Biological: Group B Streptococcus Trivalent Vaccine
Placebo comparator
Placebo
Pregnant women who received one injection of saline solution.
Biological: Placebo

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Day of delivery/birth

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: From birth until study termination

Results

Posted Sep 8, 2014

Participant flow

Participants were recruited from 5 centres.

Participant flow — Overall Study
Milestone	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo
Started	51	35	51	35
Completed	50	35	50	35
Not completed	1	0	1	0
Withdrew: Withdrawal by subject	1	0	1	0

Outcome measures

PrimaryGeometric 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.

Time frame:: Day of delivery/birth
Reported as:: Geometric mean · µg/mL

Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth
µg/mL	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo
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)

PrimaryGeometric 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.

Time frame:: Day of delivery/birth
Reported as:: Geometric mean · Ratio

Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery
Ratio	Mothers GBS	Mothers Placebo
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)

SecondaryGMCs (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.

Time frame:: Day 1, day 31 and day 91 post-delivery
Reported as:: Geometric mean · µg/mL

GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects
µg/mL	Mothers GBS	Mothers Placebo
GBS Ia (day 1)	0.28 (0.19 to 0.41)	0.37 (0.24 to 0.58)
GBS Ia (day 31; N=49, 32)	4.83 (2.89 to 8.06)	0.36 (0.19 to 0.65)
GBS Ia (day 91 post-delivery; N = 44, 34)	5.89 (3.86 to 8.99)	0.46 (0.29 to 0.75)
GBS Ib (day 1; N= 50, 34)	0.13 (0.084 to 0.19)	0.084 (0.051 to 0.14)
GBS Ib (day 31; N=49, 31)	1.68 (0.97 to 2.92)	0.14 (0.069 to 0.27)
GBS Ib (day 91 post-delivery; N= 44, 33)	3.46 (2.33 to 5.14)	0.17 (0.11 to 0.27)
GBS III (day 1)	0.11 (0.07 to 0.16)	0.093 (0.056 to 0.15)
GBS III (day 31; N= 49, 32)	1.46 (0.83 to 2.57)	0.12 (0.06 to 0.23)
GBS III (day 91 post-delivery; N=44, 34)	2.69 (1.78 to 4.06)	0.11 (0.07 to 0.18)

SecondaryGeometric 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.

Time frame:: Day 31, day of delivery, day 91 post-delivery
Reported as:: Geometric mean · Ratio

Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects
Ratio	Mothers GBS	Mothers Placebo
GBS Ia (Day 31/day 1; N=49, 32)	15 (9.12 to 25)	1.22 (0.66 to 2.25)
GBS Ia (Delivery/day 1)	16 (11 to 25)	1.2 (0.72 to 2.01)
GBS Ia (day 91 post-delivery/day 1; N= 44, 34)	19 (12 to 28)	1.51 (0.94 to 2.42)
GBS Ib (Day 31/day 1; N=48, 30)	18 (9.94 to 32)	1.14 (0.56 to 2.35)
GBS Ib (Delivery/day 1; N=50, 34)	23 (14 to 39)	1.13 (0.63 to 2.05)
GBS Ib (day 91 post-delivery/day 1; N=44, 32)	33 (22 to 48)	1.53 (0.96 to 2.43)
GBS III (Day 31/day 1; N=49, 32)	17 (9.17 to 30)	1.19 (0.59 to 2.42)
GBS III (Delivery/day 1)	20 (12 to 33)	1.08 (0.6 to 1.96)
GBS III (day 91 post-delivery/day 1; N=44, 34)	28 (18 to 43)	1.11 (0.69 to 1.8)

SecondaryGMC (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.

Time frame:: Day of birth and day 91 after birth
Reported as:: Geometric mean · μg/mL

GMC (ELISA) of Anti-GBS CPS Antibodies in Infants
μg/mL	Infants GBS	Infants Placebo
GBS Ia (day of birth)	5.14 (2.64 to 10)	0.33 (0.15 to 0.71)
GBS Ia (day 91 after birth)	1.28 (0.76 to 2.16)	0.25 (0.13 to 0.46)
GBS Ib (day of birth; N=31, 20)	2.93 (1.14 to 7.57)	0.1 (0.031 to 0.32)
GBS Ib (day 91 after birth)	0.54 (0.25 to 1.19)	0.063 (0.025 to 0.16)
GBS III (day of birth; N=30, 22)	1.93 (0.82 to 4.59)	0.065 (0.024 to 0.18)
GBS III (day 91 after birth)	0.43 (0.21 to 0.86)	0.065 (0.029 to 0.15)

SecondaryGMRs 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.

Time frame:: Day 91 after birth
Reported as:: Geometric mean · Ratio

GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth
Ratio	Infants GBS	Infants Placebo
GBS Ia	0.25 (0.19 to 0.32)	0.76 (0.57 to 1.01)
GBS Ib (N=31, 20 )	0.22 (0.16 to 0.29)	0.54 (0.38 to 0.78)
GBS III (N=30, 22)	0.25 (0.19 to 0.32)	0.85 (0.62 to 1.16)

SecondaryPercentages 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.

Time frame:: 1 month after the last routine infant immunization
Reported as:: Number · Percentages of subjects

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 subjects	Infants GBS	Infants Placebo
Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization	100 (91 to 100)	100 (87 to 100)

SecondaryPercentage 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.

