Bacterial Infection, Gram-positive Bacterial Infection, Streptococcal Infection
Conditions
Keywords
Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection
Brief 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.
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.
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening. 2. Individuals who have given a written consent after the nature of the study has been explained according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. 4. 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
1. Individuals who were unwilling and/or unable to give written informed consent to participate in the study. 2. 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. 3. 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. 4. 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. 5. Individuals who had received any other investigational agent or investigational intervention during the course of the study. 6. 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). 7. HIV positive by history. 8. 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). 9. Individuals with bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time. 10. 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). 11. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome. 12. 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. 13. Individuals who were part of study personnel or close family members conducting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | Day of birth and day 91 after birth | 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. |
| GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth | Day 91 after 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. |
| Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization | 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. |
| GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | Day 1, day 31 and day 91 post-delivery | 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. |
| Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | 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. | Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician's visit, AEs leading to withdrawal are reported. |
| Percentages of Infants Reporting SAEs | From birth until study termination | 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. |
| Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | From day 1 to 7 after vaccination | Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported. |
| Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | Day 31, day of delivery, day 91 post-delivery | 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. |
Countries
Belgium, Canada
Participant flow
Recruitment details
Participants were recruited from 5 centres.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Mothers GBS Pregnant women who received one injection of GBS vaccine. | 51 |
| Mothers Placebo Pregnant women who received one injection of saline solution. | 35 |
| Infants GBS Infants born from mothers who received one injection of GBS vaccine. | 51 |
| Infants Placebo Infants born from mothers who received one injection of saline solution. | 35 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Mothers GBS | Mothers Placebo | Infants GBS | Infants Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | NA days | NA days | 0 days STANDARD_DEVIATION 0 | 0 days STANDARD_DEVIATION 0 | 0 days STANDARD_DEVIATION 0 |
| Region of Enrollment Belgium | 36 participants | 24 participants | 36 participants | 24 participants | 120 participants |
| Region of Enrollment Canada | 15 participants | 11 participants | 15 participants | 11 participants | 52 participants |
| Sex: Female, Male Female | 51 Participants | 35 Participants | 21 Participants | 15 Participants | 122 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 30 Participants | 20 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 35 / 51 | 24 / 35 | 0 / 51 | 2 / 35 |
| serious Total, serious adverse events | 7 / 51 | 8 / 35 | 12 / 51 | 11 / 35 |
Outcome results
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.
Time frame: Day of delivery/birth
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mothers GBS | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ib (N=40, 22, 40, 22) | 3.35 µg/mL |
| Mothers GBS | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ia | 5.39 µg/mL |
| Mothers GBS | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS III (N=40, 25, 40, 25) | 2.45 µg/mL |
| Mothers Placebo | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ia | 0.41 µg/mL |
| Mothers Placebo | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ib (N=40, 22, 40, 22) | 0.064 µg/mL |
| Mothers Placebo | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS III (N=40, 25, 40, 25) | 0.056 µg/mL |
| Infants GBS | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ia | 4.37 µg/mL |
| Infants GBS | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS III (N=40, 25, 40, 25) | 1.65 µg/mL |
| Infants GBS | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ib (N=40, 22, 40, 22) | 2.59 µg/mL |
| Infants Placebo | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ib (N=40, 22, 40, 22) | 0.092 µg/mL |
| Infants Placebo | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS Ia | 0.4 µg/mL |
| Infants Placebo | Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth | GBS III (N=40, 25, 40, 25) | 0.055 µg/mL |
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.
Time frame: Day of delivery/birth
Population: The analysis was done on the Immunogenicity PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mothers GBS | Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery | GBS Ia | 0.81 Ratio |
| Mothers GBS | Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery | GBS Ib (N=40, 22) | 0.77 Ratio |
| Mothers GBS | Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery | GBS III (N=40, 25) | 0.68 Ratio |
| Mothers Placebo | Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery | GBS Ia | 0.97 Ratio |
| Mothers Placebo | Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery | GBS Ib (N=40, 22) | 1.44 Ratio |
| Mothers Placebo | Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery | GBS III (N=40, 25) | 0.99 Ratio |
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.
Time frame: Day 31, day of delivery, day 91 post-delivery
Population: The analysis was done on the Immunogenicity PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ia (Delivery/day 1) | 16 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ib (day 91 post-delivery/day 1; N=44, 32) | 33 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ib (Day 31/day 1; N=48, 30) | 18 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS III (Day 31/day 1; N=49, 32) | 17 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ia (day 91 post-delivery/day 1; N= 44, 34) | 19 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS III (Delivery/day 1) | 20 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ib (Delivery/day 1; N=50, 34) | 23 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS III (day 91 post-delivery/day 1; N=44, 34) | 28 Ratio |
| Mothers GBS | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ia (Day 31/day 1; N=49, 32) | 15 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS III (day 91 post-delivery/day 1; N=44, 34) | 1.11 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ia (Day 31/day 1; N=49, 32) | 1.22 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ia (Delivery/day 1) | 1.2 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ia (day 91 post-delivery/day 1; N= 44, 34) | 1.51 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ib (Day 31/day 1; N=48, 30) | 1.14 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ib (Delivery/day 1; N=50, 34) | 1.13 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS Ib (day 91 post-delivery/day 1; N=44, 32) | 1.53 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS III (Day 31/day 1; N=49, 32) | 1.19 Ratio |
| Mothers Placebo | Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects | GBS III (Delivery/day 1) | 1.08 Ratio |
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.
