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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020840-36 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B Streptococcus Trivalent Vaccine | Experimental | Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine. |
|
| Placebo | Placebo Comparator | Pregnant women who received one injection of saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group B Streptococcus Trivalent Vaccine | Biological | Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day of delivery/birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1, day 31 and day 91 post-delivery |
Not provided
Inclusion 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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Gilbert Donders, Prof. | Regional Hospital Heilig Hart, Tienen, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Herestraat | Leuven | 49-B-3000 | Belgium | ||
| Regionaal Ziekenhuis Heilig Hart, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29374589 | Derived | 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. | |
| 26942345 |
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A total of 86 pregnant subjects were enrolled in the study. 86 infants were enrolled in this study, delivered by 86 maternal subjects. There were 86 singleton deliveries.
Participants were recruited from 5 centres.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mothers GBS | Pregnant women who received one injection of GBS vaccine. |
| FG001 | Mothers Placebo | Pregnant women who received one injection of saline solution. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Biological | Pregnant women who received one injection of saline solution administered intramuscularly. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | From birth until study termination |
| 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 |
| Derived |
| 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. |
| FG002 | Infants GBS | Infants born from mothers who received one injection of GBS vaccine. |
| FG003 | Infants Placebo | Infants born from mothers who received one injection of saline solution. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mothers GBS | Pregnant women who received one injection of GBS vaccine. |
| BG001 | Mothers Placebo | Pregnant women who received one injection of saline solution. |
| BG002 | Infants GBS | Infants born from mothers who received one injection of GBS vaccine. |
| BG003 | Infants Placebo | Infants born from mothers who received one injection of saline solution. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Analysis was done on the enrolled population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Continuous | Analysis was done on the enrolled population. | Mean | Standard Deviation | days |
| ||||||||||||||
| Sex: Female, Male | Analysis was done on the enrolled population. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day of delivery/birth |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | The analysis was done on the Immunogenicity PPS. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day of delivery/birth |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Immunogenicity PPS. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day 1, day 31 and day 91 post-delivery |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Immunogenicity PPS. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 31, day of delivery, day 91 post-delivery | strains | Participants |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Immunogenicity PPS. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Day of birth and day 91 after birth |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Immunogenicity PPS. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 91 after birth |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Immunogenicity PPS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | 1 month after the last routine infant immunization |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Safety Set, ie, all subjects in the enrolled population who received a study vaccination, provided post vaccination safety data, provided post-baseline safety data. | Posted | Number | Percentages of subjects | From day 1 to 7 after vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Safety Set. | Posted | Number | Percentages of subjects | 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. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was done on the Safety Set. | Posted | Number | Percentages of subjects | From birth until study termination |
|
|
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).
The analysis was done on the Safety Set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mothers GBS | Pregnant women who received one dose of GBS vaccine. | 7 | 51 | 35 | 51 | ||
| EG001 | Mothers Placebo | Pregnant women who received one injection of saline solution. | 8 | 35 | 24 | 35 | ||
| EG002 | Infants GBS | Infants born from mothers who received one dose of GBS vaccine. | 12 | 51 | 0 | 51 | ||
| EG003 | Infants Placebo | Infants born from mothers who received one injection of saline solution. | 11 | 35 | 2 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal hypoplasia | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Jaundice acholuric | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Cataract congenital | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Renal dysplasia | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Crying | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Post procedural haemorrage | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Brachial plexus injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Foetal monitoring | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Feeding disorder | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Arrested labour | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Placental insufficiency | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Umbilical cord prolapse | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Unstable foetal lie | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Postpartum depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Renal hypertrophy | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Cervix disorder | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Vaginal haemorrage | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tachipnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Caesarean section | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Postpartum depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Vaginal haemorrage | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis vaccines | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| Male |
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| Belgium |
|
| GBS Ib (N=40, 22, 40, 22) |
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| GBS III (N=40, 25, 40, 25) |
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| strains |
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