Magnitude of the Antibody Response to and Safety of a GBS... | NCT01412801 | Trialant
NCT01412801
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Sep 12, 2014Estimated
Enrollment
270Actual
Phase
Phase 2
Conditions
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interventions
Group B streptococcus vaccine
Countries
Malawi
South Africa
Protocol Section
Identification Module
NCT ID
NCT01412801
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V98_05
Secondary IDs
Not provided
Brief Title
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Official Title
A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Sep 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2011
Primary Completion Date
Oct 2012Actual
Completion Date
Dec 2012Actual
First Submitted Date
Aug 8, 2011
First Submission Date that Met QC Criteria
Aug 8, 2011
First Posted Date
Aug 9, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 20, 2014
Results First Submitted that Met QC Criteria
Sep 5, 2014
Results First Posted Date
Sep 12, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 5, 2014
Last Update Posted Date
Sep 12, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.
Detailed Description
Not provided
Conditions Module
Conditions
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Keywords
Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
270Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
HIVneg
Experimental
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine.
Biological: Group B streptococcus vaccine
HIVposCD4HIGH
Experimental
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of Group B streptococcus vaccine.
Biological: Group B streptococcus vaccine
HIVposCD4LOW
Experimental
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of Group B streptococcus vaccine
Biological: Group B streptococcus vaccine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Group B streptococcus vaccine
Biological
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
HIVneg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Day of delivery/birth
Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
Day of delivery/birth
Secondary Outcomes
Measure
Description
Time Frame
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.
Day 1, 15, 31 and at Delivery
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pregnant women 18-40 years of age between 24-35 weeks gestation
Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts > 50 cells/µL
Exclusion Criteria:
Women who had CD4+ count ≤ 50 cells/µL
Women who were HIVpos with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations
Heyderman RS, Madhi SA, French N, Cutland C, Ngwira B, Kayambo D, Mboizi R, Koen A, Jose L, Olugbosi M, Wittke F, Slobod K, Dull PM. Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial. Lancet Infect Dis. 2016 May;16(5):546-555. doi: 10.1016/S1473-3099(15)00484-3. Epub 2016 Feb 8.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
All the enrolled subjects are included in the trial. Also,only the mothers who received the glycoconjugates were considered enrolled.
Recruitment Details
Subjects were enrolled at Malawi and South Africa
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
FG001
HIVposCD4HIGH_Maternal
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
HIVposCD4HIGH
HIVposCD4LOW
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.
Day of Delivery
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine
From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
Percentages of Subjects With Solicited Systemic AEs
Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine
From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine
Day 1 to Study Termination, for up to 24 weeks
Percentages of Infants Who Experienced Unsolicited Adverse Events
Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination
Birth to Study Termination, for up to 24 weeks
Bertsham
2013
South Africa
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
FG002
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
FG003
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
FG004
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
FG005
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
FG00091 subjects
FG00189 subjects
FG00290 subjects
FG00391 subjects
FG00488 subjects
FG00587 subjects
COMPLETED
FG00087 subjects
FG00184 subjects
FG00283 subjects
FG00387 subjects
FG00485 subjects
FG00584 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0027 subjects
FG0034 subjects
FG0043 subjects
FG0053 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG0042 subjects
FG0052 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Relocated to another area
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
BG001
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
BG002
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
BG003
HIVposCD4LOW (Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
BG004
HIVposCD4HIGH (Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
BG005
HIVneg (Infants)
Infants born to HIV-antibody negative maternal subjects
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00091
BG00189
BG00290
BG00391
BG00488
BG00587
BG006536
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Standard Deviation
years
Title
Denominators
Categories
Maternal Subjects
Title
Measurements
BG00028.3± 4.8
BG00128.1± 5.2
BG00224.7± 4.4
BG003
Age, Customized
Mean
Standard Deviation
days
Title
Denominators
Categories
Infants
Title
Measurements
BG000NA± NA"Infants' ages only provided here"
BG001NA± NA"Infants' ages only provided here"
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00091
BG00189
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).
