Group B Streptococcal Infection
Conditions
Brief summary
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 30 participants will receive three doses of placebo (saline).
Detailed description
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; Group 1 will receive one injection of placebo at 22 (±1) weeks gestational age (GA), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA. Group 2 will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA.Group 3 will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA. Group 4 will receive one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA. Group 5 will receive an injection of placebo at 22, 26 and 30 weeks (±1) GA. Participants will attend the clinic for assessment visits up to delivery and for a further 3 visits at 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery. Babies will be also be assessed at delivery, and 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery.
Interventions
BIOLOGICALGBS-NN/NN2 Vaccine
0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.
BIOLOGICALPlacebo
0.5 mL normal saline given by intramuscular injection
Sponsors
Larix A/S
Minervax ApS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to one of 5 groups
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
1. Healthy pregnant woman above the legally defined age of consent at the time of screening 2. Carrying a normal singleton pregnancy, and is at 21+0 to 23+6 weeks GA at the planned tme of the 1st vaccination, as established by first/second trimester ultrasound examination 3. Properly informed about the study and has given written informed consent and parental consent (for her baby) in accordance with the International Conference on Harmonization Good Clinical Practice (ICH GCP) and local legislation prior to the first study intervention 4. Grants access to her own and her baby's study related medical records
Exclusion criteria
1. Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine 2. BMI of \<17 or \>40 at the time of screening 3. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) positive or positive for syphilis 4. Knowingly carrying, at screening, a malformed or genetically abnormal foetus, incl. renal pelvis dilation, single umbilical artery (screening will be undertaken after the ultrasound conducted for the detection of anomalies) 5. Chronic or pregnancy induced hypertension at screening, \>1+ protein in urine regardless of blood pressure or 1+ protein in urine and hypertension 6. Experienced a previous stillbirth prior to going into labour 7. Gestational, type 1 or type 2 diabetes 8. Potential placenta previa as per malformation ultrasound scan 9. Rhesus negative and has anti-D antibodies or other potential harmful antibodies 10. Known or suspected allergies to any components of the vaccine including to aluminium or aminoglycoside antibiotics, or an allergic reaction related to a previous vaccination 11. Fever (temperature \>37.9°C) on the day of receiving the first dose or an acute infection in the 7 days before the first dose (the first dose can be delayed if gestational age permits) 12. Received systemic steroids in the 6 weeks before the first dose (inhaled and topical steroids are acceptable) 13. Any lesion (including tattoos) at the planned injection site that will impair the assessment of the injection site 14. Received immunosuppressive medication, chemotherapy or radiotherapy in the 24 weeks before the first dose 15. Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before the first dose 16. Anaemia, haemoglobin (\<10 g/dL, 100 g/L, 6.2 mmol/L) 17. Currently breast feeding 18. Received any investigational medicinal product or vaccine in the 12 weeks or 5 half-lives before the first dose 19. Received an approved vaccine within the 4 weeks before the first dose or expects to receive an approved vaccine during the study. Routine vaccinations recommended during pregnancy (e.g., pertussis and influenza) are permitted but every effort should be made to separate routine vaccinations from the trial vaccinations by at least 7 days. 20. Known or suspected immunodeficiency or cancer (leukaemia, lymphoma), or a family history of congenital or hereditary immunodeficiency 21. History or presence of uncontrolled cardiovascular disease, pulmonary, hepatic, gall bladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, or autoimmune disease 22. History of, or current drug or alcohol abuse 23. In the opinion of the investigator not suitable for inclusion in the study 24. The pregnancy is considered high risk by treating physicians
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Delivery | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Following the Vaccinations in the Mother | To Day 84 | Number of participants with solicited and other adverse events following the vaccinations |
| Clinically Significant Abnormal Laboratory Tests in the Mother | To Day 84 | Number of participants with clinically significant abnormal laboratory tests in the mother |
| Clinically Significant Changes in Vital Signs in the Mother | To Day 84 | Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother |
| Clinically Significant Changes in Physical Examination in the Mother | To Day 84 | Number of participants with clinically significant changes in physical examination in the mother |
| Gestational Age | Delivery | Gestational age at birth |
| Injection Site Reactions in the Mother | 7 days following each injection | Number of participants with solicited injection site reactions following vaccination |
| Length of the Baby | Delivery | Length of the baby |
| Head Circumference of the Baby | Delivery | Head circumference of the baby |
| Apgar Score in the Baby | 1, 5 and 10 minutes | Apgar score in the baby (Appearance; Pulse; Grimace response; Activity; Respiration). Range 0 to 10 where high scores are good and low scores are bad. |
| Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Delivery | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood |
| Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | 1 month, 3 months | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby |
| Weight of the Baby | Delivery | Weight of the baby |
Countries
Denmark, South Africa, United Kingdom
Participant flow
Recruitment details
The first participant first visit took place on 17 February 2022 and the last participant last visit took place on 18 October 2023.
