Streptococcal Infections
Conditions
Keywords
Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection
Brief summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
Interventions
BIOLOGICALGroup B Streptococcus Trivalent Vaccine - 20/20/20 μg
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
OTHERSaline solution
Subjects received two injection of saline solution.
BIOLOGICALGroup B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
BIOLOGICALGroup B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
BIOLOGICALGroup B Streptococcus Trivalent Vaccine - 5/5/5 μg
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
OTHERsaline solution
Subjects received one injection of saline solution.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive. * Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)
Exclusion criteria
* Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive * Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Day 61, one month after the second vaccination | The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL. |
| Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. | Day 61, one month after the second vaccination | Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart . |
| The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Day of delivery | The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL. |
| Antibody GMC in Maternal Subjects at Day of Delivery | Day of delivery | Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events | Day 61 | Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported. |
| Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | From day 1 to one year after delivery | Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo. |
| The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | Day 31, one month after vaccination | The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL. |
| Number of Infants Reporting Serious Adverse Events | one year after birth | Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events |
| Antibody GMC Per Serotype at Different Time Points in Infants | Day 4, day 43 and day 91 after birth | Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo. |
| Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | day 31 | Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo. |
| The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Day 361, one year after the first vaccination | The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL. |
| Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination | Day 361, one year after the first vaccination | Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | 40 |
| Non-pregnant/Placebo Non-pregnant women received two injections of saline solution | 20 |
| Pregnant 0.5/0.5/0.5 μg Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | 80 |
| Pregnant 2.5/2.5/2.5 μg Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | 80 |
| Pregnant 5/5/5 μg Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | 80 |
| Pregnant/Placebo Pregnant women who received one injection of saline solution | 80 |
| Infants 0.5/0.5/0.5 μg Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | 80 |
| Infants 2.5/2.5/2.5 μg Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | 80 |
| Infants 5/5/5 μg Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | 76 |
| Infants / Placebo Infants born from women who received one injection of saline solution | 81 |
| Total | 697 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 3 | 2 | 4 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 1 | 3 | 3 | 1 | 0 | 2 | 3 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Unable to classify | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 5 | 1 | 3 | 1 | 3 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Maternal subjects | NA years | NA years | 25.3 years STANDARD_DEVIATION 5.2 | 25.3 years STANDARD_DEVIATION 5.2 | 24.2 years STANDARD_DEVIATION 4.7 | 25.7 years STANDARD_DEVIATION 5.4 | NA years | NA years | NA years | NA years | 25.1 years STANDARD_DEVIATION 5.1 |
| Age, Customized Non pregnant subjects | 28.6 years STANDARD_DEVIATION 5 | 29.4 years STANDARD_DEVIATION 5.1 | NA years | NA years | NA years | NA years | NA years | NA years | NA years | NA years | 28.8 years STANDARD_DEVIATION 5 |
| Age, Customized | NA days | NA days | NA days | NA days | NA days | NA days | 3.0 days STANDARD_DEVIATION 3.3 | 4.0 days STANDARD_DEVIATION 7.8 | 5.5 days STANDARD_DEVIATION 16.9 | 3.5 days STANDARD_DEVIATION 8.8 | 4.0 days STANDARD_DEVIATION 10.3 |
| Region of Enrollment South Africa | 40 participants | 20 participants | 80 participants | 80 participants | 80 participants | 80 participants | 80 participants | 80 participants | 76 participants | 81 participants | 697 participants |
| Sex: Female, Male Female | 40 Participants | 20 Participants | 80 Participants | 80 Participants | 80 Participants | 80 Participants | 45 Participants | 38 Participants | 33 Participants | 48 Participants | 544 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 35 Participants | 42 Participants | 43 Participants | 33 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 40 / 40 | 19 / 20 | 72 / 80 | 67 / 80 | 70 / 80 | 71 / 80 | 44 / 79 | 49 / 79 | 48 / 74 | 51 / 78 |
| serious Total, serious adverse events | 2 / 40 | 1 / 20 | 27 / 80 | 24 / 80 | 25 / 80 | 30 / 80 | 19 / 79 | 13 / 79 | 13 / 74 | 18 / 78 |
Outcome results
Primary
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
Time frame: Day 61, one month after the second vaccination
Population: FAS - primary, non-pregnant subjects
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. | Serotype Ia (N=34, 19) | 40 concentrations (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. | Serotype Ib (N=33, 17) | 5.3 concentrations (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. | Serotype III | 11 concentrations (μg/mL) |
| Non-pregnant/Placebo | Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. | Serotype Ia (N=34, 19) | 0.88 concentrations (μg/mL) |
| Non-pregnant/Placebo | Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. | Serotype Ib (N=33, 17) | 0.25 concentrations (μg/mL) |
| Non-pregnant/Placebo | Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. | Serotype III | 0.61 concentrations (μg/mL) |