Posted
Geometric Mean
95% Confidence Interval
μg/mL
Day of delivery/birth
ID
Title
Description
OG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG001
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG002
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG003
HIVposCD4LOW(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
OG004
HIVposCD4HIGH(Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
OG005
HIVneg(Infants)
Infants born to HIV-antibody negative maternal subjects
Units
Counts
Participants
OG00083
OG00181
OG00283
OG003
Title
Denominators
Categories
GBS serotypes Ia (83, 81, 83, 79, 81, 83)
Title
Measurements
OG0002.07(1.44 to 2.98)
OG0012.31(1.6 to 3.34)
OG0023.98(2.75 to 5.74)
Secondary
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.
FAS (Maternal Subjects in the Exposed Population) who -Secondary objective serum GMC: provided at least one evaluable sample result at day 1 (prior to vaccination), day 15, day 31, or at delivery;- Secondary objective kinetics: provided at least one evaluable serum sample at day 1 (prior to vaccination), day 15, day 31, and at delivery.
Posted
Geometric Mean
95% Confidence Interval
µg/mL
Day 1, 15, 31 and at Delivery
ID
Title
Description
OG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG001
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG002
HIVneg_Maternal
Secondary
Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery
Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.
FAS (Maternal Subjects)
Posted
Number
Percentage of maternal subjects
Day of Delivery
ID
Title
Description
OG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG001
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG002
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
Secondary
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine
Safety Set (Solicited AEs, Maternal Subjects)
Posted
Number
percentage of Subjects
From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
ID
Title
Description
OG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG001
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG002
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
Secondary
Percentages of Subjects With Solicited Systemic AEs
Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine
Safety Set (Solicited AEs, Maternal Subjects)
Posted
Number
percentages of Subjects
From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
ID
Title
Description
OG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG001
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG002
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
Secondary
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine
Safety Set (Unsolicited AEs, Maternal Subjects)
Posted
Number
percentages of subjects
Day 1 to Study Termination, for up to 24 weeks
ID
Title
Description
OG000
HIVposCD4LOW_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG001
HIVposCD4HIGH_Maternal
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
OG002
HIVneg_Maternal
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
Secondary
Percentages of Infants Who Experienced Unsolicited Adverse Events
Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination
Safety Set (Unsolicited AEs, Infants)
Posted
Number
percentages of Infant subjects
Birth to Study Termination, for up to 24 weeks
ID
Title
Description
OG000
HIVposCD4LOW (Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
OG001
HIVposCD4HIGH (Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
OG002
HIVneg (Infants)
Infants born to HIV-antibody negative maternal subjects
Units
Counts
Participants
Primary
Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).
Posted
Geometric Mean
95% Confidence Interval
Ratios
Day of delivery/birth
ID
Title
Description
OG000
HIVposCD4LOW
Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
OG001
HIVposCD4HIGH
Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
Time Frame
Throughout the study period, for up to 24 weeks
Description
All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
HIVposCD4LOW (Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but > 50 cells/μL
17
91
13
91
EG001
HIVposCD4HIGH (Infants)
Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/μL .
