Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age |
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). |
At Birth, Day 42 and Day 90 |
|
Primary |
Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age |
To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay |
At Birth, Day 42 and Day 90 |
|
Primary |
Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age |
To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
At Birth, Day 42 and Day 90 |
|
Primary |
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum |
To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). |
At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) |
|
Primary |
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum |
To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) |
|
Primary |
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum |
To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) |
|
Primary |
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum |
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). |
At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) |
|
Primary |
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum |
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) |
|
Primary |
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum |
Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) |
|
Secondary |
Ratio of GBS IgG Antibody Levels - Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery |
To evaluate the relationship of serotype-specific Ia GBS IgG antibody levels (anti-Ia) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). |
At Delivery |
|
Secondary |
Ratio of GBS IgG Antibody Levels - Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery |
To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
At Delivery |
|
Secondary |
Ratio of GBS IgG Antibody Levels - Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery |
To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay. |
At Delivery |
|
Secondary |
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes |
Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (= 25 mm). Systemic fever includes subjects with body temperature = 38 °C irrespective of route of measurement. |
Up to 30 minutes post-vaccination |
|
Secondary |
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 |
Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (= 25 mm). Systemic fever includes subjects with body temperature = 38 °C irrespective of route of measurement. |
During Study Days 1-3 (from 6 hours through Day 3 post-vaccination) |
|
Secondary |
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7 |
Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (= 25 mm). Systemic fever includes subjects with body temperature = 38 °C irrespective of route of measurement. |
During Study Days 4-7 |
|
Secondary |
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 |
Percentage and frequency of maternal subjects with solicited local and solicited systemic adverse events up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (= 25 mm). Systemic fever includes subjects with body temperature = 38 °C irrespective of route of measurement. |
During Study Days 1-7 (from 6 hours through Day 7 post-vaccination) |
|
Secondary |
Percentage of Maternal Subjects With Any Unsolicited AEs |
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes inter-current illnesses or injuries and exacerbation of pre-existing conditions. |
From Study Day 1 through Study Day 31 |
|
Secondary |
Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) |
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner. |
From Study Day 1 through Study Day 31 |
|
Secondary |
Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) |
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner. |
From Study Day 32 through Day 180 postpartum |
|
Secondary |
Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal |
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner. |
From Birth through Day 180 of age |
|
Secondary |
Birth Weight of Infants (Mean-Standard Deviation) |
Weight at birth was summarized by reporting the mean and standard deviation, |
At Birth |
|
Secondary |
Birth Weight of Infants (Median, Minimum and Maximum) |
Weight at birth was summarized by reporting the median and the minimum and maximum. |
At Birth |
|
Secondary |
Birth Length and Head Circumference of Infants (Mean - Standard Deviation) |
Length and head circumference at birth were summarized by reporting the mean and standard deviation. |
At Birth |
|
Secondary |
Birth Length and Head Circumference of Infants (Median - Minimum and Maximum) |
Length and head circumference at birth were summarized by reporting the median and minimum and maximum |
At birth |
|
Secondary |
Infants Apgar Scores (Mean - Standard Deviation) |
Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar score between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required. |
At 1, 5 and 10 minutes |
|
Secondary |
Infants Apgar Scores (Median, Minimum and Maximum) |
Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar scores between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required. |
At 1, 5 and 10 minutes |
|
Secondary |
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation) |
Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the mean and standard deviation. |
At Day 180 of age |
|
Secondary |
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum) |
Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the median, minimum and maximum. |
At Day 180 of age |
|