Pre-assignment details
A total of 269 maternal participants were enrolled in the study and randomised to one of the 5 study groups.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA
GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.
Placebo: 0.5 mL normal saline given by intramuscular injection | 61 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA
GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.
Placebo: 0.5 mL normal saline given by intramuscular injection | 59 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA
GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.
Placebo: 0.5 mL normal saline given by intramuscular injection | 59 |
| Group 4: Single Dose Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA.
GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.
Placebo: 0.5 mL normal saline given by intramuscular injection | 60 |
| Group 5: Placebo Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA
Placebo: 0.5 mL normal saline given by intramuscular injection | 30 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Baby loss | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 3 | 0 |
| Overall Study | Relocated to another province | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 2 | 4 | 0 |
Baseline characteristics
| Characteristic | Group 1: 4 Week Dose Interval; 2 Doses | Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses | Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses | Group 4: Single Dose | Group 5: Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 59 Participants | 59 Participants | 60 Participants | 30 Participants | 269 Participants |
| Age, Continuous | 28.9 years STANDARD_DEVIATION 5.26 | 27.5 years STANDARD_DEVIATION 4.81 | 27.8 years STANDARD_DEVIATION 5.34 | 27.3 years STANDARD_DEVIATION 5.37 | 28.3 years STANDARD_DEVIATION 6.65 | 27.9 years STANDARD_DEVIATION 5.37 |
| BMI | 27.2 kg/m² STANDARD_DEVIATION 5.28 | 27.9 kg/m² STANDARD_DEVIATION 5.32 | 27.6 kg/m² STANDARD_DEVIATION 5.35 | 27.5 kg/m² STANDARD_DEVIATION 5.57 | 28.8 kg/m² STANDARD_DEVIATION 5.38 | 27.7 kg/m² STANDARD_DEVIATION 5.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 59 Participants | 58 Participants | 60 Participants | 29 Participants | 265 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 161.7 cm STANDARD_DEVIATION 7.84 | 162.2 cm STANDARD_DEVIATION 8 | 163.3 cm STANDARD_DEVIATION 7.58 | 160.5 cm STANDARD_DEVIATION 6.88 | 160.5 cm STANDARD_DEVIATION 6.92 | 161.8 cm STANDARD_DEVIATION 7.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 41 Participants | 43 Participants | 44 Participants | 22 Participants | 194 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 18 Participants | 16 Participants | 14 Participants | 8 Participants | 72 Participants |
| Region of Enrollment Denmark | 13 participants | 14 participants | 12 participants | 13 participants | 7 participants | 59 participants |
| Region of Enrollment South Africa | 44 participants | 42 participants | 43 participants | 44 participants | 22 participants | 195 participants |
| Region of Enrollment United Kingdom | 4 participants | 3 participants | 4 participants | 3 participants | 1 participants | 15 participants |
| Sex: Female, Male Female | 61 Participants | 59 Participants | 59 Participants | 60 Participants | 30 Participants | 269 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 71.1 kg STANDARD_DEVIATION 14 | 73.0 kg STANDARD_DEVIATION 12.11 | 73.6 kg STANDARD_DEVIATION 14.52 | 70.6 kg STANDARD_DEVIATION 14.59 | 74.2 kg STANDARD_DEVIATION 13.38 | 72.3 kg STANDARD_DEVIATION 13.76 |
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 | 0 / 61 | 0 / 59 | 0 / 59 | 0 / 60 | 0 / 30 | 2 / 61 | 2 / 58 | 1 / 58 | 3 / 57 | 1 / 29 |
| other Total, other adverse events | 56 / 61 | 54 / 59 | 57 / 59 | 56 / 60 | 26 / 30 | 43 / 61 | 38 / 58 | 38 / 58 | 45 / 57 | 21 / 29 |
| serious Total, serious adverse events | 23 / 61 | 12 / 59 | 20 / 59 | 25 / 60 | 14 / 30 | 15 / 61 | 13 / 58 | 16 / 58 | 17 / 57 | 7 / 29 |
Outcome results
Primary
Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby
Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth.