16
88
11
88
EG002
HIVneg (Infants)
Infants born to HIV-antibody negative maternal subjects
16
87
7
87
EG003
Total (Infants)
Total number of Infants participated in the study
49
266
31
266
EG004
HIVposCD4LOW_Maternal Subjects
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but > 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
25
90
55
90
EG005
HIVposCD4HIGH_Maternal Subjects
HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
28
89
68
89
EG006
HIVneg_Maternal Subjects
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
29
90
71
90
EG007
Total Maternal Subjects
Total number of Maternal subjects participated in the study
82
269
194
269
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0012 affected88 at risk
EG0020 affected87 at risk
EG0032 affected266 at risk
EG0041 affected90 at risk
EG0050 affected89 at risk
EG0060 affected90 at risk
EG0071 affected269 at risk
DISSEMINATED INTRAVASCULAR COAGULATION
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
HAEMORRHAGIC DISEASE OF NEWBORN
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
CARDIAC ARREST
Cardiac disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
CARDIAC DISORDER
Cardiac disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CHROMOSOMAL DELETION
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CONGENITAL PNEUMONIA
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
PATENT DUCTUS ARTERIOSUS
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
TALIPES
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
TRISOMY 21
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
CONJUNCTIVAL HAEMORRHAGE
Eye disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
GASTRITIS
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
INGUINAL HERNIA, OBSTRUCTIVE
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
UMBILICAL HERNIA
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
FEELING JITTERY
General disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
AMNIOTIC CAVITY INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
BREAST ABSCESS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
BRONCHOPNEUMONIA
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
CELLULITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
ENDOMETRITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
GASTROENTERITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
MALARIA
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
MENINGITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
PNEUMONIA
Infections and infestations
Non-systematic Assessment
EG0002 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
POST PROCEDURAL SEPSIS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
SEPSIS
Infections and infestations
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
SEPSIS NEONATAL
Infections and infestations
Non-systematic Assessment
EG0003 affected91 at risk
EG0015 affected88 at risk
EG0023 affected87 at risk
EG003
SYPHILIS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
PERINEAL INJURY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
UTERINE RUPTURE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
HYPERNATRAEMIA
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0012 affected88 at risk
EG0020 affected87 at risk
EG003
METABOLIC ACIDOSIS
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0021 affected87 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CONVULSION
Nervous system disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
EPILEPSY
Nervous system disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
Nervous system disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0023 affected87 at risk
EG003
PARTIAL SEIZURES
Nervous system disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
VIITH NERVE PARALYSIS
Nervous system disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
BREECH PRESENTATION
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CAPUT SUCCEDANEUM
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