Primary
Antibody GMC in Maternal Subjects at Day of Delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
Time frame: Day of delivery
Population: FAS primary, maternal subjects
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ia (N= 76, 77, 73, 76) | 9.95 Concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype III (N=74, 77, 73, 78) | 2.63 Concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ib (N=69, 74, 71, 58) | 2.5 Concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ia (N= 76, 77, 73, 76) | 14 Concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype III (N=74, 77, 73, 78) | 3.66 Concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ib (N=69, 74, 71, 58) | 4.3 Concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ib (N=69, 74, 71, 58) | 2.93 Concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ia (N= 76, 77, 73, 76) | 24 Concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype III (N=74, 77, 73, 78) | 2.83 Concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ia (N= 76, 77, 73, 76) | 0.67 Concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype III (N=74, 77, 73, 78) | 0.25 Concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC in Maternal Subjects at Day of Delivery | Serotype Ib (N=69, 74, 71, 58) | 0.38 Concentration (μg/mL) |
Primary
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time frame: Day of delivery
Population: FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 1 μg/mL (N=76,77, 73, 76) | 86 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78) | 62 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58) | 41 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76) | 75 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58) | 36 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78) | 69 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76) | 72 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76) | 78 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78) | 39 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76) | 64 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58) | 58 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78) | 49 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 2 μg/mL (69, 74, 71, 58) | 52 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78) | 34 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58) | 43 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58) | 49 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78) | 53 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76) | 64 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58) | 41 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76) | 74 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78) | 66 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78) | 44 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58) | 36 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76) | 71 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 2 μg/mL (69, 74, 71, 58) | 51 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78) | 35 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78) | 49 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58) | 65 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76) | 69 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 1 μg/mL (N=76,77, 73, 76) | 83 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58) | 42 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 1 μg/mL (N=76,77, 73, 76) | 89 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76) | 81 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76) | 77 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76) | 75 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76) | 71 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58) | 65 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 2 μg/mL (69, 74, 71, 58) | 48 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58) | 37 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58) | 32 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78) | 64 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78) | 51 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78) | 42 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78) | 36 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78) | 29 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 2 μg/mL (69, 74, 71, 58) | 10 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76) | 26 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78) | 9 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58) | 14 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76) | 9 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 1 μg/mL (N=76,77, 73, 76) | 38 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78) | 4 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76) | 18 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76) | 21 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78) | 3 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58) | 3 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58) | 9 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78) | 3 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78) | 14 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. | Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58) | 10 percentage of subjects |
Primary
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time frame: Day 61, one month after the second vaccination