Time frame: Delivery
Population: Baby Immunogenicicty Set : babies with at least one evaluable sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp1N | 11.12 μg/mL | Geometric Coefficient of Variation 236.7 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp2N | 7.93 μg/mL | Geometric Coefficient of Variation 164 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | AlpCN | 8.85 μg/mL | Geometric Coefficient of Variation 246.7 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | RibN | 3.67 μg/mL | Geometric Coefficient of Variation 157.6 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp1N | 5.52 μg/mL | Geometric Coefficient of Variation 183.9 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | RibN | 1.76 μg/mL | Geometric Coefficient of Variation 434.2 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp2N | 5.32 μg/mL | Geometric Coefficient of Variation 280.9 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | AlpCN | 6.71 μg/mL | Geometric Coefficient of Variation 337.4 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | RibN | 3.23 μg/mL | Geometric Coefficient of Variation 283.3 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp2N | 5.46 μg/mL | Geometric Coefficient of Variation 445.7 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | AlpCN | 7.39 μg/mL | Geometric Coefficient of Variation 374.6 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp1N | 7.95 μg/mL | Geometric Coefficient of Variation 261.6 |
| Group 4: Single Dose (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp1N | 3.51 μg/mL | Geometric Coefficient of Variation 565.2 |
| Group 4: Single Dose (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp2N | 3.39 μg/mL | Geometric Coefficient of Variation 717.6 |
| Group 4: Single Dose (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | RibN | 1.28 μg/mL | Geometric Coefficient of Variation 520.6 |
| Group 4: Single Dose (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | AlpCN | 3.10 μg/mL | Geometric Coefficient of Variation 682 |
| Group 5: Placebo (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | RibN | 0.06 μg/mL | Geometric Coefficient of Variation 129.4 |
| Group 5: Placebo (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | AlpCN | 0.06 μg/mL | Geometric Coefficient of Variation 137.5 |
| Group 5: Placebo (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp2N | 0.04 μg/mL | Geometric Coefficient of Variation 112.9 |
| Group 5: Placebo (Infant Participants) | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Alp1N | 0.07 μg/mL | Geometric Coefficient of Variation 102.2 |
Secondary
Adverse Events Following the Vaccinations in the Mother
Number of participants with solicited and other adverse events following the vaccinations
Time frame: To Day 84
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Adverse Events Following the Vaccinations in the Mother | 56 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Adverse Events Following the Vaccinations in the Mother | 54 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Adverse Events Following the Vaccinations in the Mother | 57 participants |
| Group 4: Single Dose (Infant Participants) | Adverse Events Following the Vaccinations in the Mother | 56 participants |
| Group 5: Placebo (Infant Participants) | Adverse Events Following the Vaccinations in the Mother | 26 participants |
Secondary
Apgar Score in the Baby
Apgar score in the baby (Appearance; Pulse; Grimace response; Activity; Respiration). Range 0 to 10 where high scores are good and low scores are bad.
Time frame: 1, 5 and 10 minutes
Population: Baby safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 10 minutes | 9.9 score on a scale | Standard Deviation 0.29 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 5 minutes | 9.7 score on a scale | Standard Deviation 1.34 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 1 minute | 8.8 score on a scale | Standard Deviation 1.39 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 5 minutes | 9.8 score on a scale | Standard Deviation 0.54 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 1 minute | 9.0 score on a scale | Standard Deviation 0.91 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 10 minutes | 9.9 score on a scale | Standard Deviation 0.28 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 10 minutes | 9.9 score on a scale | Standard Deviation 0.33 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 1 minute | 8.8 score on a scale | Standard Deviation 1 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Apgar Score in the Baby | APGAR score at 5 minutes | 9.8 score on a scale | Standard Deviation 0.6 |
| Group 4: Single Dose (Infant Participants) | Apgar Score in the Baby | APGAR score at 10 minutes | 9.9 score on a scale | Standard Deviation 0.29 |
| Group 4: Single Dose (Infant Participants) | Apgar Score in the Baby | APGAR score at 1 minute | 8.9 score on a scale | Standard Deviation 1.38 |
| Group 4: Single Dose (Infant Participants) | Apgar Score in the Baby | APGAR score at 5 minutes | 9.9 score on a scale | Standard Deviation 0.32 |
| Group 5: Placebo (Infant Participants) | Apgar Score in the Baby | APGAR score at 1 minute | 8.8 score on a scale | Standard Deviation 1.22 |
| Group 5: Placebo (Infant Participants) | Apgar Score in the Baby | APGAR score at 5 minutes | 9.8 score on a scale | Standard Deviation 0.62 |
| Group 5: Placebo (Infant Participants) | Apgar Score in the Baby | APGAR score at 10 minutes | 10.0 score on a scale | Standard Deviation 0 |
Secondary
Clinically Significant Abnormal Laboratory Tests in the Mother
Number of participants with clinically significant abnormal laboratory tests in the mother
Time frame: To Day 84
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Abnormal Laboratory Tests in the Mother | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Abnormal Laboratory Tests in the Mother | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Abnormal Laboratory Tests in the Mother | 0 participants |