Time frame: Day of birth and day 91 after birth
Population: The analysis was done on the Immunogenicity PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mothers GBS | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ia (day of birth) | 5.14 μg/mL |
| Mothers GBS | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ia (day 91 after birth) | 1.28 μg/mL |
| Mothers GBS | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ib (day of birth; N=31, 20) | 2.93 μg/mL |
| Mothers GBS | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ib (day 91 after birth) | 0.54 μg/mL |
| Mothers GBS | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS III (day of birth; N=30, 22) | 1.93 μg/mL |
| Mothers GBS | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS III (day 91 after birth) | 0.43 μg/mL |
| Mothers Placebo | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS III (day of birth; N=30, 22) | 0.065 μg/mL |
| Mothers Placebo | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ia (day of birth) | 0.33 μg/mL |
| Mothers Placebo | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ib (day 91 after birth) | 0.063 μg/mL |
| Mothers Placebo | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ia (day 91 after birth) | 0.25 μg/mL |
| Mothers Placebo | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS III (day 91 after birth) | 0.065 μg/mL |
| Mothers Placebo | GMC (ELISA) of Anti-GBS CPS Antibodies in Infants | GBS Ib (day of birth; N=31, 20) | 0.1 μg/mL |
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.
Time frame: Day 1, day 31 and day 91 post-delivery
Population: The analysis was done on the Immunogenicity PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ia (day 31; N=49, 32) | 4.83 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ib (day 91 post-delivery; N= 44, 33) | 3.46 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ib (day 1; N= 50, 34) | 0.13 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS III (day 1) | 0.11 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ia (day 91 post-delivery; N = 44, 34) | 5.89 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS III (day 31; N= 49, 32) | 1.46 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ib (day 31; N=49, 31) | 1.68 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS III (day 91 post-delivery; N=44, 34) | 2.69 µg/mL |
| Mothers GBS | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ia (day 1) | 0.28 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS III (day 91 post-delivery; N=44, 34) | 0.11 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ia (day 1) | 0.37 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ia (day 31; N=49, 32) | 0.36 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ia (day 91 post-delivery; N = 44, 34) | 0.46 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ib (day 1; N= 50, 34) | 0.084 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ib (day 31; N=49, 31) | 0.14 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS Ib (day 91 post-delivery; N= 44, 33) | 0.17 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS III (day 1) | 0.093 µg/mL |
| Mothers Placebo | GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects | GBS III (day 31; N= 49, 32) | 0.12 µg/mL |
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.
Time frame: Day 91 after birth
Population: The analysis was done on the Immunogenicity PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mothers GBS | GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth | GBS Ia | 0.25 Ratio |
| Mothers GBS | GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth | GBS Ib (N=31, 20 ) | 0.22 Ratio |
| Mothers GBS | GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth | GBS III (N=30, 22) | 0.25 Ratio |
| Mothers Placebo | GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth | GBS Ia | 0.76 Ratio |
| Mothers Placebo | GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth | GBS Ib (N=31, 20 ) | 0.54 Ratio |
| Mothers Placebo | GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth | GBS III (N=30, 22) | 0.85 Ratio |
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.
Time frame: From day 1 to 7 after vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Pain (N =49, 34) | 35 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Induration (>=25 mm; N =49, 34) | 6 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Swelling (>=25 mm; N =49, 34) | 4 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis (>=25 mm; N =49, 34 ) | 2 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Erythema (>=25 mm; N =49, 34) | 6 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any systemic | 46 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Chills (N =49, 34) | 4 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fatigue (N =49, 34) | 31 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Malaise (N =49, 34) | 14 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Myalgia (N =49, 34) | 27 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Headache (N =49, 34) | 16 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Rash (N =49, 34) | 2 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Arthralgia (N =49, 34) | 4 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Nausea (N =49, 34) | 6 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fever, body temperature >38° C (N =49, 33) | 0 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any other | 8 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Stayed home (N =49, 34) | 2 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Use of analgesics/antipyretics (N =49, 34) | 6 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any local | 40 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Use of analgesics/antipyretics (N =49, 34) | 3 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Headache (N =49, 34) | 21 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Induration (>=25 mm; N =49, 34) | 0 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any other | 3 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Swelling (>=25 mm; N =49, 34) | 0 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Rash (N =49, 34) | 3 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Ecchymosis (>=25 mm; N =49, 34 ) | 0 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any local | 24 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Pain (N =49, 34) | 12 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Arthralgia (N =49, 34) | 9 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Any systemic | 38 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Stayed home (N =49, 34) | 0 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Chills (N =49, 34) | 3 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Nausea (N =49, 34) | 9 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fatigue (N =49, 34) | 26 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Erythema (>=25 mm; N =49, 34) | 0 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Malaise (N =49, 34) | 9 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Fever, body temperature >38° C (N =49, 33) | 0 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | Myalgia (N =49, 34) | 3 Percentages of subjects |
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.
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.
Population: The analysis was done on the Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mothers GBS | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | Any SAE | 14 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | AEs leading to withdrawal | 0 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | Medically-attended AEs | 51 Percentages of subjects |
| Mothers GBS | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | Any unsolicited AE | 63 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | AEs leading to withdrawal | 0 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | Any unsolicited AE | 74 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | Medically-attended AEs | 54 Percentages of subjects |
| Mothers Placebo | Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) | Any SAE | 23 Percentages of subjects |
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.
Time frame: From birth until study termination
Population: The analysis was done on the Safety Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mothers GBS | Percentages of Infants Reporting SAEs | 24 Percentages of subjects |
| Mothers Placebo | Percentages of Infants Reporting SAEs | 31 Percentages of subjects |
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.
Time frame: 1 month after the last routine infant immunization
Population: The analysis was done on the Immunogenicity PPS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mothers GBS | 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 Percentages of subjects |
| Mothers 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 Percentages of subjects |