CEPHALO-PELVIC DISPROPORTION
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CERVIX DYSTOCIA
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
ECLAMPSIA
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
FAILED INDUCTION OF LABOUR
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
FALSE LABOUR
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
FOETAL DISTRESS SYNDROME
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0001 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
GESTATIONAL DIABETES
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
GESTATIONAL HYPERTENSION
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
HAEMORRHAGE IN PREGNANCY
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
HYPEREMESIS GRAVIDARUM
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
JAUNDICE NEONATAL
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0012 affected88 at risk
EG0022 affected87 at risk
EG003
LOW BIRTH WEIGHT BABY
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0002 affected91 at risk
EG0012 affected88 at risk
EG0021 affected87 at risk
EG003
POSTPARTUM HAEMORRHAGE
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PRE-ECLAMPSIA
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PREMATURE BABY
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0005 affected91 at risk
EG0013 affected88 at risk
EG0023 affected87 at risk
EG003
PREMATURE DELIVERY
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PREMATURE LABOUR
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PRETERM PREMATURE RUPTURE OF MEMBRANES
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PROLONGED LABOUR
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PROLONGED PREGNANCY
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PROLONGED RUPTURE OF MEMBRANES
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
RETAINED PLACENTA OR MEMBRANES
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
RETAINED PRODUCTS OF CONCEPTION
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
STILLBIRTH
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
THREATENED LABOUR
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
TRANSVERSE PRESENTATION
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
RENAL IMPAIRMENT
Renal and urinary disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
UTERINE CERVIX STENOSIS
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
NEONATAL ASPHYXIA
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0012 affected88 at risk
EG0022 affected87 at risk
EG003
NEONATAL ASPIRATION
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0002 affected91 at risk
EG0011 affected88 at risk
EG0021 affected87 at risk
EG003
NEONATAL RESPIRATORY DISTRESS SYNDROME
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0005 affected91 at risk
EG0012 affected88 at risk
EG0020 affected87 at risk
EG003
RESPIRATORY DISTRESS
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
TRANSIENT TACHYPNOEA OF THE NEWBORN
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0002 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
MELANOSIS
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
PETECHIAE
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CAESAREAN SECTION
Surgical and medical procedures
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
HAEMATOMA
Vascular disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
SHOCK
Vascular disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0011 affected88 at risk
EG0020 affected87 at risk
EG003
SHOCK HAEMORRHAGIC
Vascular disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
SUBGALEAL HAEMATOMA
Vascular disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ABDOMINAL PAIN
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG0031 affected266 at risk
EG0042 affected90 at risk
EG0053 affected89 at risk
EG0065 affected90 at risk
EG00710 affected269 at risk
DIARRHOEA
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0021 affected87 at risk