| Group 4: Single Dose (Infant Participants) | Clinically Significant Abnormal Laboratory Tests in the Mother | 0 participants |
| Group 5: Placebo (Infant Participants) | Clinically Significant Abnormal Laboratory Tests in the Mother | 0 participants |
Secondary
Clinically Significant Changes in Physical Examination in the Mother
Number of participants with clinically significant changes in physical examination in the mother
Time frame: To Day 84
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Changes in Physical Examination in the Mother | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Changes in Physical Examination in the Mother | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Changes in Physical Examination in the Mother | 0 participants |
| Group 4: Single Dose (Infant Participants) | Clinically Significant Changes in Physical Examination in the Mother | 0 participants |
| Group 5: Placebo (Infant Participants) | Clinically Significant Changes in Physical Examination in the Mother | 0 participants |
Secondary
Clinically Significant Changes in Vital Signs in the Mother
Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother
Time frame: To Day 84
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Changes in Vital Signs in the Mother | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Changes in Vital Signs in the Mother | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Clinically Significant Changes in Vital Signs in the Mother | 0 participants |
| Group 4: Single Dose (Infant Participants) | Clinically Significant Changes in Vital Signs in the Mother | 0 participants |
| Group 5: Placebo (Infant Participants) | Clinically Significant Changes in Vital Signs in the Mother | 0 participants |
Secondary
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby
Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby
Time frame: 1 month, 3 months
Population: Baby Immunogenicicty Set : babies with at least one evaluable sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 1 month of age | 4.81 μg/mL | Geometric Coefficient of Variation 419.4 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 3 months of age | 1.91 μg/mL | Geometric Coefficient of Variation 270.3 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 1 month of age | 4.25 μg/mL | Geometric Coefficient of Variation 379.8 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 3 months of age | 1.73 μg/mL | Geometric Coefficient of Variation 239.6 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 1 month of age | 4.90 μg/mL | Geometric Coefficient of Variation 495.8 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 3 months of age | 1.92 μg/mL | Geometric Coefficient of Variation 289.2 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 1 month of age | 2.46 μg/mL | Geometric Coefficient of Variation 190.5 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 3 months of age | 0.88 μg/mL | Geometric Coefficient of Variation 190.2 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 1 month of age | 2.87 μg/mL | Geometric Coefficient of Variation 281.3 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 3 months of age | 1.15 μg/mL | Geometric Coefficient of Variation 323.8 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 1 month of age | 2.92 μg/mL | Geometric Coefficient of Variation 184.7 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 3 months of age | 1.05 μg/mL | Geometric Coefficient of Variation 256.2 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 3 months of age | 1.24 μg/mL | Geometric Coefficient of Variation 149 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 3 months of age | 0.45 μg/mL | Geometric Coefficient of Variation 219.1 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 1 month of age | 3.44 μg/mL | Geometric Coefficient of Variation 264.8 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 1 month of age | 1.13 μg/mL | Geometric Coefficient of Variation 223.6 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 1 month of age | 2.13 μg/mL | Geometric Coefficient of Variation 264.1 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 3 months of age | 0.78 μg/mL | Geometric Coefficient of Variation 271.9 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 3 months of age | 1.37 μg/mL | Geometric Coefficient of Variation 247.2 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 3 months of age | 1.67 μg/mL | Geometric Coefficient of Variation 214.1 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 1 month of age | 3.91 μg/mL | Geometric Coefficient of Variation 283.4 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 3 months of age | 2.26 μg/mL | Geometric Coefficient of Variation 152.6 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 1 month of age | 7.02 μg/mL | Geometric Coefficient of Variation 116.3 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 1 month of age | 4.64 μg/mL | Geometric Coefficient of Variation 399 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 3 months of age | 0.54 μg/mL | Geometric Coefficient of Variation 515.7 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 1 month of age | 1.43 μg/mL | Geometric Coefficient of Variation 916.8 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 3 months of age | 0.59 μg/mL | Geometric Coefficient of Variation 427.3 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 1 month of age | 1.50 μg/mL | Geometric Coefficient of Variation 1065.8 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 3 months of age | 0.49 μg/mL | Geometric Coefficient of Variation 436 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 3 months of age | 0.22 μg/mL | Geometric Coefficient of Variation 465.2 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 1 month of age | 1.72 μg/mL | Geometric Coefficient of Variation 983.6 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 1 month of age | 0.77 μg/mL | Geometric Coefficient of Variation 560.9 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 3 months of age | 0.02 μg/mL | Geometric Coefficient of Variation 102 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 3 months of age | 0.03 μg/mL | Geometric Coefficient of Variation 92.1 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp2N: At 1 month of age | 0.05 μg/mL | Geometric Coefficient of Variation 534 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | RibN: At 1 month of age | 0.05 μg/mL | Geometric Coefficient of Variation 237.2 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 1 month of age | 0.05 μg/mL | Geometric Coefficient of Variation 424.7 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 3 months of age | 0.03 μg/mL | Geometric Coefficient of Variation 106.5 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Alp1N: At 3 months of age | 0.03 μg/mL | Geometric Coefficient of Variation 127.2 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | AlpCN: At 1 month of age | 0.07 μg/mL | Geometric Coefficient of Variation 384.9 |
Secondary
Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood
Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood
Time frame: Delivery
Population: Baby Immunogenicicty Set : babies with at least one evaluable sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp1N | 40.57 μg/mL | Geometric Coefficient of Variation 271 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp2N | 61.69 μg/mL | Geometric Coefficient of Variation 384.9 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | AlpCN | 48.11 μg/mL | Geometric Coefficient of Variation 314.7 |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | RibN | 25.55 μg/mL | Geometric Coefficient of Variation 323.2 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp1N | 15.81 μg/mL | Geometric Coefficient of Variation 295.1 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | RibN | 10.97 μg/mL | Geometric Coefficient of Variation 305.5 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp2N | 32.74 μg/mL | Geometric Coefficient of Variation 275.1 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | AlpCN | 25.17 μg/mL | Geometric Coefficient of Variation 328.6 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | RibN | 20.08 μg/mL | Geometric Coefficient of Variation 473.4 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp2N | 39.54 μg/mL | Geometric Coefficient of Variation 239.9 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | AlpCN | 27.53 μg/mL | Geometric Coefficient of Variation 332.7 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp1N | 32.91 μg/mL | Geometric Coefficient of Variation 322.2 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp1N | 12.38 μg/mL | Geometric Coefficient of Variation 604.4 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp2N | 18.96 μg/mL | Geometric Coefficient of Variation 491.4 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | RibN | 8.68 μg/mL | Geometric Coefficient of Variation 614.4 |
| Group 4: Single Dose (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | AlpCN | 16.38 μg/mL | Geometric Coefficient of Variation 482.6 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | RibN | 0.92 μg/mL | Geometric Coefficient of Variation 74.4 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | AlpCN | 1.10 μg/mL | Geometric Coefficient of Variation 86.4 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp2N | 1.02 μg/mL | Geometric Coefficient of Variation 95.9 |
| Group 5: Placebo (Infant Participants) | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Alp1N | 1.03 μg/mL | Geometric Coefficient of Variation 85.3 |
Secondary
Gestational Age
Gestational age at birth
Time frame: Delivery
Population: Baby safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Gestational Age | 38.7 weeks | Standard Deviation 2.88 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Gestational Age | 38.9 weeks | Standard Deviation 2.39 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Gestational Age | 38.9 weeks | Standard Deviation 2.3 |
| Group 4: Single Dose (Infant Participants) | Gestational Age | 38.8 weeks | Standard Deviation 2.37 |
| Group 5: Placebo (Infant Participants) | Gestational Age | 39.4 weeks | Standard Deviation 1.45 |
Secondary
Head Circumference of the Baby
Head circumference of the baby
Time frame: Delivery
Population: Baby safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Head Circumference of the Baby | 34.4 centimeters | Standard Deviation 1.83 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Head Circumference of the Baby | 34.3 centimeters | Standard Deviation 1.68 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Head Circumference of the Baby | 33.8 centimeters | Standard Deviation 2.49 |
| Group 4: Single Dose (Infant Participants) | Head Circumference of the Baby | 34.0 centimeters | Standard Deviation 2.19 |
| Group 5: Placebo (Infant Participants) | Head Circumference of the Baby | 34.8 centimeters | Standard Deviation 1.6 |
Secondary
Injection Site Reactions in the Mother
Number of participants with solicited injection site reactions following vaccination
Time frame: 7 days following each injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 2.5 - 5.0 cm | 0 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 0 - 2.4 cm | 5 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : >10 cm | 0 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Severe | 0 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : Palpable firmness only | 14 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Moderate | 3 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Mild | 35 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 2.5 - 5.0 cm | 2 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 0 - 2.4 cm | 7 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Itching | 23 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Severe | 0 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Moderate | 15 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 5.1 - 10.0 cm | 0 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Mild | 14 participants |