Time frame:: From day 1 to 7 after vaccination
Reported as:: Number · Percentages of subjects

Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Percentages of subjects	Mothers GBS	Mothers Placebo
Any local	40	24
Induration (>=25 mm; N =49, 34)	6	0
Swelling (>=25 mm; N =49, 34)	4	0
Ecchymosis (>=25 mm; N =49, 34 )	2	0
Erythema (>=25 mm; N =49, 34)	6	0
Pain (N =49, 34)	35	12
Any systemic	46	38
Chills (N =49, 34)	4	3
Fatigue (N =49, 34)	31	26
Malaise (N =49, 34)	14	9
Myalgia (N =49, 34)	27	3
Headache (N =49, 34)	16	21
Rash (N =49, 34)	2	3
Arthralgia (N =49, 34)	4	9
Nausea (N =49, 34)	6	9
Fever, body temperature >38° C (N =49, 33)	0	0
Any other	8	3
Stayed home (N =49, 34)	2	0
Use of analgesics/antipyretics (N =49, 34)	6	3

SecondaryPercentage 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.

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.
Reported as:: Number · Percentages of subjects

Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)
Percentages of subjects	Mothers GBS	Mothers Placebo
Any unsolicited AE	63	74
Any SAE	14	23
Medically-attended AEs	51	54
AEs leading to withdrawal	0	0

SecondaryPercentages 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.

Time frame:: From birth until study termination
Reported as:: Number · Percentages of subjects

Percentages of Infants Reporting SAEs
Percentages of subjects	Infants GBS	Infants Placebo
Percentages of Infants Reporting SAEs	24	31

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Mothers GBS	—	7/51 (13.7%)	35/51 (68.6%)
Mothers Placebo	—	8/35 (22.9%)	24/35 (68.6%)
Infants GBS	—	12/51 (23.5%)	0/51 (0%)
Infants Placebo	—	11/35 (31.4%)	2/35 (5.7%)

Most frequent serious events

Showing 10 of 54

Most frequent serious events
Event	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo
Premature labourPregnancy, puerperium and perinatal conditions	0/51	2/35	0/51	0/35
Jaundice acholuricBlood and lymphatic system disorders	0/51	0/35	0/51	1/35
Cataract congenitalCongenital, familial and genetic disorders	0/51	0/35	0/51	1/35
Ventricular septal defectCongenital, familial and genetic disorders	0/51	0/35	0/51	1/35
CryingGeneral disorders	0/51	0/35	0/51	1/35
AppendicitisInfections and infestations	0/51	1/35	0/51	0/35
Respiratory syncytial virus infectionInfections and infestations	0/51	0/35	1/51	1/35
Urinary tract infectionInfections and infestations	0/51	0/35	0/51	1/35
Viral infectionInfections and infestations	0/51	0/35	1/51	1/35
Post procedural haemorrageInjury, poisoning and procedural complications	0/51	1/35	0/51	0/35

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo
Injection site painGeneral disorders	18/51	8/35	0/51	0/35
FatigueGeneral disorders	15/51	10/35	0/51	0/35
HeadacheNervous system disorders	8/51	10/35	0/51	0/35
MyalgiaMusculoskeletal and connective tissue disorders	13/51	1/35	0/51	0/35
Injection site erythemaGeneral disorders	9/51	4/35	0/51	0/35
NauseaGastrointestinal disorders	4/51	5/35	0/51	0/35
MalaiseGeneral disorders	7/51	4/35	0/51	0/35
Injection site indurationGeneral disorders	6/51	1/35	0/51	0/35
HaemorrhoidsGastrointestinal disorders	0/51	3/35	0/51	0/35
Injection site haemorrhageGeneral disorders	2/51	3/35	0/51	0/35

Baseline characteristics

All enrolled population

Age, Continuous
Age, Continuous(years)	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo	Total
Mean	29.7 ± 4.9	30 ± 5.5	NA ± NA	NA ± NA	29.8 ± 5.1

Age, Continuous
Age, Continuous(days)	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo	Total
Mean	NA ± NA	NA ± NA	0 ± 0	0 ± 0	0 ± 0

Sex: Female, Male
Sex: Female, Male(Participants)	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo	Total
Female	51	35	21	15	122
Male	0	0	30	20	50

Region of Enrollment
Region of Enrollment(participants)	Mothers GBS	Mothers Placebo	Infants GBS	Infants Placebo	Total
Canada	15	11	15	11	52
Belgium	36	24	36	24	120

Study locations

5 sites

UZ Leuven
Herestraat, Leuven 49-B-3000, Belgium
Regionaal Ziekenhuis Heilig Hart,
Gasthuismolenstraat 31, Tienen 3300, Belgium
University of British Columbia, Rm B3 25 B, 4500 Oak Street,
Vancouver, British Columbia V6H3N1, Canada
Dalhousie University, IWK Health Centre, 5850/5980 University Avenue,
Halifax, Nova Scotia B3K 6R8, Canada
Centre hospitalier universitaire de Quebec (CHUQ)- hospital CHUL, Centre de recherche en infectiologie, 2705,
Boulevard laurier, S-745, Quebec G1V 4G2, Canada

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01446289
Lead sponsor: Novartis
Collaborators: Novartis Vaccines
Responsible party: Sponsor
First posted: Oct 5, 2011
Start date: Sep 2011
Primary completion: Apr 2013
Completion: Oct 2013
Results posted: Sep 8, 2014
Last update: Sep 8, 2014

Study contacts

Novartis Vaccines

study chair · Novartis Vaccines

Gilbert Donders, Prof.

principal investigator · Regional Hospital Heilig Hart, Tienen, Belgium

View the source record on ClinicalTrials.gov ↗

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