EG003
NAUSEA
Gastrointestinal disorders
Systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CHILLS
General disorders
Systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
FATIGUE
General disorders
Systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
INJECTION SITE PAIN
General disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
MALAISE
General disorders
Systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PAIN
General disorders
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
Non-systematic Assessment
EG0007 affected91 at risk
EG0013 affected88 at risk
EG0022 affected87 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG00010 affected91 at risk
EG0016 affected88 at risk
EG0023 affected87 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
PERINEAL INJURY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
HEADACHE
Nervous system disorders
Systematic Assessment
EG0000 affected91 at risk
EG0010 affected88 at risk
EG0020 affected87 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected91 at risk
EG0012 affected88 at risk
EG0021 affected87 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
ID
Term
D013290
Streptococcal Infections
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
Ancestor Terms
ID
Term
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
NA
± NA
"Mothers' ages only provided Here"
BG004NA± NA"Mothers' ages only provided Here"
BG005NA± NA"Mothers' ages only provided Here"
BG00627.1± 5.0
NA
± NA
"Infants' ages only provided here"
BG0034.1± 1.6
BG0046.7± 2.5
BG0051.3± 1.1
BG0061.6± 1.0
90
BG00342
BG00440
BG00541
BG006393
Male
BG0000
BG0010
BG0020
BG00349
BG00448
BG00546
BG006143
83
OG00481
OG00583
OG003
1.01
(0.66 to 1.56)
OG0041.22(0.8 to 1.87)
OG0053.91(2.56 to 5.96)
GBS serotypes Ib(74, 80, 82, 44, 56, 57)
Title
Measurements
OG0001.84(1.22 to 2.77)
OG0012.4(1.64 to 3.52)
OG0024.08(2.85 to 5.83)
OG0031.31(0.78 to 2.19)
OG0041.62(1.03 to 2.56)
OG0052.67(1.7 to 4.2)
GBS serotypes III (83, 72, 82, 54, 51, 66)
Title
Measurements
OG0001.07(0.71 to 1.6)
OG0011.03(0.69 to 1.53)
OG0023.61(2.51 to 5.18)
OG0030.6(0.36 to 0.99)
OG0040.52(0.31 to 0.88)
OG0053.88(2.47 to 6.1)
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
Units
Counts
Participants
OG00074
OG00175
OG00277
Title
Denominators
Categories
Serotype Ia Day 1
Title
Measurements
OG0000.24(0.19 to 0.3)
OG0010.25(0.2 to 0.32)
OG0020.38(0.3 to 0.48)
Serotype Ia Day 15
Title
Measurements
OG0002.62(1.64 to 4.17)
OG0012.95(1.86 to 4.69)
OG0025.61(3.56 to 8.84)
Serotype Ia Day 31
Title
Measurements
OG0002.68(1.75 to 4.1)
OG0013.26(2.14 to 4.98)
OG0026.63(4.37 to 10)
Serotype Ia At delivery
Title
Measurements
OG0002.22(1.5 to 3.29)
OG0012.69(1.82 to 3.98)
OG0024.49(3.06 to 6.6)
Serotype Ib Day 1
Title
Measurements
OG0000.51(0.38 to 0.7)
OG0010.36(0.27 to 0.48)
OG0020.4(0.31 to 0.51)
Serotype Ib Day 15
Title
Measurements
OG0002.93(1.73 to 4.95)
OG0013.5(2.17 to 5.65)
OG0026.07(3.98 to 9.26)
Serotype Ib Day 31
Title
Measurements
OG0002.62(1.62 to 4.24)
OG0013.68(2.38 to 5.7)
OG0025.35(3.63 to 7.87)
Serotype Ib At delivery
Title
Measurements
OG0002.12(1.36 to 3.31)
OG0013.04(2.03 to 4.56)
OG0023.84(2.69 to 5.5)
Serotype III Day 1
Title
Measurements
OG0000.12(0.086 to 0.17)
OG0010.099(0.072 to 0.14)
OG0020.14(0.1 to 0.18)
Serotype III Day 15
Title
Measurements
OG0001.24(0.79 to 1.95)
OG0011.52(0.97 to 2.36)
OG0025.9(3.99 to 8.72)
Serotype III Day 31
Title
Measurements
OG0001.51(0.97 to 2.35)
OG0011.31(0.85 to 2.02)
OG0025.35(3.66 to 7.83)
Serotype III At delivery
Title
Measurements
OG0001.25(0.81 to 1.94)
OG0011.07(0.7 to 1.65)
OG0023.8(2.61 to 5.55)
Units
Counts
Participants
OG00083
OG00182
OG00283
Title
Denominators
Categories
≥ 0.2 µg/mL(Serotype Ia)
Title
Measurements
OG000100
OG00199
OG002100
≥ 0.5 µg/mL(Serotype Ia)
Title
Measurements
OG00067
OG00171
OG00282
≥ 1 µg/mL(Serotype Ia)
Title
Measurements
OG00055
OG00159
OG00271
≥ 2 µg/mL(Serotype Ia)
Title
Measurements
OG00051
OG00149
OG00260