Population: Full Analysis Set (FAS) - primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=1 μg/mL (N=33, 17) | 73 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=2 μg/mL (N=34, 19) | 91 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=3 μg/mL | 63 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=3 μg/mL (N=34, 19) | 88 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=1 μg/mL | 89 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=5 μg/mL (N=34, 19) | 79 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=5 μg/mL | 51 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=8 μg/mL (N=34, 19) | 76 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=8 μg/mL (N=33, 17) | 39 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=2 μg/mL (N=33, 17) | 67 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=8 μg/mL | 49 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=3 μg/mL (N=33, 17) | 64 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=2 μg/mL | 69 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=5 μg/mL (N=33, 17) | 42 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=1 μg/mL (N=34, 19) | 91 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=5 μg/mL (N=33, 17) | 6 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=8 μg/mL (N=33, 17) | 6 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=1 μg/mL | 37 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=2 μg/mL | 21 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=3 μg/mL | 21 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=5 μg/mL | 11 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype III >=8 μg/mL | 5 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=1 μg/mL (N=34, 19) | 37 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=2 μg/mL (N=34, 19) | 32 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=3 μg/mL (N=34, 19) | 26 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=5 μg/mL (N=34, 19) | 16 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=1 μg/mL (N=33, 17) | 24 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=2 μg/mL (N=33, 17) | 12 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ib >=3 μg/mL (N=33, 17) | 6 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. | Serotype Ia >=8 μg/mL (N=34, 19) | 16 percentage of subjects |
Secondary
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
Time frame: Day 361, one year after the first vaccination
Population: FAS persistence, non-pregnant subjects
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination | serotype Ia | 15 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination | serotype Ib (N=37, 19) | 5.28 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination | serotype III | 7.03 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination | serotype Ia | 0.86 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination | serotype Ib (N=37, 19) | 0.4 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination | serotype III | 0.3 concentration (μg/mL) |
Secondary
Antibody GMC Per Serotype at Different Time Points in Infants
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Time frame: Day 4, day 43 and day 91 after birth
Population: Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 91; N= 63, 63, 57, 69) | 0.6 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 4; N=75, 76, 69, 73) | 6.66 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 43; N= 75, 76, 68, 71) | 3.21 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 91; N=71, 75, 64, 75) | 1.97 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 4; N=71, 71, 66, 62) | 1.15 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 43; N=72, 77, 67, 69) | 0.73 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 91; N= 74, 73, 66, 76) | 0.85 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 4; N= 57, 64, 58, 52) | 2.11 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 43; N= 64, 75, 61, 63) | 0.82 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 91; N= 63, 63, 57, 69) | 0.69 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 43; N=72, 77, 67, 69) | 0.88 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 43; N= 75, 76, 68, 71) | 2.95 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 91; N=71, 75, 64, 75) | 2.22 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 43; N= 64, 75, 61, 63) | 0.88 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 91; N= 74, 73, 66, 76) | 1.08 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 4; N=75, 76, 69, 73) | 6.52 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 4; N=71, 71, 66, 62) | 1.72 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 4; N= 57, 64, 58, 52) | 2.3 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 91; N= 63, 63, 57, 69) | 0.51 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 4; N= 57, 64, 58, 52) | 1.72 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 4; N=75, 76, 69, 73) | 12 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 4; N=71, 71, 66, 62) | 1.39 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 91; N=71, 75, 64, 75) | 2.78 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 43; N= 75, 76, 68, 71) | 5.54 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 43; N= 64, 75, 61, 63) | 0.68 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 43; N=72, 77, 67, 69) | 0.67 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 91; N= 74, 73, 66, 76) | 0.83 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 43; N= 64, 75, 61, 63) | 0.16 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 91; N= 63, 63, 57, 69) | 0.27 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 91; N=71, 75, 64, 75) | 0.38 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 4; N=71, 71, 66, 62) | 0.21 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 43; N=72, 77, 67, 69) | 0.15 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 43; N= 75, 76, 68, 71) | 0.31 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ib (day 91; N= 74, 73, 66, 76) | 0.5 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype Ia (day 4; N=75, 76, 69, 73) | 0.49 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype at Different Time Points in Infants | Serotype III (day 4; N= 57, 64, 58, 52) | 0.29 concentration (μg/mL) |
Secondary
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
Time frame: day 31
Population: FAS, secondary, maternal subjects, day 31
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ia (N=75, 74, 69, 75) | 13 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype III (N=73, 74, 68, 76) | 3.01 concentration (μg/mL) |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ib (N=65, 69, 66, 61) | 2.78 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ia (N=75, 74, 69, 75) | 15 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype III (N=73, 74, 68, 76) | 4.11 concentration (μg/mL) |