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 5.1 - 10.0 cm | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Severe | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 0 - 2.4 cm | 5 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 2.5 - 5.0 cm | 1 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 5.1 - 10.0 cm | 1 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : >10 cm | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : Palpable firmness only | 10 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 0 - 2.4 cm | 2 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 2.5 - 5.0 cm | 2 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 5.1 - 10.0 cm | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Moderate | 12 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Severe | 0 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Itching | 20 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Mild | 35 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Moderate | 3 participants |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Mild | 17 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 0 - 2.4 cm | 2 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Mild | 18 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : Palpable firmness only | 9 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Severe | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Severe | 1 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 5.1 - 10.0 cm | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Itching | 15 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 2.5 - 5.0 cm | 2 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : 0 - 2.4 cm | 9 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 5.1 - 10.0 cm | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 2.5 - 5.0 cm | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Redness : >10 cm | 0 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Moderate | 2 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Pain: Mild | 34 participants |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Moderate | 13 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Redness : 2.5 - 5.0 cm | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Redness : 5.1 - 10.0 cm | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 2.5 - 5.0 cm | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Pain: Severe | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 5.1 - 10.0 cm | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Moderate | 10 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 0 - 2.4 cm | 2 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Severe | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Itching | 14 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Pain: Mild | 24 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Redness : 0 - 2.4 cm | 5 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Mild | 16 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Redness : >10 cm | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Pain: Moderate | 0 participants |
| Group 4: Single Dose (Infant Participants) | Injection Site Reactions in the Mother | Swelling : Palpable firmness only | 6 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 2.5 - 5.0 cm | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Pain: Mild | 3 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 0 - 2.4 cm | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Swelling : Palpable firmness only | 1 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Redness : 2.5 - 5.0 cm | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Redness : 5.1 - 10.0 cm | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Redness : >10 cm | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Swelling : 5.1 - 10.0 cm | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Mild | 3 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Severe | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Pain: Moderate | 0 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Itching | 4 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Redness : 0 - 2.4 cm | 5 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Tenderness: Moderate | 1 participants |
| Group 5: Placebo (Infant Participants) | Injection Site Reactions in the Mother | Pain: Severe | 0 participants |
Secondary
Length of the Baby
Length of the baby
Time frame: Delivery
Population: Baby safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Length of the Baby | 50.3 centimeters | Standard Deviation 3.59 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Length of the Baby | 49.9 centimeters | Standard Deviation 2.96 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Length of the Baby | 49.3 centimeters | Standard Deviation 4.88 |
| Group 4: Single Dose (Infant Participants) | Length of the Baby | 48.9 centimeters | Standard Deviation 4.42 |
| Group 5: Placebo (Infant Participants) | Length of the Baby | 49.7 centimeters | Standard Deviation 4.45 |
Secondary
Weight of the Baby
Weight of the baby
Time frame: Delivery
Population: Baby safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: 4 Week Dose Interval; 2 Doses (Infant Participants) | Weight of the Baby | 3165.4 grams | Standard Deviation 585.45 |
| Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses (Infant Participants) | Weight of the Baby | 3086.5 grams | Standard Deviation 679.5 |
| Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Weight of the Baby | 3230.1 grams | Standard Deviation 638.71 |
| Group 4: Single Dose (Infant Participants) | Weight of the Baby | 2955.3 grams | Standard Deviation 598.35 |
| Group 5: Placebo (Infant Participants) | Weight of the Baby | 3272.4 grams | Standard Deviation 629.2 |