≥ 3 µg/mL(Serotype Ia)
Title
Measurements
OG00040
OG00146
OG00254
≥ 5 µg/mL(Serotype Ia)
Title
Measurements
OG00030
OG00141
OG00253
≥ 8 µg/mL(Serotype Ia)
Title
Measurements
OG00022
OG00130
OG00247
≥ 0.1 µg/mL(Serotype Ib)
Title
Measurements
OG00089
OG00198
OG00298
≥ 0.2 µg/mL(Serotype Ib)
Title
Measurements
OG00088
OG00198
OG00298
≥ 0.5 µg/mL(Serotype Ib)
Title
Measurements
OG00083
OG00184
OG00290
≥ 1 µg/mL(Serotype Ib)
Title
Measurements
OG00065
OG00163
OG00269
≥ 2 µg/mL(Serotype Ib)
Title
Measurements
OG00040
OG00141
OG00247
≥ 3 µg/mL(Serotype Ib)
Title
Measurements
OG00028
OG00135
OG00240
≥ 5 µg/mL(Serotype Ib)
Title
Measurements
OG00020
OG00126
OG00228
≥ 8 µg/mL(Serotype Ib)
Title
Measurements
OG00013
OG00117
OG00224
≥ 0.1 µg/mL(Serotype III)
Title
Measurements
OG00096
OG00180
OG00295
≥ 0.2 µg/mL(Serotype III)
Title
Measurements
OG00082
OG00176
OG00289
≥ 0.5 µg/mL(Serotype III)
Title
Measurements
OG00063
OG00151
OG00286
≥ 1 µg/mL(Serotype III)
Title
Measurements
OG00047
OG00141
OG00273
≥ 2 µg/mL(Serotype III)
Title
Measurements
OG00036
OG00124
OG00264
≥ 3 µg/mL(Serotype III)
Title
Measurements
OG00029
OG00118
OG00254
≥ 5 µg/mL(Serotype III)
Title
Measurements
OG00018
OG00113
OG00249
≥ 8 µg/mL(Serotype III)
Title
Measurements
OG00017
OG00112
OG00240
Units
Counts
Participants
OG00088
OG00188
OG00290
Title
Denominators
Categories
Ecchymosis(87, 88, 90)
Title
Measurements
OG0000
OG0010
OG0021
Erythema(87, 88, 89)
Title
Measurements
OG0000
OG0011
OG0021
Induration(87, 88, 90)
Title
Measurements
OG0000
OG0011
OG0020
Swelling(87, 88, 90)
Title
Measurements
OG0000
OG0010
OG0022
Pain(87, 88, 90)
Title
Measurements
OG00018
OG00130
OG00239
Units
Counts
Participants
OG00088
OG00188
OG00290
Title
Denominators
Categories
Chills(87,88,90)
Title
Measurements
OG0009
OG00114
OG00222
Nausea(87,88,89)
Title
Measurements
OG00013
OG00117
OG00222
Malaise(87,88,90)
Title
Measurements
OG00010
OG00119
OG00223
Myalgia(87,88,90)
Title
Measurements
OG0008
OG00117
OG00223
Arthralgia(87,88,90)
Title
Measurements
OG00013
OG00123
OG00229
Headache(87,88,90)
Title
Measurements
OG00024
OG00132
OG00243
Fatigue(87,88,90)
Title
Measurements
OG00024
OG00131
OG00247
Rash(87,88,90)
Title
Measurements
OG0003
OG0011
OG0021
Fever ( ≥ 38°C)(87, 88, 90)
Title
Measurements
OG0003
OG0010
OG0020
Temperature(<38°C)(87, 88,90)
Title
Measurements
OG00097
OG001100
OG002100
Temperature(38-38.4°C)(87, 88,90)
Title
Measurements
OG0001
OG0010
OG0020
Temperature(38.5-38.9°C)(87, 88,90)
Title
Measurements
OG0001
OG0010
OG0020
Temperature(39-39.4°C)(87, 88,90)
Title
Measurements
OG0000
OG0010
OG0020
Temperature(39.5-39.9°C)(87, 88,90)
Title
Measurements
OG0001
OG0010
OG0020
Temperature(≥ 40°C)(87, 88,90)
Title
Measurements
OG0000
OG0010
OG0020
Analgesic antipyr. meds(Other indicators)
Title
Measurements
OG0007
OG00110
OG0029
Stayed home(Other indicators)
Title
Measurements
OG0003
OG0015
OG0029
Units
Counts
Participants
OG00090
OG00189
OG00290
Title
Denominators
Categories
Any AE
Title
Measurements
OG00074
OG00176
OG00278
Possibly related AE
Title
Measurements
OG0007
OG00113
OG00223
SAE
Title
Measurements
OG00028
OG00131
OG00232
Possibly related SAE
Title
Measurements
OG0000
OG0010
OG0020
AE leading to withdrawal from study
Title
Measurements
OG0000
OG0011
OG0020
Medically attended AEs
Title
Measurements
OG00047
OG00149
OG00254
Death
Title
Measurements
OG0000
OG0011
OG0020
OG00091
OG00188
OG00287
Title
Denominators
Categories
Any AE
Title
Measurements
OG00041
OG00149
OG00243
Possibly related AE
Title
Measurements
OG0000
OG0012
OG0021
SAE
Title
Measurements
OG00019
OG00118
OG00218
Possibly related SAE
Title
Measurements
OG0000
OG0010
OG0020
AE leading to withdrawal from study
Title
Measurements
OG0004
OG0012
OG0022
Medically attended AEs
Title
Measurements
OG00023
OG00133
OG00224
Death
Title
Measurements
OG0004
OG0012
OG0022
OG002
HIVneg
Maternal subjects: HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
Infants: Infants born to HIV-antibody negative maternal subjects