| Non-pregnant/Placebo | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ib (N=65, 69, 66, 61) | 5.42 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ib (N=65, 69, 66, 61) | 3.66 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ia (N=75, 74, 69, 75) | 26 concentration (μg/mL) |
| Pregnant 5/5/5 μg | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype III (N=73, 74, 68, 76) | 2.77 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ia (N=75, 74, 69, 75) | 0.62 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype III (N=73, 74, 68, 76) | 0.19 concentration (μg/mL) |
| Pregnant/Placebo | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination | serotype Ib (N=65, 69, 66, 61) | 0.3 concentration (μg/mL) |
Secondary
Number of Infants Reporting Serious Adverse Events
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
Time frame: one year after birth
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Infants Reporting Serious Adverse Events | Serious AEs | 19 Number of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Infants Reporting Serious Adverse Events | At least possibly related SAEs | 0 Number of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Infants Reporting Serious Adverse Events | AEs leading to withdrawal | 1 Number of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Infants Reporting Serious Adverse Events | AEs leading to death | 1 Number of subjects |
| Non-pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | At least possibly related SAEs | 0 Number of subjects |
| Non-pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | AEs leading to withdrawal | 2 Number of subjects |
| Non-pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | AEs leading to death | 2 Number of subjects |
| Non-pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | Serious AEs | 13 Number of subjects |
| Pregnant 5/5/5 μg | Number of Infants Reporting Serious Adverse Events | AEs leading to withdrawal | 0 Number of subjects |
| Pregnant 5/5/5 μg | Number of Infants Reporting Serious Adverse Events | At least possibly related SAEs | 0 Number of subjects |
| Pregnant 5/5/5 μg | Number of Infants Reporting Serious Adverse Events | AEs leading to death | 0 Number of subjects |
| Pregnant 5/5/5 μg | Number of Infants Reporting Serious Adverse Events | Serious AEs | 13 Number of subjects |
| Pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | AEs leading to death | 1 Number of subjects |
| Pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | At least possibly related SAEs | 0 Number of subjects |
| Pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | Serious AEs | 18 Number of subjects |
| Pregnant/Placebo | Number of Infants Reporting Serious Adverse Events | AEs leading to withdrawal | 1 Number of subjects |
Secondary
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
Time frame: From day 1 to one year after delivery
Population: Safety set, solicited and unsolicited reactogenicity, maternal subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | solicited adverse events (N=80, 80, 79, 80) | 59 participants |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | unsolicited adverse events | 70 participants |
| Non-pregnant/Placebo | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | solicited adverse events (N=80, 80, 79, 80) | 46 participants |
| Non-pregnant/Placebo | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | unsolicited adverse events | 59 participants |
| Pregnant 5/5/5 μg | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | solicited adverse events (N=80, 80, 79, 80) | 59 participants |
| Pregnant 5/5/5 μg | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | unsolicited adverse events | 62 participants |
| Pregnant/Placebo | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | unsolicited adverse events | 69 participants |
| Pregnant/Placebo | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events | solicited adverse events (N=80, 80, 79, 80) | 57 participants |
Secondary
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Time frame: Day 61
Population: Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events | Solicited adverse events | 40 participants |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events | Unsolicited adverse events | 30 participants |
| Non-pregnant/Placebo | Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events | Solicited adverse events | 19 participants |
| Non-pregnant/Placebo | Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events | Unsolicited adverse events | 16 participants |
Secondary
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
Time frame: Day 361, one year after the first vaccination
Population: FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=8μg/mL | 62 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=5μg/mL (N=37, 19) | 38 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=2μg/mL | 76 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=8μg/mL (N=37, 19) | 32 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=1μg/mL (N=37, 19) | 81 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=1μg/mL | 81 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=5μg/mL | 70 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=2μg/mL | 70 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=2μg/mL (N=37, 19) | 65 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=3μg/mL | 65 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=3μg/mL | 76 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=5μg/mL | 54 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=3μg/mL (37, 19) | 62 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=8μg/mL | 41 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=1μg/mL | 86 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=8μg/mL | 5 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=1μg/mL | 30 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=2μg/mL | 30 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=3μg/mL | 25 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=5μg/mL | 15 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ia >=8μg/mL | 10 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=1μg/mL (N=37, 19) | 21 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=2μg/mL (N=37, 19) | 16 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=3μg/mL (37, 19) | 5 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=5μg/mL (N=37, 19) | 5 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype Ib >=8μg/mL (N=37, 19) | 5 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=1μg/mL | 20 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=2μg/mL | 15 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=3μg/mL | 15 percentage of subjects |
| Non-pregnant/Placebo | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. | Serotype III >=5μg/mL | 5 percentage of subjects |
Secondary
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time frame: Day 31, one month after vaccination
Population: FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=1μg/mL (N=75, 74, 69, 75) | 85 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=2μg/mL (N=73, 74, 68, 76) | 58 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=5μg/mL (N= 65, 69, 66, 61) | 48 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=3μg/mL (N=75, 74, 69, 75) | 76 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=8μg/mL (N= 65, 69, 66, 61) | 43 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=1μg/mL (N= 73, 74, 68, 76) | 70 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=5μg/mL (N=75, 74, 69, 75) | 75 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=2μg/mL (N=75, 74, 69, 75) | 79 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=5μg/mL (N=73, 74, 68, 76) | 41 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=8μg/mL (N=75, 74, 69, 75) | 71 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=1μg/mL (N= 65, 69, 66, 61) | 65 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=3μg/mL (N=73, 74, 68, 76) | 48 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=2μg/mL (N= 65, 69, 66, 61) | 60 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=8μg/mL (N=73, 74, 68, 76) | 38 percentage of subjects |
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=3μg/mL (N= 65, 69, 66, 61) | 54 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=3μg/mL (N= 65, 69, 66, 61) | 48 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=2μg/mL (N=73, 74, 68, 76) | 54 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=8μg/mL (N=75, 74, 69, 75) | 70 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=5μg/mL (N= 65, 69, 66, 61) | 43 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=2μg/mL (N=75, 74, 69, 75) | 77 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=1μg/mL (N= 73, 74, 68, 76) | 65 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=3μg/mL (N=73, 74, 68, 76) | 50 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=8μg/mL (N= 65, 69, 66, 61) | 39 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=3μg/mL (N=75, 74, 69, 75) | 73 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=2μg/mL (N= 65, 69, 66, 61) | 54 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=8μg/mL (N=73, 74, 68, 76) | 34 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=5μg/mL (N=73, 74, 68, 76) | 43 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=1μg/mL (N= 65, 69, 66, 61) | 68 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=5μg/mL (N=75, 74, 69, 75) | 70 percentage of subjects |
| Non-pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=1μg/mL (N=75, 74, 69, 75) | 77 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=3μg/mL (N= 65, 69, 66, 61) | 44 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=1μg/mL (N=75, 74, 69, 75) | 88 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=2μg/mL (N=75, 74, 69, 75) | 81 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=3μg/mL (N=75, 74, 69, 75) | 78 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=5μg/mL (N=75, 74, 69, 75) | 71 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=8μg/mL (N=75, 74, 69, 75) | 71 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=1μg/mL (N= 65, 69, 66, 61) | 62 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=2μg/mL (N= 65, 69, 66, 61) | 50 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=5μg/mL (N= 65, 69, 66, 61) | 36 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=8μg/mL (N= 65, 69, 66, 61) | 30 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=1μg/mL (N= 73, 74, 68, 76) | 57 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=2μg/mL (N=73, 74, 68, 76) | 51 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=3μg/mL (N=73, 74, 68, 76) | 44 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=5μg/mL (N=73, 74, 68, 76) | 32 percentage of subjects |
| Pregnant 5/5/5 μg | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=8μg/mL (N=73, 74, 68, 76) | 29 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=2μg/mL (N= 65, 69, 66, 61) | 13 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=2μg/mL (N=75, 74, 69, 75) | 27 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=2μg/mL (N=73, 74, 68, 76) | 12 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=1μg/mL (N= 65, 69, 66, 61) | 21 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=8μg/mL (N=75, 74, 69, 75) | 9 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=1μg/mL (N=75, 74, 69, 75) | 33 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=3μg/mL (N=73, 74, 68, 76) | 4 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=5μg/mL (N=75, 74, 69, 75) | 15 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ia>=3μg/mL (N=75, 74, 69, 75) | 23 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=8μg/mL (N=73, 74, 68, 76) | 3 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=8μg/mL (N= 65, 69, 66, 61) | 8 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=5μg/mL (N= 65, 69, 66, 61) | 10 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=5μg/mL (N=73, 74, 68, 76) | 3 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype III>=1μg/mL (N= 73, 74, 68, 76) | 13 percentage of subjects |
| Pregnant/Placebo | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. | serotype Ib>=3μg/mL (N= 65, 69, 66, 61) | 11 percentage of subjects |